The Pharma Legal Handbook: Argentina

All legal aspects surrounding biosimilars & biologics in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

1. Are biosimilar medicines considered the same as generic medicines in your country?

No, biosimilar medicines have their own legal regime. ANMAT does not use any specific term such as “biosimilar” or “biocomparable”, but defines this type of biological medicines as: “medicinal specialties of biological origin whose proposed quali-quantitative composition, therapeutic indications and route of administration, originate in other medicinal specialties of biological origin authorized and registered with the national health authority or other regulatory health authority (reference biological medicine), about which there is evidence of its commercialization and sufficient characterization of its risk-benefit profile”.

 

2. Are all biologic medicines, including biosimilar medicines patentable in your country?

New molecules and new processes for preparing them are deemed patentable as a general principle. There are no specific rules or case law in connection with the patentability of biosimilars. In any case, it should be borne in mind that several inventions related to biological medicines or biosimilars are excluded from patentability. Methods of treatment, for instance, are excluded from patentability under the Argentine Patent Law. Also, the Patent Office’s Patentability Guidelines severely restrict the patentability of inventions in the pharma field such as compositions and formulations, dosage regimes, selection inventions and second medical uses.

 

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

Yes. The registration application for biosimilars is regulated by ANMAT Regulation No. 7,729/2011 and complemented by ANMAT Regulation No. 7,075/2011. The biosimilar products obtained through recombinant DNA are regulated by ANMAT Regulation No. 3,397/2012.

 

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

Is this any different to the requirements for the original Biologics drug?

Biological and biotechnological products have a different registration and authorization procedure from the one applicable to biosimilar products. The registration of original biological or biotechnological products requires the filing of a full dossier whereas the registration of a biosimilar product requires the filing of an abbreviated dossier. Only those biological products containing well characterized proteins may qualify for registration.

The comparability test should show that the biosimilar product is similar to the reference product in terms of quality. Therefore, appropriate physical-chemical and biological trials that allow a detailed characterization of the product should be carried out.

Also, preclinical and clinical studies should be performed on the biosimilar product. Their complexity and scope will be determined on a case-by-case basis and will depend on:

1. The nature of the active substance and its structural complexity (structure/function relationship);
2. Information of “in vivo” performance of the active pharmaceutical ingredient and/or product;
3. Impurities (profiles of compared impurities);
4. Information on the post-marketing performance of similar products, understanding the importance of clinical experience with similar active pharmaceutical ingredients and/or similar products; and
5. The relationship between known adverse effects and molecular characteristics.

 

5. What are the requirements for the choice of the reference comparator product?

The reference product must be authorized by ANMAT and commercialized in Argentina. Alternatively, a foreign authorization may also be considered if registered by a country with high sanitary surveillance. Please see Question 6 below for more information.

 

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

A medicinal specialty of biological origin authorized in a foreign country by the relevant health authority may be considered a reference product if the applicant proves that there is enough experience and knowledge regarding its use and commercialization in the market, and information and/or documentation about its characteristics and specifications. In this sense, the reference product must be authorized and broadly commercialized in the foreign country or group of countries as long as their regulatory institutions and framework are in accordance with those of Argentina. The comparability process will be accompanied by preclinical and clinical studies whose extension will depend on the results obtained during said process.

 

7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?

To date, ANMAT has not issued specific regulations for fixing prices applicable to the products under its control (including biologic and biosimilar products).

 

8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?

Yes, it might because private and public healthcare insurance providers will try to obtain reimbursement of the biosimilar product when is less expensive than the original product.

If a biologic drug and/or a biosimilar are included in the Mandatory Medical Plan (PMO, after its acronym in Spanish), the reimbursement is guaranteed. If that is not the case, the regulations protect the access to treatments considered to be of high cost, but the extension of the coverage may vary.

The reimbursement policy for biosimilars, in practice, might be different because of a joint regulation of the MoH and that Secretary of Trade that gives preference to those nationally manufactured products that are available in the market with the same active ingredient or biosimilar as those manufactured abroad, provided that their final sale price is significantly lower than the average price of the similar/biosimilar foreign manufactured medicines.

 

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

There is no difference between the prescribing and dispensing of biosimilars and the requirements for the original biologic drugs.

 

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

In principle, biological/biosimilar products are considered to be interchangeable.

The Law on Generic Pharmaceutical Products No. 25,649 was issued with the aim of guaranteeing the patients’ right to acquire a prescription drug under its generic name and without being obliged to purchase a specific brand. Therefore, patients can request the pharmacist to provide information of all medical specialties containing the same active pharmaceutical ingredient or a combination of them, the same dosage, same pharmaceutical form and similar units. Pharmacist will be obliged to substitute the prescribed medicine with the same active ingredient, if requested by the patient.

 

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

Specific rules for switching a biologic medicine for a biosimilar is a pending matter to be properly addressed and regulated in Argentina. Interchangeability is up to the treating physician’s medical criterion and patient’s will, in accordance with a reasonable and comprehensive interpretation of local legal framework. Several healthcare professionals’ associations have expressed their rejection to a physician-led switching without the consent of the patient and to a pharmacy-level automatic substitution.

 

12. What are the post-authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

The holder of the marketing authorization of biological or biosimilar products must have an appropriate system for post-marketing pharmacovigilance. A trained professional must be appointed to be in charge of supervision, and adequate measures for the notification of all adverse events that occur in Argentina and in other countries where the same product could be in commercialization.

On the other hand, the marketing authorization holder of a biological and/or biosimilar product will have to file a risk management plan in addition to the post-marketing pharmacovigilance system.

 

13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?

Second medical uses are excluded from patentability under the Patent Office’s patentability guidelines.

 

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

No.

 

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

There are no proposals of reforms to the legal framework of biologic drugs or biosimilars. Nevertheless, the situation could change considering the health emergency declaration (December 23, 2019), established by Law No. 27,541, that strengthens the Ministry of Health’s regulatory powers until December 31, 2022.

 

Also from this Legal Handbook

The low-down on the situation regarding localization in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

As a preliminary comment, please note that to carry out activities in Argentina on a permanent basis, a foreign company has to appoint a local representative (e.g., a distributor), establish a branch, or establish a subsidiary (e.g., a local company).

Argentina has certain regulations encouraging localization in the country, which provide benefits from a tax, customs, and commercial standpoint. Please see Questions 2, 6 and 7 below for more information.

Although the main benefits are from a tax and customs standpoint, it should be noted that the MoH together with the Secretary of Trade have issued a joint regulation regulating the mandatory coverage of certain high-costs medicines by private and public healthcare insurance providers companies by giving preference to those national manufactured products available in the market with the same active ingredient or biosimilar from those manufactured abroad, provided that their final sale price is significantly lower than the average price of the similar/biosimilar foreign manufactured medicines.

 

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

Yes. During years 2020/2021, Argentina made effective certain promotional regimes that provide tax benefits to companies located in Argentina.

1. Biotech Regime: Regarding the pharmaceutical industry, during the year 2018, the Argentine Government regulated the Promotional Regime for Biotechnology Projects, created under Law No. 26,270 (the “Biotech Regime”), which is directed to companies located in Argentina that are working in: (a) R&D projects based on the application of modern biotechnology or (b) projects that apply modern biotechnology for manufacturing goods, performing services or improving existing procedures or products.
   The Biotech Regime provides certain tax benefits such as: (a) VAT reimbursements; (b) accelerated depreciation of capital goods affected to the promoted project, and (c) the granting of tax credit bonds which can be used for paying advances and/ or balances of other federal taxes, among others.

In years 2019 and 2020 additional regulations were issued to effectively implement the Biotech Regime. In particular, in 2020, the Argentine Tax Authority issued General Resolution No. 4,669/2020 which was modified by General Resolution No. 4,934/2021, establishing the requirements for owners of approved projects under the Biotech Regime to apply the fiscal benefits. This resolution makes the Biotech Regime fully operative.

1. Knowledge-Economy Regime: In addition, in year 2019 (under the former administration), the Argentine Congress enacted Law No. 27,506 which provides for a promotional regime for the Knowledge Economy (the “Knowledge-Economy Regime”), that aims to promote economic activities performed in Argentina (such as the creation, design, development, production, implementation or adaptation of products and services) by applying the use of knowledge (supported by progress in science and technology). Law No. 27,506 granted interesting tax and social security advantages to the regime’s beneficiaries.

However, in year 2020, the current administration suspended the implementation of the Knowledge-Economy Regime, and enacted Law No. 27,570 which amended Law No. 27,506 (modifying the requirements to be considered beneficiary of this regime and the scope of the benefits).

Regarding the pharmaceutical industry, the Knowledge-Economy Regime provides for a promotional tax regime for many innovative companies located in Argentina, such as: (a) biotechnology, (b) neurotechnology and genetic engineering, and (c) nanotechnology and nanoscience, including trials and analysis activities. Medical sciences activities linked to research and experimental development tasks are also included.

As in the past regime, to qualify as beneficiary of the “new” Knowledge-Economy Regime, companies must: (A) perform any of the promoted activities under the regime; (B) register with the National Registry of Beneficiaries; and (C) meet at least two of the requirements set forth in applicable regulations: (i) perform continuous improvements in the quality of services, products or processes, (ii) invest in research and development activities for a certain period of time, and /or (iii) have exports of goods and/or services derived from the performance of any of the promoted activities in a minimum percentage that will depend of the kind of activity and the size of the beneficiary).

The benefits under the Knowledge-Economy Regime include:

• Fiscal stability in respect to the benefits granted under the regime;
• Reduction of the general income tax rate, depending on the size of the company (60% for micro and mini companies, 40% for medium companies and 20% for large companies) applicable on the gains derived from the performance of the promoted activities, and possibility of deducting for income tax purposes any amount paid abroad in concept of foreign taxes on the gains derived from the performance of the promoted activities;
• Exemption from value added tax withholdings or payments in advance; and
• Tax credit bonus equivalent to 70% of the social security contributions paid by the company in relation to employees affected to the promoted activities.

Each beneficiary must, however, pay an annual amount of up to 4% per cent of the total tax benefits granted under the Trust Fund for the Development of Entrepreneurial Capital regime.

Please note that the Biotech Regime and the Knowledge-Economy Regime are independent, and that companies located in Argentina that comply with the requirements set forth in each case may apply to both regimes.

In addition, on June 16, 2021, the Argentine Government enacted Law No. 27,630 which amended the Argentine Income Tax Law, and replaced the fixed rate paid by Argentine companies on their corporate income from 30% to a progressive rate ranging from 25% to 35% for tax periods starting on January 1, 2021. Subject to net income amounts, companies will have to pay a fixed amount and a progressive rate over the surplus of the minimum base rate in their category.

 

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

The process of obtaining a market authorization is not impacted by localization policies in Argentina.

 

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

The pricing process for pharmaceutical products is not impacted by localization policies in Argentina.

 

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

The reimbursement of pharmaceutical products is not impacted by localization policies in Argentina.

 

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

Yes. According to Law No. 27,437 the locally manufactured products must have a preferential treatment in public tenders with respect to foreign products.

Preference to offers of goods of locally manufactured products will be granted, among other requirements, when for identical or similar services the price of offers of locally manufactured products is equal to or less than the offered goods that are not of national origin, increased by fifteen percent (15%), when said offers are made by Micro, Small and Medium Companies (“MiPyMEs”, after its acronym in Spanish), and by eight percent (8%) for the other companies.

 

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?

From a tax standpoint, as explained in Question 2, Argentina has recently established (or made effective) two promotional regimes that may have impact for companies located in Argentina which are dedicated to the pharmaceutical industry.

In addition, once the Company has decided to land in Argentina, there may be certain customs and taxation benefits depending on the local jurisdiction (provincial or municipal) where the company is located.

As a general comment, importers/exporters in Argentina must be local entities registered before Customs, as explained below:

I. Customs:

In Argentina there are two different localization policies with customs-related benefits: a) free-trade zones; and b) Law 19,640 for manufacturing operations in Tierra del Fuego.

Free-trade zones are located in different parts of the country and they only have relevant fiscal benefits for those manufacturers that export goods that have undergone at least one industrial process in the free-trade zone. The main benefit is to exempt from export duties the higher value of the final goods.

Law No 19,640 splits the Argentine territory in two different customs territories, separating Tierra del Fuego from mainland Argentina. Even though imports to both territories have the same import duties regime, the import of goods originated in Tierra del Fuego –under the regime provided for in Law No 19,640– to mainland Argentina is not subject to import duties, among other benefits.

 

II. Taxation:

Argentina has a federal organization, which consists in three levels of governments: (i) Federal Government, (ii) Provincial Governments and (iii) Municipal Governments. According to Argentine Constitution, all three levels are entitled to establish and collect taxes under their own regulations.

At federal level, applicable taxes (mainly: income tax, value added tax, tax on debits and credits in bank accounts, and personal assets tax) and applicable tax benefits are in principle not impacted by localization policies within Argentina. In other words, for federal tax purposes, is the same being located in the City of Buenos Aires or in the province of Mendoza.

However, there may be certain promotional regimes for different industries depending on whether they are located. For example, companies located in Tierra del Fuego which manufacture different kind of industrial goods (such as pharmaceutical products) therein, could apply for the tax benefits granted under the Promotional Tax Regime set forth by Law No. 19,640 (which promotes the development of manufacturing operations within Tierra del Fuego). In 2021, this Regime was extended until 2038.

