The Pharma Legal Handbook: Ecuador

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Regulation, Pricing, Clinical Trials, Marketing, Manufacturing, Trademarks, Patents, Biosimilars, Orphan Drugs and more!

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Prepared in association with Corral Rosales, a leading Ecuadorian law firm.

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August 2018

1. Ecuador’s Emerging Cannabis and Hemp Industry

The cannabis and hemp industry is an emerging new industry in Ecuador with the Reform of the Criminal Law, enacted on June 21^st, 2020.

Included among the reforms is the decriminalization of possession of drugs containing cannabis or derivatives as their active ingredient for therapeutic, palliative, or medicinal use, or for the practice of alternative medicine. In addition, the Law of Control and Prevention of the use of Drugs has been amended, excluding non-psychoactive or hemp cannabis from control, extended to the cannabis plant or any part of the plant, whose delta-9-tetrahydrocannabinol (THC) content is less than 1% dry weight.

Based on the abovementioned Reform of the Criminal Law, the Ministry of Agriculture had 120 days to issue the regulations applicable to the agro-industrial activities around non-psychoactive cannabis and hemp in Ecuador; hence on October 19th, 2020, the Ministry of Agriculture issued the Ministerial Agreement No. 109-2020, which regulates the Import, Planting, Growing, Harvest, Post-Harvest, Storage, Transportation, Processing, Marketing and Export of Non Psychoactive Cannabis or Hemp and Hemp for Industrial Use. This Ministerial Agreement came in force upon its signing and execution. This regulation stablishes the requirements that have to be fulfilled in other to obtain the seven types of licenses, which authorize the following activities only regarding cannabis or hemp with a concentration of THC below 1%:

License