At local level (both provincial and municipal), the level of taxation on activities related to the research, manufacturing, processing and/or trade of pharmaceutical products may vary depending on the jurisdiction where the company is located. For example, certain provincial governments may offer tax exemptions for manufacturing operations carried on in their territories, while others may subject those same activities to taxation.

 

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

No.

 

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

So far, we are not aware of any project for implementing further localization policies in Argentina.

 

Also from this Legal Handbook

Keen to learn more about orphan drugs & rare diseases in Argentina? Read on! Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

1. What is the definition of Rare Diseases in your country?

According to Law No. 26,689 on Rare Diseases, rare diseases are considered to be those whose prevalence in the population is equal to or less than one in two thousand (1:2000) people, in accordance to the national epidemiological situation. On February 12, 2021, the Ministry of Health issued Regulation No.  641/2021 which approved a list of rare diseases, according to the prevalence of such diseases in the country.

 

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

Yes. ANMAT Regulation No. 4,622/2012 states that Orphan Drugs are those intended for the prevention, diagnosis and/or treatment of rare diseases, for which there are no available, effective and safe treatments or that they are inadequate.

 

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

The regulatory framework for the authorization of an Orphan Drug in Argentina is provided in ANMAT Regulation No. 4,622/2012. It establishes that medicinal specialties intended for the prevention, diagnosis and/or treatment of rare diseases may be registered and granted “under special conditions”. This regulatory framework is based on Rare Disease status, as defined by Law 26,689 and Annex I of ANMAT Regulation No. 4,622/2012.

 

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

Pharmaceutical companies can request the registration of orphan drugs by submitting complete information from the early phases of investigation (preclinical phase, and phases I and/or II of pharmacological clinical trials), as stated in ANMAT Regulation No. 4,622/2012 and clinical trials regulations.

 

5. Is there an expedited pathway for Orphan Drugs?

There is an expedited pathway for registering orphan drugs that are already registered in one of the countries included in Annex I of Executive Decree No. 150/1992 (countries with high sanitary surveillance, such us: Denmark, Japan, the U.S.A., Israel, Germany, the U.K., Spain, Italy, and France) and that have completed the pharmacological clinical trials phase III. This procedure consists on registering the orphan drug by submitting the foreign marketing authorization, bioavailability data and a project of label, leaflet and prospect. The orphan drug will be registered under the same conditions of registration and commercialization authorized in the Annex I country.

 

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

Yes, but only for product registration and for compassionate use purposes. For registration purposes, the countries recognized are listed in Annexes I and II of Executive Decree No. 150/1992. For compassionate use, the only countries recognized are the ones listed in Annex I of Executive Decree No. 150/1992. Please see Question 5 above for more detail.

 

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?

Orphan Drugs can be reimbursed by public and/or private healthcare insurance providers if such drugs are included in the Mandatory Medical Plan (PMO, after its acronym in Spanish). The Decree No 794/2015 (which regulates Law No. 26,689 on Rare Diseases) states that patients with rare diseases will have PMO treatment coverage. However, it does not determine the extent of the additional treatment coverage of medicines/treatment beyond the scope of the PMO. According to Law No. 26,689, there will be a special coverage for Orphan Drugs though it has not been implemented yet.

 

8. How are the prices of Orphan Drugs regulated?

There is no Orphan Drugs pricing regulation in Argentina so far. Since 2014, ANMAT has issued regulations aimed at compelling the holders of marketing authorization certificates to report the suggested price of sale of their products, in order to publish such reference prices on its website in the National Vademecum of Medicines.

Notwithstanding the lack of a more specific regulatory framework regarding pricing, be noted that there have been precedents where the MoH fixed prices for certain high-cost orphan drugs.

 

9. In case of reference price based on a basket of countries, what countries are included?

No reference prices are in place in Argentine regulations for Orphan Drugs.

 

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

There are vast legal/judicial developments in relation to orphan drugs in Argentina. Leading cases involve health claims filed by patients requesting treatment coverage against their public or private healthcare insurance providers to cover high cost drugs, including orphan drugs. The sanction of Law No. 26,689 on Rare Diseases and ANMAT Regulation No. 4,622/2012 has led to a more regulated scenario for orphan drugs in Argentina since 2011. In addition, there has been vast case law involving orphan drugs treatment coverage.

 

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

Yes.

• Creation of the Argentine Health Technology Assessment Agency (“AGNET”, after its acronym in Spanish). The Bill was filed in March 2022, so it should be filed again to be voted. The AGNET is a very sensitive issue for the local pharmaceutical industry, as it will ultimately be the body that determines through certain studies which medicines, medical devices and procedures, among other products, will be incorporated into the healthcare system’s benefits for their financing and/or coverage. The Bill states that the AGNET will be the consulting body in judicial proceedings where health issues are being discussed. Currently, reports are under the scope of the CONETEC.

Also from this Legal Handbook

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

The usage of Cannabinoid Drugs in Argentina is  authorized for medicinal purposes (medicinal cannabis). Please see Questions 12 to 14 of this Chapter for further information about medicinal cannabis.

Cannabinoid Drugs (non-medicinal) are considered as “narcotics” and therefore their commercialization is prohibited by the applicable laws in force (Section 3, Law on Narcotics No. 17,818). In fact, cannabis, cannabis derived products, tetrahydrocannabinol (“THC”) and synthetic cannabinoids substances are considered as narcotics under criminal regulation (Annex I and Annex II, Decree No. 560/19).

In this context, ANMAT Regulation No. 885/2010 adopts the following definitions (aligned with paragraph 9, Section 77, Criminal Code):

1. Psychotropic: any natural or synthetic substance capable of influencing the psychic functions by its action on the central nervous system;
2. Psychotropic drug: any pharmaceutical product composed of psychotropic substances, used as a treatment of psychic or neurological disorders; and
3. Narcotic: any psychotropic substance with high potential to produce abusive and/or dependent behaviour (psychological/physical, with a similar profile to morphine, cocaine, marijuana, etc.), acting on its own or through the conversion into an active substance that exerts these effects.

As from November 2021, the import, manufacture and commercialization of specific cannabidiol (“CBD”) cosmetic products is also authorized in Argentina (ANMAT Regulation No. 8,504/21) for those CBD cosmetic products that do not contain more than 0.2% w/w of THC, which must obtain a sanitary permit before ANMAT as a Grade II cosmetic product.

As from May 2022, specifics sanitary permits shall be obtained before the sanitary authority to engage production, harvest, deposit transport, distribution, and other commercial activities with cannabis seeds, cannabis (plant), and cannabis derived products for strict medical purposes. Also, as from May 2022, the use of hemp (i.e., cannabis seeds, and/or cannabis plant that does not exceed a certain limit of THC) and its derivatives for other industrial purposes is also authorized (if the required sanitary permits are obtained).

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The main regulatory authorities with jurisdiction over Cannabinoid Drugs are the Ministry of Health (“MoH”), the National Comprehensive Drug Policy Department (the “SEDRONAR”, after its acronym in Spanish), the National Agency of Medicines, Foods and Medical Technology (the “ANMAT”, after its acronym in Spanish) and the new National Regulatory Agency of the Hemp and Medicinal Cannabis Industry (“ARICCAME”, after its acronym in Spanish).

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

No.

 

4. Which are the cannabinoid drugs that have received market approval to date?

To date, there are a few medicinal Cannabinoid Drugs (with CBD as active ingredient) that have been authorized by ANMAT and by other provincial sanitary health authorities for commercialization purposes. For example, “Convupidiol” and “Kanbis” are CBD oils that are produced by Argentine laboratories, are authorized by ANMAT and are sold under filed prescription.

 

5. Who can prescribe Cannabinoid Drugs?

Physicians can prescribe Cannabinoid Drugs intended for therapeutic/medicinal purposes only (medicinal use). Please see Question 19 of this Chapter for information regarding the prescription of medicinal cannabis.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No.

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Please see Question 19 below for information regarding the prescription of medicinal cannabis.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Some cannabinoid drugs and cannabis derivatives may be distributed, for medicinal use, under the Program (as defined below in Question 12 and further explained in Question 18 of this chapter). As from May 2022, specifics permits shall be obtained before ARICCAME to engage production, import, harvest, deposit, transport, distribution, and other commercial activities with cannabis seeds, cannabis (plant), and cannabis derived products.

 

9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?

No.

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

Yes. MoH Regulation No. 781/2022 and the Bill No.47/21 “Regulatory Framework for the Development of the Medicinal Cannabis Industry and Industrial Hemp” (recently approved by Congress) significantly modify the regulation of Cannabinoid Drugs in Argentina. In this context, further changes, and regulations (e.g., complementary and procedural) shall be issued and are soon to come.

11. When are they likely to come into force?

There is no specific date for these complementary regulations to come into force.

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Yes. Law No. 27,350 and its regulatory decree No. 883/2020 provide the regulatory framework for the medicinal, therapeutic and/or palliative use of the Cannabis plant and its by-products through the creation of the National Program for the Study and Research of the Medicinal Use of the Cannabis Plant and its By-products and Non-Conventional Treatments (the “Program”).

One of the Program’s purposes is to grant access to medicinal cannabis for those patients that are prescribed with it. The Program also seeks to supply the local medicinal cannabis market through the production handled by the Argentine Government and declares that the production will be prioritized and promoted through state laboratories

In addition to the Program, there is an exceptional access regime regulated by MoH Regulation No. 654/2021, that allows the importation of non-registered products that contain by-products of the Cannabis plant. This regime is exclusively intended for scientific research and for individual patients.

Furthermore, MoH Regulation No. 781/2022 shall be complementary to Law No. 27,350 and its regulatory decree No. 883/2020. In this context, cannabis-based vegetable products and its derivatives intended for human medicine are authorized products in the country and shall be differentiated from medicines regulated by Decree No. 150/1992, and from herbal medicines products. As from April 2022, any medical product that contains as active pharmaceutical ingredient(s) (API) one or more natural cannabinoid shall be classified into this new product category “Cannabis-based vegetable products and its derivatives intended for human medicine”.

Last but not least, on May 5^th 2022, the Congress approved Bill No.47/21 that will coexist with the former regulation (i.e. Law No. 27,350 and Decree No. 883/2020), and establishes the main regulatory framework for the development of the industry of medicinal cannabis and industrial hemp.

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

ARICCAME was recently created, and it is a decentralized body within the Ministry of Productive Development that shall (i) regulate, manage, and supervise the manufacture chain of cannabis; (ii) grant authorizations to import, cultivate, manufacture, commercialize, export, and acquire seeds of the cannabis plant, cannabis, and its derived products for medicinal and industrial purposes; and (iii) coordinate regulation and activities together with other public organisms (e.g., MoH, ANMAT, the federal tax authority (“AFIP”), etc); among other matters.

In the context of the Program, the National MoH is another  authority in charge of regulating medicinal cannabis. For those provinces that adhere to the Law No. 27,350, the local health authorities can also grant authorizations and have their own registries, provided that the National MoH is notified.

ANMAT has jurisdiction over the import of cannabis and its by-products In regards with cannabis-based vegetable medicines, ANMAT is the authority in charge of granting licenses (to manufacture, export, import, distribute and transport the product across provinces), and issuing complementary and procedural regulation (Section 5 and 7, MoH Regulation No. 781/22).

The National Scientific and Technical Research Council (the “CONICET”, after its acronym in Spanish) and the National Agricultural Technology Institute (the “INTA”, after its acronym in Spanish) are authorized to grow cannabis for medical research purposes and for the production of the medicine to be provided to patients enrolled in the Program (Section 6, Annex I, Decree No. 883/2020).  As per the recent regulation, producers duly authorized by ARICCAME may also provide supplies and derivatives for the fulfilment of the Program.

The National Seed Institute (“INASE”, after its acronym in Spanish) regulates the conditions for the manufacture, propagation, handling, and conditioning activities carried out in greenhouses and/or fields growing cannabis.

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

However, Law No. 27,350 and its regulatory decree No. 883/2020 state that patients that do not have health coverage, have the right to have access to said medicinal specialties free of charge. Otherwise, the healthcare insurance providers must guarantee access to the treatment prescribed. If the patient applies for medicinal cannabis’ authorization from ANMAT via the Cannabis Exceptional Access Regime, the patient or their healthcare insurance provider, on their behalf, will be purchasing the product from abroad.

Furthermore, MoH Regulation No. 781/2022, creates a new category “cannabis-based vegetable products and derivatives intended for use and application in human medicine” for authorizing the commercialization of any drug that contains as Active Pharmaceutical Ingredient(s) one or more cannabinoids from plant origin. In this case, psychotropic regulation will apply to those products that have a THC concentration over 0.3% w/w.

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

As per Law No. 27,350 and its regulatory decree No. 883/2020, the MoH regulates the production of medicinal cannabis for the purpose of the Program. The MoH authorizes the cultivation of cannabis by the CONICET and the INTA for medical and/or scientific research purposes, as well as to prepare the substance for treatments. The legislation states that production must be prioritized and promoted through the state laboratories nucleated in the National Agency of Public Laboratories (“ANLAP”, after its acronym in Spanish).

However, patients can register in the Cannabis Program Registry (“REPROCANN”, after its acronym in Spanish) to obtain authorization to cultivate cannabis by themselves, through a family member, a third person or a civil organization authorized by the MoH.

On the other hand, ANMAT shall grant licenses and permits for the commercialization of cannabis-based vegetable medicines (MoH Regulation No. 781/22). ANMAT is also in charge of authorizing the import of medicinal cannabis and its by-products for patients who have a medical indication to use the cannabis plant and its derivatives, via the Cannabis Exceptional Access Regime.

Last, the new ARICCAME agency will regulate, control and grant authorizations and permits for the production, import/export, harvest, deposit transport, distribution, and other commercial activities with cannabis seeds, cannabis (plant), and cannabis derived products (further complementary regulation shall be issued and consequently it is yet to be enforced).

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Please see Questions 13 and 15.

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Decree No. 883/2020 states that dispensation of medicinal cannabis will be through the National Bank of Oncologic Drugs and/or authorized pharmacies.

MoH Regulation No. 781/2022 states that advertising of cannabis- based vegetable products and the use of free drug samples are activities strictly forbidden. Moreover, those products shall be sold under medical prescription at authorized pharmacies (Section 8 and 9).

 

18. How can patients obtain Medicinal Cannabis?

Patients can obtain prescribed medicinal cannabis through the Program and through the Cannabis Exceptional Access Regime. Patients can also cultivate by enrolling in the REPROCANN, provided they have the corresponding medical prescription.  Furthermore, patients may access by purchasing medicinal specialties duly registered by the sanitary health authority (sold under prescription) and/or by acquiring a cannabis pharmaceutical compound from duly authorized pharmacies.

 

19. Who can prescribe Medicinal Cannabis?

Duly licensed physicians can prescribe medicinal cannabis for a specific treatment of a patient.

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

No.

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

Please see Question 8 above.

 

22. Where is Medicinal Cannabis available?

Decree No. 883/2020 states that dispensation of medicinal cannabis will be through the National Bank of Oncologic Drugs and/or authorized pharmacies (Section 10). In addition, Cannabis- based vegetable products shall be sold under prescription at authorized pharmacies (Section 8, MoH Regulation No. 781/2022).

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

No.

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

Yes. Further changes and regulations (e.g., complementary and/or procedural) are expected. For further reference, please see Question 10 of this Chapter above.

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Yes. The Law on Narcotics No. 17,818 establishes the requirements for the activities of import, export, manufacture, fractioning, distribution and commercialization of narcotics. The Law classifies different opioids drugs as narcotics, placing them in different Schedules (Schedule I, II, III and IV) depending on the risks that the different opioids drugs may have on patients’ health.

 

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

Regulatory authorities with jurisdiction over Opioid Drugs are the MoH, ANMAT and the National Institute of Cancer (the “INC” after its acronym in Spanish). Within the INC, the Palliative Care Program (“PCP”) was created by MoH Regulation No. 1253/16. The PCP aims to provide an adequate and continuous provision and distribution of Opioid Drugs in Argentine territory, eliminating accessibility barriers to such drugs.

 

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

Opioid drugs must obtain the marketing authorization approval from ANMAT. So far, ANMAT has not issued specific regulations for fixing prices of the products under its control.

 

28. Which are the Opioid drugs that have received market approval to date?

There are several marketing authorizations granted for opioid drugs registered with ANMAT. Those registered marketing authorizations cover different active ingredients such as methadone, morphine, buprenorphine, papaverine, oxycodone, among others.

 

29. Who can prescribe Opioid Drugs?

Duly licensed physicians can prescribe the use of opioid drugs. Also, duly licensed veterinarians may prescribe Opioid Drugs to be used in veterinary medicine, as provided by Section 21 of Law No. 17,818.

 

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

No.

 

31. What approvals or notifications are required to prescribe Opioid Drugs?

In principle, physicians are not required to notify the authorities (save for the scenario in which an overdose is prescribed) but pharmacists do. For medicinal specialties that contain narcotics included in Schedule I or certain narcotics included in Schedule II, pharmacists must notify the health authority about their delivery within 8 days and must have a registry in accordance with Section 16 of Law No. 17,818.

The prescriptions of opioid drugs must comply with the following requirements in accordance with Law No. 17,818:

• Be written in Spanish and in a legible form.
• Be original, in good condition and without any alteration. Photocopies are not valid.

For opioid drugs included in Schedules I and II (that exceed the concentrations set out in Schedule III), prescriptions must:

• Be extended on formalized forms in duplicate, according to the form authorized by the appropriate Argentine sanitary authority.
• Indicate the denomination or formula and its prescription, with the quantities expressed in letters.
• Indicate name, surname and address of the patient.
• Not exceed the dose for ten days of treatment.

 

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

The sale of drugs, medicines and pharmaceutical products including opioid drugs to the public can only be carried out in duly licensed pharmacies (Law No. 17,565 for the Pharmacy Practice). Likewise, the INC is authorized to distribute opioid drugs to public hospitals.

 

33. Is there a list of retailers/ distributors authorized to sell Opioid Drugs?

No.

 

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

Currently, there are no bills in Congress on Opioid drugs.

 

35. When are they likely to come into force?

Currently, there are no bills in Congress on Opioid Drugs.

 

Also from this Legal Handbook

An insight into upcoming regulatory reforms affecting Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

1. Are there proposals for reform or significant change to the healthcare system?

There are no proposals for reform or significant change of the healthcare system in the short term. Nonetheless, due to the COVID-19 pandemic, several new regulations and laws have passed. A proposal for a significant change to the healthcare system is Bill No. 0101-S-2020 on telehealth, already approved by the Senate. Such bill seeks to promote the provision of medical assistance services to the population through telemedicine networks that allow remote patient care. It establishes a regulatory framework for consultations by electronic means to improve people’s accessibility to the system and the quality of care, avoiding unnecessary or prohibited transfers, even after the COVID-19 pandemic.

The new telemedicine law will cover, if approved by both Chambers, all agents and providers of the National Health Insurance System and prepaid medicine companies, who will have to adapt their medical assistance services.

In this context, in March 2022 the Ministry of Health issued the Telehealth Good Practices that shall apply to virtual medical visits at the public, private and social security sector (MoH Regulation No.  581/2022).

Creation of the Argentine Health Technology Agency (AGNET)

The creation of the AGNET is a very sensitive issue for the local pharmaceutical industry since it will ultimately be the body that determines through certain studies which medicines, medical devices, procedures, etc., will be incorporated into the set of benefits for their financing and/or coverage (currently, under CONETEC’s scope).

The bill No. 0002-S-2022 specifically establishes that AGNET may intervene and will be the consulting body at judicial proceedings where health issues are discussed.

The creation of the AGNET is currently at Congress for review (it was filed on March 2022).

 

2. When are they likely to come into force?

There is no specific date for these laws to come into force. The voting date for these bills has not been appointed yet.

 

Also from this Legal Handbook

A legal briefing on patents and trademarks in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

1. What are the basic requirements to obtain patent and trademark protection?

Patents

To obtain patent protection in Argentina, it is necessary to file a patent application with the National Institute of Industrial Property (the “INPI” after its acronym in Spanish).

The specific requirements for obtaining patent protection are patentable subject matter, novelty, inventive activity, industrial applicability, sufficient disclosure, clarity, support and best mode. Also, the inventions may not be illegal or immoral.

 

Trademarks

To obtain trademark protection, a trademark application must be filed with INPI. Exceptionally the Argentine courts have granted a measure of protection to unregistered trademarks, that is de facto trademarks and foreign trademarks not registered in Argentina (see Question 5).

The specific requirements for obtaining trademark protection in Argentina are allowability, novelty and distinctiveness (of the signs involved).

 

2. What agencies or bodies regulate patents and trademarks?

Patent and trademark applications must be prosecuted before the INPI. Patent and trademark infringement issues must be brought before the Federal Courts.

Patent invalidity actions must also be brought before the Federal Courts.

As of 2018, trademark oppositions are decided by the INPI, whose rulings may be appealed to the Federal Court of Appeals. As discussed in more detail in Question 4, trademark cancellation is decided by the INPI and likewise may be appealed to the Federal Court of Appeals, except for cases involving bad faith registrations or registrations made with a view to their subsequent sale, which may only be decided by the Federal Courts.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Patents

As a general principle, all products, substances and processes are patentable provided that they comply with the patent requirements referred to above.

As an exception, the Argentine Patent Law excludes from patentability (I) methods of treatment and diagnostic methods; (II) preexisting biological or genetic material; and (III) essentially biological processes.

It should also be noted that in 2012 new internal guidelines for examining chemical-pharmaceutical patent applications entered into force. These guidelines severely restricted the patentability of certain categories of inventions in the pharmaceutical field, including polymorphs, salts, esters and other kinds of selection inventions, formulations, compositions of known substances and second medical uses. The validity of those guidelines has been challenged but there is yet no case law on this matter.

Also, in 2015 the Argentine Patent Office issued specific guidelines on biotechnological inventions which provide additional guidance on how sequences, transformation events and plant and animal parts and components may be claimed.

 

Trademarks

The statutory definition of what kind of signs may be registered as a trademark is broad: any sign having distinctive capacity (Section 1 of the Argentine Trademark Law).

The most relevant signs not allowed to be registered as trademarks are the following: (I) necessary or usual designations; (II) descriptive designations; (III) generic designations; (IV) generally used signs; (V) the necessary shape of the goods; (VI) the natural color of the products or just one color applied to them; (VII) trademarks identical or similar to others already registered or applied for; (VIII) deceptive signs; (IX) indications of local or foreign origin; (X) scandalous marks; (XI) official signs; (XII) names, pseudonyms or portraits of third parties; and (XIII) slogans lacking originality.

 

4. How can patents and trademarks be revoked?

Patents

Once a patent is granted, it can only be revoked through a judicial action before the Federal Courts. Broadly speaking, patents may be revoked provided that they fail to meet either of the legal requirements described above.

The judicial action may be brought by anyone having legitimate interest. The invalidity action entails trial lawsuit before the federal court of first instance and ordinarily requires the appointment of at least one official expert. The decision of the court of first instance may be appealed at the Federal Court of Appeals. A further appeal before the Supreme Court is only allowed in exceptional cases. There are no specialized patent courts in Argentina.

 

Trademarks

Trademark registrations, on the other hand, can be sometimes cancelled by INPI, but such decisions may be reviewed by the courts. Cancellation shall ensue in two situations: because the registration is invalid (nullity), or because the trademark has not been used within the prescribed terms (lapsing).

A registration is invalid if (I) it was granted contra legem; (II) it was obtained “by someone who, at the time of filing the application, knew or should have known that [the trademark] belonged to someone else”; or (III) it was made “with a view to its subsequent sale by someone who regularly registers trademarks with such a purpose” (Section 24, paragraphs a), b) and c), of the Argentine Trademark Law). The broad provision of the abovementioned paragraph a) (registration made contra legem) encompasses all situations where the registration was granted but should have been refused, i.e., when the trademark was indicative, descriptive, generic, scandalous, barred by a specific reason, etc.

INPI has the authority to cancel a registration on the grounds of invalidity when registration has been granted contra legem. On the other hand, only the Federal Courts, and not INPI, may cancel a trademark registration obtained by someone who knew or should have known that it belonged to someone else or when the registration was carried out for its subsequent sale by someone habitually dealing in this activity (Section 24, paragraphs b) and c), of the Argentine Trademark Law).

Furthermore, INPI may declare that a registration has lapsed due to failure to use the mark, even in part (i.e., in connection with specific goods or services) within five (5) years prior to the request for cancellation, unless non-use is justified by force majeure (Section 26, paragraph 1, of the Argentine Trademark Law).

INPI’s rulings to cancel a registration (either due to invalidity or non-use) may be appealed before the Federal Courts, and the appeal must be filed within thirty (30) business days from notice. Some of these provisions are not operative yet and must be supplemented by specific government regulations.

 

5. Are foreign patents and trademarks recognized and under what circumstances?

Patents

Patent applications filed abroad enjoy a 12-month priority right under the terms of the Paris Convention. It should be noted, however, that Argentina is not yet a member of the Patent Cooperation Treaty (PCT).

Additionally, patents granted abroad may be useful for accelerating the prosecution of an equivalent patent application pending in Argentina. In this regard, an internal regulation of INPI provides that Argentine patent applications will be considered to meet all substantial patentability requirements if it is shown that a patent has been granted abroad for the same invention by a foreign Patent Office carrying out substantive examination in a country whose Patent Law has the same substantive requirements as the Argentine law, provided the subject matter is patentable in Argentina.

 

Trademarks

To enjoy protection in Argentina trademarks must be registered with INPI. Applications filed in Argentina may claim the 6-month Convention priority.

Exceptionally the courts have recognized some degree of protection to foreign registrations, in order to overcome a notice of opposition, or to support it, or even an injunction or a cancellation. The grounds therefor were the protection of the de facto user or foreign owner’s clientele, or bad faith in the registrant. The stipulation of Section 24, paragraph b), of the Argentine Trademark Law, according to which a trademark registration may be cancelled if it was obtained “by someone that, at the time of filing the application, knew or should have known that it belonged to someone else”, was introduced in 1980 and has originated case law dating back to 1961.

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

No, Argentine law does not provide for any non-patent/trademark barriers to competition to protect medicines or devices. In particular, Argentine law does not provide for regulatory data protection. Moreover, there is no patent linkage in Argentina.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

Patents

As explained in Question 3 above, all products, substances and processes are patentable provided that they comply with the patent requirements referred to above.

As an exception, the Argentine Patent Law excludes from patentability (I) methods of treatment and diagnostic methods; (II) preexisting biological or genetic material; and (III) essentially biological processes. The INPI also introduced internal guidelines which severely restrict the patentability of certain categories of inventions in the pharmaceutical field. The validity of those guidelines has been challenged but there is yet no case law on this matter (Please see Question 3 above)

 

Trademarks

There are no restrictions on the types of medicines or devices that can be granted trademark protection.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

No. Argentine law does not provide for the registration of license agreements. As an exception, certain license agreements may be registered before INPI for tax purposes, although the tax benefits offered by the Technology Transfer Law may only be enjoyed in those cases where an Argentine resident acts as the licensee and a non-resident as the licensor.

 

Also from this Legal Handbook

Intro to product liability in Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

1. What types of liability are recognized in your jurisdiction?

In general terms, liability arises from provisions in the Argentine Constitution, the Civil and Commercial National Code, the Criminal Code, and other laws that apply to specific cases such as the Corporate Criminal Liability Law, the Consumer Protection Law, Fair-Trading Decree, the Law on Medicines, etc. The standards to determine damages are high.

Penalties for non-compliance with the local legal framework vary depending on the type and degree of infringement, for example, potential risk to patients’ health, degree of intentionality, recidivism, unfair competition, and so on. These can be administrative, civil, or criminal sanctions.

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

There are some specific laws ruling the pharmaceutical and medical devices activities such as the Law on Medicines, the Consumer Protection Law, Fair-Trading Decree and other laws and regulations that set forth obligations and responsibilities for the parties involved in the pharmaceutical and medical devices business. Besides the general liabilities involving any business or activity, the pharmaceutical and medical devices business has additional regulations concerning liability with the aim of protecting the population health, due to the specific risk surrounding the activity.

Infringements to pharmaceutical and medical devices local regulations follow the penalties or preventive measures provided in the Law on Medicines No. 16,463, and Decree No. 341/1992 (and complementary regulations), and would make the company holder of the MA (jointly with its technical director) liable for such penalties.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

All the parties involved in the manufacturing and commercialization of medicines and medical devices can be liable in civil claims for damages derived from their acts. The executives, employees and representatives can be liable due to the lack of diligence in their tasks or in case they intentionally seek to breach the law.

According to the Law on Medicines, the holder of the MA and its technical director are jointly and severally liable for the purity and legitimacy of the products and drugs released into the market.

Furthermore, Consumer Protection Law (“CPL”) establishes the strict, joint and several liability of the producer, manufacturer, distributor, supplier, retailer and anyone using a brand or trademark on the product or service for damages arising from the risk or defect of the products or services. The carrier is responsible for the damages caused to the product as a consequence of or on the occasion of the service. Consumers have the right to take individual actions if their CPL rights are affected or threatened.

 

4. How can a liability claim be brought?

The claim can be brought by the Government Authority for infringements to the local regulatory framework, by a competitor (for non-compliance with the Fair-trading Decree), or by an individual (due to breaches to Consumer Protection Law).

The Argentine Civil and Commercial Code introduced changes to the statute of limitations regime, establishing as a general rule a shorter period (five years). It considers the forfeiture of rights on a separate basis.

The statute of limitations for a civil liability claim is three years, including consumer liability claims, unless any other applicable law provides a more favourable term for the consumer.

The statute of limitation for actions arising from the Law on Medicines is five (5) years. This term is interrupted if another violation to the Law on Medicines or its complementary regulations is committed.

 

5. What defenses are available?

There are multiple defences available, depending on the type of infringement and the government agency and/or parties involved in the claim.

 

Also from this Legal Handbook

The environment surrounding traditional and OTC products in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Herbal and vegetable medicines are regulated by ANMAT. They are defined as medicine that contains as an active ingredient one or more plant medicines, or one or more preparations of plant medicines, or one or more plant medicines in combination with one or more preparations of plant medicines.

All activities related to the preparation and commercialization of these medicines may only be carried out with the prior authorization of the ANMAT, in facilities duly authorized, under the technical direction of a pharmaceutical professional.

Herbal medicines and herbal medicines of traditional use may not contain synthetic or natural isolated active substances in their composition. Products containing synthetic or natural isolated active substances will be considered as medicinal specialties.

The labelling of herbal medicines and herbal medicines of traditional use may not indicate uses or applications other than those authorized.

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Herbal and vegetable medicines advertisement and marketing is regulated under ANMAT Regulation No. 4,980/05. Please see answer to Question 20 of Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

The advertising of herbal and vegetable medicines addressed to the general public may present the product’s objectively demonstrated properties without deception or misleading, providing accurate, precise and clear information according to its use and dosage in accordance with the scientific information approved by ANMAT. The promotion must be based on the characteristics of the product and its proven characteristics for the conditions recognized in the indications authorized by ANMAT. In the event that the advertising makes reference to the dosage and posology of the product, it needs to comply with the provisions of the prospect. It is a condition for this promotion and advertisement to be carried out in Spanish, in accessible and understandable language.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Minimum regulatory requirements for over-the-counter (non-prescription) medicines:

• That the medicinal specialty has demonstrated efficacy and safety over time, to be used in the relief of symptoms or signs easily recognizable by the user.
• That has a wide therapeutic margin in such a way that the voluntary or involuntary administration of a dose higher than recommended or for an unapproved use, or the use for a longer time, does not represent a serious damage to the health of the population; nor that its use in accordance with approved uses masks serious diseases, nor delay the diagnosis and treatment of an underlying condition.
• That does not generate tolerance or dependency and that is not susceptible to abuse.
• That the administration way be exclusively oral or topical.
• That the duration of treatment is limited to the proposed indication (posology).
• That the units of sale or presentations that are requested for said medicinal specialties adjust to the time of treatment approved in their respective leaflet.
• That the medicinal specialty has been commercialized under the condition of sale under prescription in the country, at least during the last 5 years, without having presented reports of serious adverse events, through the pharmacovigilance system, that affect the benefit risk balance.
• That the medicinal specialty has a low risk of causing serious type A adverse reactions and a very low risk of causing serious type B adverse reactions in the general population.
• That does not possess genotoxic, carcinogenic or relevant reproductive toxicity properties.
• That it does not present interactions with commonly used medicinal specialties that could modify the therapeutic effect of them or generate serious adverse reactions.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

Yes, the delivery and sale of drugs, medicines and pharmaceutical products to the public can only be carried out in duly licensed pharmacies.

 

6. What health, advertising, and marketing claims may be made for OTC products?

See answer to Question 46 above.

 

7. Can OTC products be marketed or advertised directly to the public?

Yes. See answer to Question 20 of Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

That the medicinal specialty has been commercialized under the condition of sale under prescription in the country, at least during the last 5 years, without having presented reports of serious adverse events, through the pharmacovigilance system, that affect the benefit risk balance. This mechanism is regulated under ANMAT Regulation No. 3,686/2011.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

To import a pharmaceutical product (traditional medicine or OTC products) it is necessary to obtain the marketing authorization with ANMAT. Once a company is licensed as a pharmaceutical company with ANMAT, it will be allowed to apply for the marketing authorization certificates for manufacturing or importing products for sale in the Argentine market.

However, there are some main exceptional regimes for non-registered drugs, for example, national health programs carried out by the MoH and the exceptional regime for access to non-registered drugs (“RAEM” after its acronym in Spanish, also known as “compassionate use regime”). The RAEM regime regulates the procedure by which non-registered drugs can be imported by patients, under an individual basis, when an identical, similar or alternative therapeutic product is not available in the country, and by duly justified medical reasons sufficient for ANMAT to approve such import for a limited period of time (e.g., 90-day treatment).

 

Also from this Legal Handbook

Preclinical and clinical trial requirements in Argentina – a legal guide. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

No. It is not a condition for marketing approval to conduct a clinical trial in Argentina (the approval of pharmaceutical products based on similarity is allowed), provided that the applicant has the necessary preclinical and clinical data when filing the product application, depending on the type of drug (e.g., bioequivalence studies).

 

2. How are clinical trials funded?

Clinical trials may be either publicly or privately funded. Pursuant to local laws and regulations, the sponsor is the individual or legal entity responsible for the commencement, management and financing of a clinical trial.

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

At a national level, regulations set forth the good clinical practices for conducting clinical trials in human beings in the country and are harmonized with international regulations such as the Helsinki Declaration, Nüremberg Declaration, “Operational Guidelines for Ethics Committees that review biomedical research” (WHO-World Health Organization, 2000), the “International Ethical Guidelines for Biomedical Research in Human Beings” (CIOMS – Council for International Organizations of Medical Sciences, 2002), among many others. At a regional level, each province may have its own regulations.

Preclinical and clinical trials protocol requirements are set forth in MoH Regulation No. 1,480/2011 and ANMAT Regulation No. 6,777/2010. The protocols must be approved by ANMAT and by the intervening Ethics Committee.

According to national laws and regulation, the protocol must mainly comply with the following requirements:

• General Information: (a) full title of the study, including the phase of clinical development; (b) version number and date thereof; (c) name of the sponsor; (d) summary of the protocol; and (e) schedule of visits and procedures.
• Background and justification: (a) description of the problem to be investigated and current state of knowledge; (b) product information under investigation, including summary of the data of efficacy, pharmacokinetics, tolerance and toxicity obtained in clinical and preclinical studies; (c) purpose and relevance of the proposed research; and (d) basis for the development phase proposed for the study.
• Objectives: description of the primary and secondary objectives.
• Study design: (a) study design and justification of the choice; (b) random assignment method, if applicable; and (c) other methods to reduce bias.
• Population under study: (a) expected number of participants; (b) inclusion and exclusion criteria of participants; and (c) criteria for withdrawal of participants.
• Statistical analysis: (a) study hypothesis, specifying the null and alternative hypothesis; (b) specification of descriptive methods and statistical tests for variables; (c) criteria for the management of missing, excluded and spurious data; (d) criteria for inclusion or exclusion of participants in the analysis; (e) computer tools to be used; (f) criteria for the processing of security information; and (g) intermediate analysis schedule, if applicable.
• Efficacy evaluation: (a) parameters of effectiveness to be measured, including instruments and methods of measurement; and (b) effectiveness criteria.
• Products under investigation: (a) description of the products under investigation, indicating active pharmaceutical ingredient, formulation, dosage, way of administration, frequency and duration of treatment and follow-up; (b) allowed and not allowed medications; (c) criteria for suspension of treatment; and (d) planned rescue treatment and follow-up in cases of failure or events adverse.
• Adverse events: procedures for registering and reporting adverse events.
• Ethical aspects: (a) specification that the investigation will be reviewed by an Independent Ethics Committee (IEC); (b) procedures for obtaining informed consent; (c) protection of the confidential information and the identity of the participants; (d) details of coverage and compensation for damages available to participants; (e) justification of payments or compensation for expenses available to the participants; (f) anticipation of access at the end of the trial to the intervention identified as beneficial in the trial or to an appropriate alternative or other suitable benefit; (g) justification for the use of placebo, if used; (h) justification for carrying out the investigation in a vulnerable group, if applicable; and (i) possible conflicts of interest.
• Administrative aspects and others: (a) procedures for the conservation and storage of products under investigation; (b) registration and communication of clinical data; (c) handling of the trial documents; (d) monitoring and audit procedures; (e) criteria for the cancellation of the trial; and (f) plan for publication of the results.

 

4. What are the requirements for consent by participants in clinical trials?

The decision of an individual or his representative to participate in an investigation must be voluntary and free of undue influence, undue incentive or coercion. To make a decision, each potential participant or their legal representative must receive clear and precise information about the purpose, procedures, benefits and foreseeable risks and funding sources of the clinical trial. Participants have the right to access and rectify their data and to refuse to participate or to leave the study at any time, without any justification and without exposing themselves to any reprisal. After verifying that the individual or his representative has understood all the information, the principal investigator must request the informed consent.

The Principal Investigator should provide an opportunity and enough time for the potential participant or their representative to consider all the options, ask the questions they want and stay satisfied with the answers, and then verify through questions that they have understood all the information received.

After the information process has been completed, the participant or their representative in the cases provided by law, the Principal Investigator and the witness, when appropriate, must sign and date two originals of the consent form, as a statement of having received the information and having taken the free and voluntary decision to participate in it. The participant or their representative must receive one of the originals of the consent form and a copy of the information section.

 

5. May participants in clinical trials be compensated?

Yes. However, such payments must not be unbalanced to persuade the patient to run unnecessary risks (constituting an undue incentive). The intervening Ethics Committee must review and approve any financial agreement or payment to the participants.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

The sponsor must ensure coverage of medical care and contracting of insurance or the establishment of another type of guarantee in the country, in case of damage caused to the participants by the study. Likewise, sponsor must reimburse all subject injuries caused by the drug or study.

Also from this Legal Handbook

A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The National Ministry of Health (“MoH”) is the main health authority in Argentina. Nonetheless, in the year 1992, the National Agency of Medicines, Food and Medical Technology (the “ANMAT”, after its acronym in Spanish) was created by Decree No. 1,490/1992 (amended and complemented by Decree No. 1,271/2013). The ANMAT is an independent government agency and is granted jurisdiction to control the safety, efficacy, and quality of medicines and to control the activities, processes, and technologies performed for the supply, production, manufacturing, fractioning, import, export, warehousing and commercialization of products and materials used for human medicine.

ANMAT is also the national health authority in charge of registering and/or granting authorization to the persons and companies involved in the supply, production, manufacturing, fractioning, importation, exportation, warehousing and commercialization of pharmaceutical products and medical devices, and controlling the execution of such activities.

In addition, each province has its own health authority that works jointly with ANMAT, and can issue regulations.

Under the scope of the MoH, the Superintendence of Health Services (the “SSS” after its acronym in Spanish) has monitoring, control, and enforcement capacities over healthcare insurance providers of the National Health Insurance System and has authority over the national healthcare insurers’ providers and the National Institute of Social Security for Retired Persons and Pensioners. At a provincial level, the SSS does not have regulatory authority over the provincial healthcare insurance providers.

The National Comprehensive Drug Policy Department (the “SEDRONAR” after its acronym in Spanish) is the national agency acting on behalf of the Argentine Executive Branch that controls all operations involving certain chemical substances capable of being used in the illicit manufacture of narcotic drugs and psychotropic substances. The activities of production, manufacturing, preparing, repackaging, distribution, commercialization as wholesale or retail, storage, import, export, transport, transship and/or performance of any other type of transaction involving both nationally and internationally  the substances included in lists I, II and III of Annex I of Decree No. 593/2019 can only be performed upon the prior authorization and control of the National Registry of Chemical Precursors (the “RENPRE”, after its acronym in Spanish), dependent on SEDRONAR.

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

Pursuant to Law No. 16,463 (Law on Medicines), the import and commercialization of medicines and medical devices can only be carried out upon the prior authorization and under the control of the ANMAT.

The main national regulations concerning registration of pharmaceutical products (pharmaceutical products and biological drugs) and medical devices include the following:

PHARMACEUTICAL PRODUCTS

• Law on Medicines (as amended and complemented) regulates (i) the activities of production, manufacturing, import, export, fractioning, commercialization, and storage of medicines, chemical products, reactives, pharmaceutical forms, medicines, medical devices, diagnostic devices, and any other product for use or application of medicine on human beings, and (ii) whoever participates -individuals or corporations- in such activities, that can only be performed with the prior authorization and control of the health authority, in premises duly licensed and managed by a technical director duly appointed with the health authority.
• Executive Decree No. 150/1992 (as amended) applies to the registration, manufacturing, fractioning, prescription, sale, marketing, export and import of medicines. It also provides that as long as the product whose marketing approval is sought has been approved in any of the countries included in Annex I of the Decree, any person may apply for marketing approval without time limitations, submitting minimum information (bioavailability data and a project of label, leaflet and prospect). The list of countries includes, inter alia, Denmark, Japan, the U.S.A., Germany, the U.K., Spain, Italy, and France.
• ANMAT Regulation No. 5,755/1996 (as amended) complements Executive Decree No. 150/1992 and regulates the proceedings to register medicines before the health authority providing different pathways for filing the application form.
• Decree No. 1,299/1997 also regulates the Law on Medicines. This Decree set up the rules for the supply chain of medicines, requiring being prior and duly authorized by the health authority to engage in such activities. Pharmaceutical laboratories must only commercialize their manufactured or imported products (medicines), by themselves or through their distributors, exclusively with pharmacies, drugstores and/or public or private sanitary or healthcare establishments, duly authorized by the corresponding health authority. All medicine products should comply with the legal requirements regarding labelling, packaging, safety requirements, etc., prior to being commercialized.
• The authorization for commercialization approval granted by the health authority with respect to each product should be obtained in order to be allowed to market the product in the country, by correctly passing the “first batch technical inspection” at the facilities of the pharmaceutical company.
• ANMAT Regulation No. 7,075/2011 establishes the requirements and demands for the registration of biological medicines, including the medical specialties of biological origin for human use; industrially manufactured or manufactured with intervention of an industrial proceeding, such as hemoderivatives; products obtained by means of recombinant DNA; monoclonal antibodies; drugs obtained from biological flows or animal tissues; and other biological products.
• The registration of a biological product with the ANMAT requires the submission of a dossier that must include details of the manufacturer and holder of the certificate of registration of the product, quality information, pre-clinical and clinical information, and a plan for post-marketing surveillance.
• ANMAT Regulation No. 3,397/2012 approved the specific requirements for the authorization of biological drugs and/or monoclonal antibodies obtained from recombinant DNA methods. Those requirements are considered complementary to the ones provided by ANMAT Regulation No. 7,075/2011.
• The registration proceeding for biosimilars is provided by ANMAT Regulation No. 7,729/2011. These drugs are defined as biological drugs whose qualitative-quantitative composition, therapeutic indication, and proposed administration have backgrounds in other biological drugs registered with the ANMAT or by any foreign health authority (biological reference medicine or comparator), of which there is evidence of effective commercialization and sufficient characterization of its risk-benefit profile.
• Law No. 26,689 (rare diseases) seeks to promote integral healthcare of people with rare diseases (diseases whose prevalence in population is equal to or less than one in 2,000 people in relation to a national epidemiological situation). It also establishes that the social security sector (“obras sociales”), private healthcare insurance providers (“empresas de medicina prepaga”), and any other healthcare insurance provider must give healthcare coverage to patients with this condition, including at least those benefits determined by the competent authority.
• ANMAT Regulation No. 4,622/2012, as amended and complemented, regulates drugs or medicinal specialties aimed at preventing, diagnosing and treating rare or serious diseases for which there is no secure or effective treatment available (orphan drugs). It sets out the conditions for registering orphan drugs that will be assigned to the category of products authorized under special conditions. The granting of the product registration and the validity term of the marketing authorization certificate will be made by the competent authority on a case-by-case basis taking into account, among other things, the specific characteristics of the involved drug, the complexity of the disease to be treated, and information related to the phases of its development. The labels, leaflets and all information made available for professionals must include the legend “authorized under special conditions” (“autorizado bajo condiciones especiales”), with the same size and highlighting as the brand name and the Argentine Common Denomination or the International Common Denomination.

 

MEDICAL DEVICES

• Law on Medicines;
• ANMAT Regulation No. 2,319/2002 as amended and complemented, sets forth the requirements for a company to be holder of marketing authorization certificates and to commercialize medical devices;
• ANMAT Regulation No. 2,318/2002 as amended and complemented, defines what types of medical devices can be registered depending on the intrinsic risk for human health;
• ANMAT Regulation No. 9,688/2019 as amended and complemented sets forth the requirements for the registration of medical devices at the National Registry of Manufacturers and Medical Devices as well as the necessary documentation to be submitted in case of modifications to the marketing authorization certificates already issued by the health authority.
• Medical devices are classified for registration purposes in different classes (I, II, III, and IV), depending on the intrinsic risk for human health. For example, medical devices to be implanted in the body are included in Class III or Class IV, depending on their intrinsic characteristics. Instruments (intended to integrate and complement the medical device) are classified and registered separately from the medical device they integrate.
• ANMAT Regulation No. 2,674/1999 sets forth the general requirements for the registration of in vitro diagnostic medical devices at the National Registry of Manufacturers and Medical Devices. In addition, it was recently issued ANMAT Regulation No. 2,198/2022, which amends and complements ANMAT Regulation No. 2,674/1999 and will come into force on June 24, 2022. ANMAT Regulation No. 2,198/2022 provides the necessary documentation to be submitted in order to register, modify, transfer and cancel the registration of national and imported in vitro diagnostic medical devices, and classifies in vitro diagnostic medical devices into Groups A, B, C or D, depending on the intrinsic risk for the human health.

 

REIMBURSEMENT

• SSS Regulation No. 1,200/2012 as amended and complemented, sets forth the Unique Reimbursement System (“SUR”, after its acronym in Spanish) which is intended to financially support Health Insurance Agents in the reimbursement of certain treatments of low incidence, high economic impact and/or long-term treatment. The reimbursement mechanism can vary according to the type of healthcare insurance provider (public, social security of private), the particularities of the case, etc.

Since 2014, the ANMAT has issued regulations aimed at compelling the holders of marketing authorization certificates to report the suggested price of sale of their products, in order to publish such reference prices on its website in the National Vademecum of Medicines.

In the context of the COVID-19 pandemic, the MoH and the Secretary of Trade issued a Joint Regulation setting maximum prices for institutional sales to the health agencies of the public, private and social security subsystems throughout the country, for a limited period. The products involved were some relevant drugs used for the treatment of high-risk COVID-19 patients. It is likely that this measure or similar ones will be extended throughout the sanitary emergency.

 

3. What are the steps to obtaining authorization to develop, test, and market a product?

Any company that intends to directly commercialize and market medicines and/or medical device products in Argentina must first be duly licensed as a pharmaceutical and/or medical device company by ANMAT to manufacture or import/export medicines/medical devices. Once the company is licensed as a pharmaceutical/medical devices company it will be allowed to hold the marketing authorization certificates of the products for manufacturing or importing products for sale in the Argentine market.

 

4. What are the approximate fees for each authorization?

The costs for obtaining the license to commercialize pharmaceutical products and medical devices in Argentina would mainly consist in the fees to be paid to ANMAT for requesting the authorization to act as a pharmaceutical and/or a medical devices company and to obtain the marketing authorization certificates of the products. These fees vary depending on the type of product to be registered (i.e., synthetic, biological, orphan medicines, etc.). The fees are updated every year by ANMAT.

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Each pharmaceutical product (medicine) or medical device product requires being previously authorized by the health authority for manufacturing or import purposes and -as an evidence of such authorization- a marketing authorization certificate should be issued per product (“MAs”). MAs have a valid period of five (5) years, being able to be renewed for the same period. Registrations of orphan drugs have a specific validity term that is defined on a case-by-case basis by ANMAT.

 

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

ANMAT approves drugs on a similarity basis. Biological drugs including monoclonal antibodies obtained from recombinant DNA methods and biosimilars have a specific regulatory pathway for obtaining product approval.

There are no substantive differences between local and foreign-owned manufacturers. However, it should be noted that the MoH together with the Secretary of Trade have issued a joint regulation regulating the mandatory coverage of certain high-costs medicines by public and private healthcare insurance providers by giving preference to locally manufactured products available in the market with the same active ingredient or biosimilar than the products manufactured abroad, provided that their final sale price is significantly lower than the average price of the similar/biosimilar foreign manufactured medicines.

The Executive Decree No. 150/1992 sets forth the requirements applicable to several possible registration scenarios (e.g., depending on whether a similar drug to the one to be registered has already been authorized by the local authority or not, depending on the countries where the drug has been authorized, depending on whether the drug will be imported or locally manufactured, etc.).

ANMAT Regulation No. 5,755/1996 (as amended) complements the Executive Decree No. 150/1992 and regulates the proceedings to register medicines before the health authority providing different pathways for filing the application form. Regarding “similarity,” ANMAT Regulation No. 5,755/1996 sets forth the following definitions:

1. Similar medicinal or pharmaceutical specialty: the one that contains the same active pharmaceutical ingredients, the same concentrations, the same pharmaceutical form, same form of administration, same therapeutic indication, and same dosage being equivalent to the reference product and can differ in characteristics such as size, form, excipient components, lifetime period, and primary package.
2. Similar Pharmaceutical form: the one that is found in the same physical form (solid, liquid, gaseous), has the same form of administration and is equivalent to the pharmaceutical form of the reference product.

Therefore, as a practical matter a generic competitor may obtain marketing approval quite easily without submitting a complete registration dossier.

ANMAT Regulation No. 3,185/1999, as amended and complemented, provides a list of the medicines that require bioequivalence studies to be approved. Bioequivalence studies are thus, only compulsory for the medicines included in such list.

ANMAT Regulation No. 3,185/1999 also provides that bioequivalence studies are performed through a proceeding in which the generic drug is compared with a product (i.e., a reference product) that ANMAT has selected to perform the bioequivalence study so as to establish its interchangeability.

In principle, the reference products selected for performing bioequivalence studies are the leading products in the market.

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

Combination of medicines must obtain the corresponding MA with ANMAT.

The combination of medicines and medical devices is regulated under ANMAT Regulation No. 7,446/2019. This Regulation defines Combined Products as any product consisting of two or more components regulated by different departments of ANMAT, such as medicines and medical devices, which combined, constitute a sole entity. According to this Regulation, the “main mode of action” shall determine whether the Combined Product will be considered a medicine or a medical device product. For those products whose main mode of action is that of a medicine, the Regulation states that they will be registered as a Combined Product with the Registry of Medicinal Specialties within ANMAT. This Regulation does not include the Combined Products that have as the “main mode of action” that of a medical device product. Nevertheless, ANMAT Regulation No. 2,318/2002 provides that medical devices can incorporate a substance that, if used independently, could be considered a medicine and that such medical devices should be classified as a Class IV product.

The combination of two or more medical devices products is regulated by ANMAT Regulation No. 2,318/2002, as amended and complemented. If a medical device is intended to be used in combination with another medical device, the classification rules (Class I, II, III and IV) shall apply to each of the products separately.

 

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Administration or the European Medicines Agency expectations and requirements?

The MoH and ANMAT are mainly responsible for supervising pharmaceutical activities. Other authorities can also intervene depending on the jurisdiction where the activities are carried out: for example, the relevant municipality or provincial MoH where the pharmaceutical activities are being developed.

Compliance with the regulations is monitored by means of inspections, sample testing, traceability systems for pharmaceutical products and prohibitions by the health authorities.

In the framework of a Pan American Health Organization (PAHO) initiative to promote the recognition of Drug Regulatory Authorities, ANMAT´s evaluation process finished on December 11, 2009. PAHO fosters this WHO initiative in the Americas by carrying out evaluation processes led by experts. Countries submit themselves to the evaluation processes voluntarily. After exhaustive consultation and approval procedures, all the American countries agreed upon the election of an evaluation tool comprising all the regulatory functions an Authority should perform and the indicators proving its compliance. The first Drug Regulatory Authorities (DRA) that applied for an evaluation were: Chile´s ISP, Colombia´s INVIMA, Cuba´s CECMED and Argentina´s ANMAT. The evaluation performed on ANMAT was rated with a level IV certification, which is the maximum rating granted and which makes it the first National Reference Authority in Drugs Regulation in the region.

The regulatory regime can be comparable with the U.S. Food and Drug Administration or the European Medicines Agency with regards to expectations and requirements because all of them aim at similar objectives, that is to say, the health and safety of the population. Nevertheless, they do not have the same exact norms for regulating the pharmaceutical products, medicines and medical devices.

 

9. What is the potential range of penalties for non-compliance?

Penalties for non-compliance with the local regulatory framework will vary depending on the type and degree of infringement (e.g., potential risk for the health of patients, degree of intentionality, recidivism, unfair competition, etc.). There could be administrative, civil or criminal sanctions.

Except otherwise defined, infringements to pharmaceutical local regulations usually follow the penalties and/or preventive measures provided in the Law on Medicines No. 16,463, and Decree No. 341/1992 (or complementary regulations).

Violations to the Law on Medicines and/or its regulations are punishable with:

1. Warning;
2. Fines from ARS1,000 to ARS1,000,000 (Decree No. 341/1992 and ANMAT Regulation No. 1,710/2008);
3. Total or partial, provisional or permanent closure of the premises where the infringement was committed, depending on the seriousness of the violation involved;
4. Suspension or forfeiture of the business or professional license during a maximum term of three years or, in case of extremely serious offenses, permanent forfeiture of the license;
5. Seizure of the infringing products; and/or
6. Forfeiture of the license for selling and manufacturing the products.

The statute of limitations for the actions arising from the Law on Medicines is five (5) years. Such term will be interrupted in the event of committing any other violation to the Law or its complementary regulations (Section 24).

 

10. Is there a national healthcare system? If so, how is it administered and funded?

Yes. The Argentine healthcare system is divided into three sectors: public, social security, and private. These sectors overlap in membership, with some affiliates of the public sector or social security insuring themselves with private insurers as well, due to a shortage of certain services or the deficient quality of others. A health emergency plan is currently in effect due to social and economic factors which was issued prior to the COVID-19 pandemic. The response to this emergency includes an adaptation of the Mandatory Medical Program (“PMO” after its acronym in Spanish) to the available financial resources of the public and private healthcare insurance providers’ plans.

There is a variety of (federal, provincial, and municipal) laws and regulations in diverse fields such as social security, hospitals and procurement, the medical profession, as well as medicines and medical devices. Health is considered to be a social right with constitutional recognition; thus, Argentine legislation regulating medicines and medical devices primarily serves to protect public health.

• Public Sector

The public sector includes the national and provincial ministries, public hospitals (which also may provide services to people who are covered by public or private healthcare insurance providers), and primary healthcare entities, which provide assistance to the uninsured population. This sector is mainly financed through taxes. The public sector has been decentralized in recent decades, and the administration of national public hospitals has mostly been transferred to provincial and municipal governments.

 

• Social Security Sector

The Social Security Sector is operated by trade unions and covers all workers of the formal economy and their families. It is financed through mandatory payroll contributions from employees and employers (insurance schemes) and provides significant coverage within the Argentine health system.

Health-related social security includes national healthcare insurance providers (“OSN” after its acronym in Spanish) and the National Institute of Social Security for Retired Persons and Pensioners, under the jurisdiction of the national government. At a provincial level, social security consists of individual provincial healthcare insurance providers.

Each OSN must comply with the PMO. The PMO guarantees basic health coverage in the areas of preventive care, diagnosis, medical treatment, dental care and medicines. In 2002, due to the economic crisis and the financial problems of many funds, an Emergency Mandatory Medical Plan (“PMOE” after its acronym in Spanish) was implemented and still is in force (MoH Regulation No. 201/2002). The PMOE is mostly based on practices that are cost-effective and evidence-based.

 

• Private Sector

The private sector mainly includes all private healthcare insurance providers that offer health services (including private insurance agencies – pre-paid medicine companies). This sector is financed through voluntary contributions to private service providers, who generally search for larger and more efficient coverage. The private sector encompasses private health facilities. These providers must comply with the PMO which, as previously mentioned, guarantees coverage in the areas of preventive care, diagnosis, medical treatment, dental care, and access to medicines.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

The public sector coexists with the social security and the private sector, due to a shortage of certain services or the deficient quality of others.

 

12. Are prices of drugs and devices regulated and, if so, how?

So far, ANMAT has not issued specific regulations for fixing prices applicable to the products under its control.

However, ANMAT Regulation No. 5,039/2014, as amended and complemented, approved the on-line publication of the National Vademecum of Medicines (“VNM” after its acronym in Spanish), which contains the price of medicines. It should be noted that the price listed is based on the information provided by the owner of the MA.

In principle, the price of sale for each product indicated and published at the VNM would not formally imply a fixed price, and the MA holder would be able to negotiate the selling price of the product under its own criterion for each commercialization channel (institutional and/or through pharmacy channel).

Notwithstanding the lack of a more specific regulatory framework regarding pricing, be noted that there have been situations where the MoH fixed prices ad hoc for orphan drugs of high cost.

Also, in the context of the economic crisis and the COVID-19 pandemic, the MoH set maximum prices, for institutional sales, of some drugs used for the treatment of high-risk COVID-19 patients.

As from 2022, the Ministry of Health issues a monthly reference price list of certain medicines to establish the amount that healthcare insurance providers should at least cover (MoH Regulation No. 27/2022).

 

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

In most cases, drugs and medical devices are paid on an out-of-pocket basis and health coverage will depend on the PMO in force and the patient’s (private and/or public) healthcare insurance providers.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

The preparation of prescriptions and dispensation of medicines, including over-the-counter (“OTC”) and pharmaceutical specialties, whatever their condition of sale, can only be made in licensed pharmacies in the Argentine territory. The sale and delivery of such products in other places is deemed an illegal practice of the pharmacy. OTC and medicines sold under prescription must be personally dispensed at the counter by pharmacists or persons authorized to sell them. Any sale and dispatch outside these facilities is considered an illegal practice of pharmacy and, without prejudice to the sanctions established by law, offenders can be liable for violation of the Criminal Code.

However,  in August 2020, Law No. 27,553 on Electronic or Digital Prescriptions entered into force. This law provides that the prescription and dispensation of medicines, as well as any other medical or dental prescriptions or prescriptions from other legally authorized healthcare professionals to prescribe in the respective fields of healthcare and pharmaceutical care (public and private), may be written as electronic or digital prescriptions and signed with handwritten, electronic or digital signatures.

The commercialization chain of medical devices does not have a specific regulation, as it does with medicines. Please see Question 18 on Chapter about Marketing, Manufacturing, Packaging and Labeling Advertising, for further references.

The compensation is given as in any other commercial business, through the purchase and sale of the products and agreements within the commercialization chain (e.g., rebates, discounts, etc.).

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

Duly licensed professional pharmacists are the only responsible and trained persons for the duly dispense of medicines to the general public (Law on Generic Drugs). Pharmacy practice is only authorized to pharmacists with a valid degree (issued by a National/Private university entitled by the National Government), and duly licensed by the corresponding sanitary authority (Law No. 17,565, as amended, and local laws on pharmacy). It is mandatory for pharmacists to substitute the medicine prescribed by the physician for another medicine with a lower price (but same active ingredients, concentration, etc.) if the consumer/patient requests it. Pharmacists have similar obligations and prohibitions to those of the physicians, including jointly liability in the event of failing to supervise their auxiliary personnel activities.

It is mandatory for pharmacists to prepare or dispense prescriptions and supervise the fulfilment of the instructions delivered to their auxiliary personnel in order to observe the compliance of their acts are under the limits of his/her instructions. Pharmacists are jointly liable with their auxiliary personnel in the event of damage to third people due to insufficient and/or inadequate supervision of the activities performed by the auxiliary personnel.

 

Also from this Legal Handbook

Outlining the legal situation for marketing, manufacturing, packaging & labelling in Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.

 

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

See answers to Questions 2 and 3 in Regulatory, Reimbursement and Pricing Overview.

 

2. What is the authorization process for the marketing of generic versions of these products?

See answer to Question 6 in Regulatory, Reimbursement and Pricing Overview.

 

3. What are the typical fees for marketing approval?

See answer to Question 4 in Regulatory, Reimbursement and Pricing Overview.

 

4. What is the period of authorization and the renewal process?

See answer to Question 6 in Regulatory, Reimbursement and Pricing Overview.

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

Pharmaceutical companies must comply with local Good Pharmacovigilance Practices. Likewise, pharmaceutical companies must appoint a professional within its company who assumes connection functions with the health authority (through its Pharmacovigilance Department) to exchange information regarding adverse effects on medicines marketed by such pharmaceutical company.

 

6. Are foreign marketing authorizations recognized?

Yes, but only for product registration purposes (Argentina allows registration based on similarity, please see question 6 in Regulatory, Reimbursement and Pricing Overview above for more detail). Any product to be marketed in Argentina needs to previously obtain the relevant MA with ANMAT.

 

7. Are parallel imports of medicines or devices allowed?

Yes. The Argentine Supreme Court has accepted the validity of the so-called “parallel imports” in trademark matters. The Trademark Law does not include a specific provision for the “grey market” importation of pharmaceuticals. However, there is some old case law by the Argentine Supreme Court allowing parallel imports. This case law applies the so-called “international exhaustion” of rights.

Case law only refers to “parallel importation” of legitimate products. If the product is altered or if illegitimate products are imported, the trademark owner may seek injunctive relief with the Argentine Courts. If products are legitimate but substantially altered for sale in Argentina, the right holder could also have legal standing to object their import.

With regard to patents, the Patent Law also provides for an international exhaustion regime.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

The relationship between pharmaceutical companies and Healthcare Professionals (“HCPs”) is regulated and the regulation provides several ethical standards and guidelines that must be followed, particularly, on how the information to HCPs should be presented and how pharmaceutical companies should manage their relationship with HCPs without inducing them to prescribe their products, being thus motivated by non-ethical incentives instead of being the prescription a consequence of a professional decision based on scientific evidence. This regulation was enacted to tackle promotional practices that foster commercial circuits that jeopardize good practices for prescribing and that affect the rational use of drugs.

Promotional activities for prescription drugs are subject to the following principles:

1. the promotion of a medicine that has not obtained the corresponding MA is forbidden;
2. all the contents of the promotion of medicines are adjusted to the characteristic identifying data appearing in the MA; and
3. in any case, the promotion of medicines must favour their rational use, presenting them objectively within the framework of their pharmaceutical properties, therapeutic action and indications so approved (on-label). In this sense, the technical-scientific information necessary for the recipient to know about the therapeutic properties of the medicine must be provided.

Scope of the MoH Regulation No. 627/2007 is applicable to the:

1. promotion of medicines sold under prescription addressed to professionals licensed to prescribe or dispense medication;
2. promotional visits by sales reps, medical promotional agents or persons authorized by pharmaceutical companies, addressed to professionals licensed to prescribe or dispense medicines;
3. (supply of free samples, samples for professionals, samples without commercial value or similar samples;
4. sponsorship of promotional meetings where professionals licensed to prescribe or dispense medicines attend;
5. sponsorship of scientific conferences where professionals licensed to prescribe or dispense medicines participate;
6. incitement to prescribe or dispense medicines through the granting, offer, promise of monetary or in kind advantages, except when their intrinsic value is minimum; and
7. promotion, offer, commercialization of medicines made through web pages and/or electronic mails and/or in any other way over the Internet.
8. MoH Regulation No. 627/2007 prohibits the granting, offering or promising by the pharmaceutical companies and/or in their name and on their representation, of any kind of incentive or benefit such as premiums, monetary or in kind advantages or otherwise to HCPs and/or to persons related or close to them. Awards granted by pharmaceutical companies to the participants in the commercialization chain (distributors, drugstores and licensed pharmacies) are the only exception to this prohibition, when this is part of their commercial policy.

MoH Regulation No. 627/2007 prohibits the granting, offering or promising by the pharmaceutical companies and/or in their name and on their representation, of any kind of incentive or benefit such as premiums, monetary or in kind advantages or otherwise to HCPs and/or to persons related or close to them. Awards granted by pharmaceutical companies to the participants in the commercialization chain (distributors, drugstores, and licensed pharmacies) are the only exception to this prohibition, when this is part of their commercial policy.

This Regulation sets-up the basic framework applicable to: (i) the process for granting scholarships to HCPs and (ii) sponsorship of promotional/educational events. Section 16 aims to provide equitable and clear mechanisms, not based on prescription, for the selection processes of HCPs who apply for scholarships. Thus, to achieve the “equitable and clear mechanism” required by law, the proposed process should be based on objective standards (i.e., qualification, experience, etc.) and can never be based on the prescription of products. Considerations on the publication, terms and conditions, candidate selection process, scholarship reporting, etc., are issues that should be considered when drafting internal policies.

MoH Regulation No. 627/2007 does not distinguish whether a promotional activity is conducted under a scientific, educational, or strictly promotional event addressed exclusively to HCPs. The general principles established in said regulation are applicable for any event.

In regard to the promotion and advertising of medical devices intended for professional use only, it is not yet regulated in Argentina (there is a legal gap). Therefore, it cannot be specified which modes of advertising are expressly permitted when it comes to medical devices intended for professional use only.

There is a legal gap regarding the relationship between medical devices’ companies and HCPs; thus, it would be advisable to consider the ethical standards of MoH Regulation No. 627/2007 to be used as practical guidelines for the medical devices industry, under a conservative approach.

Finally, also consider that the pharmaceutical and medical devices industry relies its common practices on rules contained in its applicable code of ethics, enacted by the local industry chamber to which the company is a member. However, it is important to highlight that those chambers are not a government agency and, thus, only its members must comply with its code and the rules under such codes of ethics are, inter alia, not regulations in force (i.e., any defence argument grounded on such internal codes could be dismissed by the health authority and courts).

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The manufacturing of medicines and medical devices products are both regulated by ANMAT.

ANMAT Regulation No. 2,819/2004 -as amended and complemented by ANMAT Regulations No. 3,602/2018, 3,827/2018 and 1,281/2019, set forth the Guidelines for Good Manufacturing Practices for manufactures and importers/exporters of medicines -“GMP”.

The GMPs are applicable to manufacturing operations of medicines in all of its definitive pharmaceutical forms, including big-scale processes at hospitals and preparation of supplies for use at clinical trials. “Manufacturing/production” is defined as all the operations of acquiring materials and products, manufacturing, conditioning, quality control, release, warehousing, distribution of pharmaceutical products, and the controls related to it. “Manufacturer/Producer” is defined as the facility authorized to perform such operations (e.g., manufacturing, conditioning, and labelling of pharmaceutical products). The activities must be performed at a designated facility duly authorized and under the management of an authorized technical director. A quality control director should also be appointed to control and guarantee compliance. The guidelines of Good Manufacturing Practices and Good Quality Control Practices issued by the World Health Assembly (in May 1992) have been adopted in these regulations. Infringements of any of these obligations trigger the sanctions set forth in the Law on Medicines.

On the other hand, ANMAT Regulation No. 3,266/2013 provides the Good Manufacturing Practices for medical devices products.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

The mutual recognition agreement between the European Union (EU) and the United States (US) to recognize inspections of manufacturing sites for medicines conducted in their respective territories has progressed as planned, and it is now operational (with the exceptions of some products such as veterinarian products or products intended for use in clinical trials). The agreement aims to reduce duplicate inspections and allows the EU and FDA authorities to focus on manufacturing facilities outside the United States or Europe that are considered to be at higher risk. We consider that it may take a long time for the FDA and the EMA to recognize the inspections of Argentina plants, and in this sense, to recognize the GMPs requirements in Argentina as compatible with the FDA and EMA ones.

 

11. What is the inspection regime for manufacturing facilities?

ANMAT is allowed to make on-site inspections at any time, with or without prior notice, to inspect premises and verify compliance with the local regulatory framework. Good manufacturing practices, stability, and labelling standards and all other applicable provisions must be complied with. The legal inspection regime for medical device products is set forth in ANMAT Regulation No. 3,265/2013. On the other hand, the manufacturers of pharmaceutical products must comply with the GMPs set forth in ANMAT Regulation No. 2,819/2004, as amended.

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

The FDA and EMA are allowed to perform inspections in the local manufacturing facilities. In the case of the Mercosur, the State Parties may coordinate with the ANMAT to conduct a joint inspection if deemed necessary, according to ANMAT Regulation No. 3,264/2013 for pharmaceutical manufacturers and ANMAT Regulation No. 3,265/2013 for medical devices manufacturers.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Medicines must be stored in licensed premises with controlled environmental conditions, for them to maintain their properties. It is important to protect medicines from sun exposure, for example. If the deposit has windows, these must have some protection system (curtains, painted glass or to be covered with paper) to avoid the heat affecting the medicines directly.

The place must have a uniform temperature, less than 86° Fahrenheit, since above this temperature the expected effect of the drug could diminish. The storage place must not be damp. The place must not have leaks or filtrations, the floor’s grilles must be covered. Floors and shelves must be cleaned with damp rags to avoid dust.

The use of aerosols and sprays to disinfect or scent the air is prohibited. The presence of infestations like insects and rodents must be combatted. Gel products must be used and baits must be correctly identified. The presence of domestic animals (dogs, cats, birds) must be avoided, since they are a potential source of infestations (fleas, ticks, lice). Medicines must be ordered in shelves and never directly on the floor. A space between the last box and the back wall’s shelf must be left to ensure correct ventilation.

The deposit must have an absolutely separate space (it can be a box) where the medicines that are not fit for use must be kept. It must be specifically clarified with posters that say “DO NOT TOUCH, MEDICINE NOT FIT FOR USE”. In this place the expired medicines will be stored. It is forbidden to eat inside the deposit because the food leftovers can attract insects (cockroaches and ants) and rodents.

Furthermore, it is required to comply with the specific storage conditions that feature in the product’s prospect, approved by the healthcare authority. Lastly, the medical devices or products for diagnosis for use in vitro that have been expired or rejected must be identified and separated in a duly identified area.

 

14. What information must be included in medicine and device labelling?

Section 3 of the Executive Decree No. 150/1992 (as amended and complemented), provides that labels must state the laboratory’s name, laboratory’s domicile, the name of the Technical Director, the name of the product and the generic name of the drug in the same size and lettering style, the pharmaceutical form, the expiration date, how the drug should be stored and the conditions for sale, the sequence of manufacturing and the wording “drug approved by ANMAT, certificate number XXX”.

In the case of medical devices, the packaging and labels must also be approved by ANMAT before placing the product on the market. According to ANMAT Regulation No. 2,318/2002, labels must state the following information in the Spanish language: Instructions for use in packaging (in exceptional cases, this information may not be included in the products of classes I and II), information for the use of the medical device product per unit (in the product or in the container), complementary information for the specificity of the product, corporate name and address of the manufacturer and importer, information strictly necessary so that the user can identify the product and the content of the container, if the word “sterile” is the correct one to use, the batch number preceded by the word “batch” or the serial number, as appropriate, manufacturing date and expiration date or expiration date, the specific conditions of storage, conservation and/or product handling, specific instructions for operations and/or use of the product, any warning and/or precaution that must be adopted, registration number of the medical device product, etc.

 

15. What additional information may be included in labelling and packaging?

The labelling and packaging can provide all the relevant information that the consumer may need to obtain the best use possible of the medicine or the medical device. They may include pictograms, icons, different colours and all those elements of design that help a better understanding of the information. They may also induce the user to consult with the physician and/or the pharmacist in the event of any doubt that arises from the use of the medication or medical device.

 

16. What items may not be included in labeling and packaging?

The label and packaging must not infringe the interests of public health and always be previously approved by ANMAT. It may not be disguised, misleading, indirect, subliminal, or unfair. Finally, it should not attribute to the product a therapeutic, nutritional, cosmetic, diagnostic, preventive quality, or of any other nature not expressly recognized or authorized by the ANMAT.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

ANMAT Regulation No. 4,980/2005 establishes the general principles for the promotion of medicines sold over the counter to the general public and medical devices that can be directly used by patients and/or non-professional users, among other products such as food, cosmetics, etc. Under this regulation, the promotion must ensure a proper use of the product, objectively showing its properties, without misleading purposes, and must provide true, accurate, and clear information. The promotion may not infringe the interests of public health. It may not be disguised, misleading, indirect, subliminal, or unfair. Finally, it should not attribute to the product a therapeutic, nutritional, cosmetic, diagnostic, preventive quality, or one of any other nature not expressly recognized or authorized by ANMAT.

Any advertising of medicines or medical devices products must:

1. not advertise in a misleading, indirect, disloyal or subliminal way;
2. not use messages that provoke fear or distress;
3. not assign therapeutic and/or diagnostic (or of any nature) properties or actions that have not been expressly recognized or authorized by the health authority;
4. not advertise products that require a prior marketing authorization of the health authority without such authorization; and
5. make all the scientific information included in any advertising available to the health authority.

It is forbidden to promote medicines sold under prescription to the general public (Law on Medicines No. 16,463 as amended, Decree No. 9,763/1964, and MoH Regulation No. 627/2007). The promotion of medicines sold under prescription should only be addressed to healthcare professionals licensed to prescribe or dispense medicines (physicians and pharmacists), and carried out only by means of scientific publications or events, under the guidelines of MoH Regulation No. 627/2007.

Local regulations only allow the promotion to the general public of those registered medical devices that can be directly used by patients and/or non-professional users (Section 9 of ANMAT Regulation No. 4,980/2005). Pursuant to Annex I of Regulation No. 4,980/2005 and Section 1 of former Ministry of Health and Environment Regulation No. 20/2005, any advertising of medical devices products must:

• Not advertise in a misleading, indirect, disloyal or subliminal way.
• Not use messages that provoke fear or distress.
• Not assign therapeutic and/or diagnostic (or of any nature) properties or actions that have not been expressly recognized or authorized by the health authority.
• Not advertise products that require a prior marketing authorization of the health authority without such authorization.
• Make available to the health authority all the scientific information included in any advertising.

All advertising of medical devices that by their intrinsic nature and indications can be used directly -or indicated for their direct use- by a patient and/or not professional user, must:

• Seek the appropriate use of the product, describing its properties and characteristics without deception, providing accurate, truthful and clear information.
• Include the commercial name of the product.
• Include the wording “READ THE INSTRUCTIONS CAREFULLY. CONSULT YOUR DOCTOR IF YOU HAVE ANY DOUBTS” and comply with some specific rules, basically, for easy reading and comprehension by patients.
• Comparative advertising must not: (a) create confusion with the comparison; (b) belittle another product; (c) distort the image of another product; (d) undermine the name and/or reputation of third parties; (e) try to create a rejection situation towards the competitors’ products or its users.
• Unless being authorized by the relevant authority and depending on the risk of the product, only physicians, dentists, pharmacists, and authorized public government entities can dispense free samples to the general public.
• Advertising may include a telephone number or website for consultations, provided that the available information complies with the provisions of ANMAT Regulation No. 4,980/2005.
• The advertising through internet and any non-traditional advertising must comply with all the provisions of Annexes I and VII of ANMAT Regulation No. 4,980/2005.

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Virtual drug distribution is not allowed in Argentina. The delivery of medicines to any domicile or any type of direct or indirect delivery of medicines to the general public or establishments not authorized for such purpose, including the sale via post office, electronic, telephone, internet or any other modality that can be considered different to the activities granted by the company’s registration, is expressly prohibited.

The delivery and sale of drugs, medicines and pharmaceutical products to the public can only be carried out in duly licensed pharmacies. The sale and delivery of such products in other places is deemed an illegal practice of pharmacy.

The commercialization chain of medical devices does not have a specific regulation, as it does with medicines. In this sense, medical devices can only be marketed by companies duly licensed and controlled by the health authority.

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?

All the advertising made online for OTC medicines and medical device products that can be directly used by patients and/or non-professional users must comply with the provisions of ANMAT Regulation No. 4,980/2005.

In the case of prescription medicines, the promotion made through websites and/or in any other way over the Internet can only be addressed to healthcare professionals provided that the provisions set forth in MoH Regulation No. 627/2007 are fulfilled.

 

20. May medicines and devices be advertised or sold directly to consumers?

Medicines

Only the promotion of OTC medicines can be directly advertised to consumers provided that the requirements and conditions set forth in ANMAT Regulation No. 4,980/2005 are met. The promotion of medicines sold under prescription to the general public is forbidden.

Basically, any promotional activity of prescription medicines is subject to the following principles:

• The promotion of a medicine that has not obtained the corresponding MA, and the authorization for commercialization, is prohibited;
• All contents of the promotion of medicine must be adjusted to the identifying data approved in the MA (off-label promotion is forbidden); and
• The promotion of medicines must favor its rational use, presenting them objectively within the framework of their pharmaceutical properties, therapeutic sphere, and indications so approved (on label).

The technical-scientific information necessary for the healthcare professional recipient to know about the therapeutic properties of the medicine must be provided. It is mandatory for pharmaceutical companies to comply with MoH Regulation No. 627/2007, and to:

• Ensure that the promotion activities of prescription products adjust to the abovementioned dispositions;
• Verify that all medical advertising agents, sales reps and/or persons authorized by laboratories receive adequate information and training and comply with all the obligations established under this Regulation;
• Keep records on file for at least two years for each one of the promotional materials used and their bibliographic records that may be required by the health authority; and
• Provide to the health authority with the necessary information as requested.

The delivery and sale of drugs, medicines and pharmaceutical products to the public can only be carried out in duly licensed pharmacies.

 

Medical Devices

Local regulations only allow the promotion to the general public of those registered medical devices that can be directly used by patients and/or non-professional users. Advertising of medical devices must comply with the ethical criteria set forth by ANMAT.

The promotion and advertising of medical devices intended for professional use only is not yet regulated in Argentina (there is a legal gap). Therefore, which modes of advertising are expressly permitted when it comes to medical devices intended for professional use only cannot yet be specified.

However, under a reasonable interpretation of our local regulations, it could be construed that any promotional activity related to a medical device intended for professional use only and addressed to healthcare professionals should: (i) be made in compliance with the information contained in the MA granted by the local health authority; and also (ii) follow the rules contained in ANMAT Regulation No. 4,980/2005 as may be applicable for the healthcare professional recipient.

 

21. How is compliance monitored?

ANMAT uses an automatized system to control in real time any advertisement of medicines sold over the counter (among other products) directed to the general public.

Companies holding MA of medicines sold under prescription must notify ANMAT of the promotion related to such products (ex-post).

 

22. What are the potential penalties for noncompliance?

Any infringement to the Law on Medicines or its regulations would make the holder of the publicized product liable for the penalties provided by the Law on Medicines No. 16,463. Infringements to the Law on Medicines or its regulations can be punished with:

• Warnings.
• Fines from ARS 1,000 to ARS 1 million (Decree No. 341/1992 and ANMAT Regulation No. 1,710/2008).
• Total or partial, provisional or permanent closure of the premises where the infringement was committed, depending on the seriousness of the violation.
• Suspension or forfeiture of the business or professional license for a maximum of three years or, for extremely serious offences, permanent forfeiture of the license.
• Seizure of the infringing products.
• Forfeiture of the license for selling and manufacturing the products.

The statute of limitations for actions arising from the Law on Medicines is five years. This term is interrupted if another violation to the Law on Medicines or its complementary regulations is committed.

Any violation of Executive Decree No. 274/2019 (Fair-Trading Decree) will be punished with the following penalties:

• Warnings.
• Fines from ARS 40.61 to ARS 406,100,000 (updated every year).
• Suspension for up to five years from listing on the providers’ registers of those who can contract with the state.
• Loss of concessions, privileges, tax or credit benefits.
• Total closure of the premises for a maximum of thirty days.

Any infringement to the Law No. 24,240 (Consumer Protection Law) will be punished with the following penalties, jointly or independently:

• Warnings.
• Fines from ARS 83,45 to ARS 834,500,000 (updated every year).
• Forfeiture of the products under infringement.
• Closure of the premises or suspension of the services for up to 30 days.
• Suspension for up to five years from listing on the providers’ registers of those who can contract with the state.
• Loss of concessions, privileges, tax or credit benefits.
• Publication of the sanction in a recognized newsletter of the place where the infringement took place.

Any infringement to the Law No. 17,565 (Law for the Pharmacy Practice, as amended), and/or its regulations may be punished with the following:

• Warning;
• Fines from ARS 1,000 to ARS 1 million (Decree No. 341/1992 and ANMAT Regulation No. 1,710/2008);
• Total or partial, provisional or permanent closure of the premises where the infringement was committed, depending on the seriousness of the violation involved or in case of recidivism;
• Suspension or forfeiture of the business or professional license during a maximum term of three years;
• Seizure of the infringing products; and/or
• Forfeiture of the license for selling and manufacturing the products.

 

Also from this Legal Handbook

The COVID-19 pandemic has caused economic and social disruption and has affected the behavior of both consumers and producers in Argentina, with an important impact on Argentine currency (ARS) devaluation and inflation, among others. We are not yet able to measure the real impact of the uncertainty the world is currently facing, and its impact on the country.

 

In December 2019,  the National Government implemented agreements with key sectors, such as that with the local pharma association, and enacted emergency legislation such as Law No. 27,541, which declared, prior to the pandemic, a public state of emergency in economic, financial, fiscal, administrative, pension, tariff, energy, health, and social matters. Despite the public state of emergency in sanitary and health matters was extended up to December 31^st, 2022 (Decree No. 260/20, Decree No.867/21, and complementary regulation), several players in the pharma industry have successfully adapted, thrived and prospered under the current scenario.

 

Although emergency measures tightened once the lockdown was ordered in 2020, the current government implemented a set of policies including price controls, significant capital transfers from the public sector to individuals and certain companies, foreign exchange restrictions , and tax increases. Some government actions affecting the pharmaceutical industry have included setting maximum prices for certain innovative drugs which is unprecedented. As from 2022, the Ministry of Health issues a monthly reference price list of certain medicines to establish the amount that healthcare insurance providers should cover.

 

With regards to M&A activity, the pharmaceutical industry has managed to thrive in Argentina during the current crisis, with some relevant deals that took place, even, during the full lockdown, and others ongoing projects. Big global pharmaceutical companies are facing the re-structure of their mature and/or OTC portfolios in the LatAm region during this time, which has had interesting results for the local pharma industry in terms of regionally expanding their business portfolio. Other global pharma companies are restructuring their business model oriented to having a local footprint in the country.

 

According to the Industrial Production Index, measured by the Argentine Institute of Statistics and Censuses (INDEC, after its acronym in Spanish), pharmaceutical products registered a year-on-year increase of 8.5 percent in the reference month (December 2021).  As from 2021, the domestic demand of medicines and healthcare has increased thanks to the private and public sector. In fact, lockdown and strict restrictions on people’s mobility in 2020 postponed hospital care for non-COVID-19 illnesses (e.g., routine visits, screening, scheduled medical procedures, etc.) and also reduced the incidence of common winter illnesses. Consequently in 2021, the demand and prescription for various medicines increased as the government loosened restrictions.  What is more, the National Government has centralized the purchase of vaccines against COVID-19, and has recently fostered pharmaceutical public tenders, including those awarded under the “Remediar” program, among others.

 

Moreover, new opportunities are developing in areas such as clinical trials, gene therapy, medicinal cannabis, and telemedicine, due to recent changes in regulations. For instance, in January 2021, the Argentine Executive Branch finally implemented Law No. 27,506, which provides for a promotional tax regime for innovative companies related to the biotechnology, neurotechnology and genetic engineering, nanotechnology, and nanoscience industries. In this context, several provinces have adhered to this regime and have also implemented for these sectors a differentiated tax regime for provincial taxes. Consequently, foreign investments over US$ 300 million dollars are expected for the upcoming years in the country (mostly on clinical research).

 

Further investments are also expected as result of the new regulatory framework for the development of medicinal cannabis and industrial hemp. The regulation would develop not only the different segments of the medicinal cannabis chain (cultivation, harvesting, processing, marketing, etc.) but also the use of hemp in the textile, footwear, cosmetics, food, wood, and car industries, among others.

 

Foreign exchange regulations are constantly changing in Argentina, so it is of outmost importance to obtain adequate advise for an expert to properly design the best operating model for the entity in Argentina.

 

Against this backdrop, while some companies are divesting (often as a result of global policies regarding their mature products and to focus product pipeline on complex drugs), others have expanded their business by switching from a third-party full distributor model to a hybrid or even to a full affiliate model, by taking advantage of the reduced costs derived from the context, basically resulting from the economic crisis due to the devaluation of the national currency and continuous high inflation. This specific local dynamic calls for innovative buyers and sellers, who need tailored and well defined legal and regulatory strategies for navigating this process in a successful manner.

 

Under Argentine law, the buyer is responsible for auditing the target company and assumes all liability once the transaction is closed, except for usual indemnification based on representations and warranties granted by the seller. In addition, during the past few months, certain practices implemented by unions have also had an impact on transactions requiring the parties to discuss risk allocation based on potential actions that might be implemented by unions in the context of the deal. Hence, the ability of specialists to forecast future scenarios is of utmost importance, and due diligence processes must be conducted without losing sight of political and economic factors, as well as the legislative and regulatory activity relevant to foreign investments, the target, and merger control system. Additionally, the same skills are required if we refer to US-based SPAs (often used for agreements celebrated in Argentina), since this pandemic has evidenced how difficult it is for standard clauses (i.e., material adverse change and earn-out clauses) to overcome uncertainty and solve different issues such as large distortions in the valuation of assets. In consequence, change is needed in the way we draft certain provisions like reps and warranties, material adverse change or indemnity clauses, and how we define the procedures used to assess the value of the target, or what the parties will consider as the ordinary course of business, to name a few.

 

In conclusion, rapid fluctuations in several economic indicators, and the frequency of contractions of the business cycle have induced some companies to pull out of the country, but that volatility has also created incentives for other companies to stay or decided to have a local footprint and even to further invest by taking advantage of the current juncture. In that sense, the expertise of the pharma specialists involved in M&A operations is crucial in terms of timing, cost, and quality of the final transaction (especially when dealing with highly regulated industries such as pharma).

Also from this Legal Handbook

On October 27^th, 2019, presidential candidate Alberto Fernández was elected president of Argentina defeating the Macri Administration with more than 48% of votes. The key proposals of Fernández’s political campaign were based on socially-friendly reforms, such as helping the most vulnerable population to progress in the struggling economy, aiding the local industry and blue-collar workers, and ending with the increasing external debt and economic crisis. Another key element to the campaign was his political message promising everyone’s better access to the basic health services, vaccines and medicines.

 

Fernández’s four-year term of office started on December 10^th, 2019. Its administration has moved with significant speed to implement core reforms and agreements with key sectors, such as the local pharma association agreement in where they manage to lower medicine prices by 8%. Nevertheless, the most relevant and recent reform was the issuing of Law No. 27,541 of Social Solidarity and Productive Reactivation.

 

Law No. 27,541, published on December 23^th, 2019 in the Official Gazette, declared a public emergency in economic, financial, fiscal, administrative, pension, tariff, energy, health, and social matters. In addition, pursuant to article 76 of the Argentine Constitution, the Law delegates important legislative powers to the Argentine Executive (the “PEN”, after its Spanish acronym).

 

In connection with the health emergency declaration, Law No. 27,541 within the framework of Public Emergency strengthens the Ministry of Health’s regulatory powers and grants a wide range of options within which to act. The main aspects from a health perspective include:

• Health Emergency: The PEN is delegated with the possibility of: (i) ensuring the supply of medicines for outpatient treatments of patients in highly vulnerable social conditions, access to medicines and supplies for the prevention and treatment of non-transmissible infectious and chronic diseases; (ii) ensuring effective compliance with the law when it comes to the control of diseases that are prevented by vaccine; and (iii) ensuring that beneficiaries of the National Institute of Social Security for Retired Persons and Pensioners (“PAMI”, after its acronym in Spanish) and the National Health Insurance System have access to essential medical assistance provisions.

 

• PAIS Tax Exemption: All those expenses related to health benefits and purchase of medicines are exempted from the Tax for an Inclusive and Supportive Argentina (the “PAIS”, after its acronym in Spanish) (art. 36, subsection a).

 

• Ministry of Health Programs: The priority provided for some of the Ministry of Health Programs is maintained (e.g. Fight against HIV, Control and Prevention of Non-transmissible Chronic Diseases, etc.) (art. 64).

 

• Exemption from import duties: Vaccines and disposable items imported by the Ministry of Health and/or the PAHO Revolving Fund are exempted from import duties and any other customs, port taxes or tariffs (art. 73).

 

• National “Remediar” Program: The objective of developing a universal access to essential medicines through the National “Remediar” Program is restored (art. 76).

 

• Public healthcare insurance providers’ contracts: Suspends the restrictions that limit the public healthcare insurance providers’ freedom to contract with entities that have direct or indirect jurisdiction over the control of professional license or limit the right to contract directly to their members (art. 78).

 

• Suspension of Enforced Budget Implementations: Until December 31^st, 2020 forced implementations of credits and precautionary measures held by the Argentine State and the Argentine Tax Authority against public or private hospitalization, diagnosis and treatment healthcare facilities registered in the National Registry of Providers of the Superintendence of Healthcare Services (the “SSS”, after its acronym in Spanish), as well as against geriatric and rehabilitation facilities providing the PAMI are suspended (articles 79 and 82).

 

• Faculties granted to the Ministry of Health: (i) To establish a mechanism for monitoring the prices of medicines and supplies in the health sector and alternatives for direct imports and compulsory licenses in the event of availability problems or unjustified price increases affecting the population’s access to them; (ii) To issue supplementary legislation to implement: (a) list of medicines and supplies to be acquired by PAMI and the SSS, (b) reference prices of supplies and essential medicines by therapeutic band, and (c) controls and devices that promote the validity of Law No. 25,649 -Law on Generic Drugs-, and (iii) The agreements made within the framework of the health emergency can be made, apart from the valid ways of contracting, by any of the following modalities (a) direct contracting mechanism (art. 25, paragraph 5 of Decree No. 1023/2001); (b) use of resources from the PAHO/WHO Regional Revolving Fund for Strategic Public Health Supplies and the World Health Organization; and (c) other means offering alternatives through international organizations, multilateral agencies, non-governmental organizations or other countries (articles 70 and 71).

 

• Suspension: The right of beneficiaries of the National Health Insurance System to choose between a social security scheme or an entity whose purpose is to provide health services under the National Health Insurance System must be suspended for the duration of the health emergency in all matters that are contrary to this Law (art. 84).

 

Although this Law brings about tax benefits for the health industry and promotes the population’s access to health services, the real impact for the industry will be contingent on how the PEN and the Ministry of Health use their delegated powers, such as price, purchase and import controls. In addition, other less friendly measures were implemented, such as the partial suspension of Law No. 27,506 (Biotech Law) which provides for a promotional tax regime for many innovative companies, such as: biotechnology, neurotechnology and genetic engineering, nanotechnology and nanoscience industries. Law No. 27,506 was to become effective on January 1^st, 2020, but the Ministry of Productive Development Regulation N° 30/2020 suspended its implementation based on the grounds that a new regulation for the Biotech Law was needed.

 

It seems that the pharmaceutical industry will be immersed in several negotiation rounds with the Fernandez’s Administration for the next months and that prices, import controls, public procurements, investments and tax matters will be at the center of all negotiations.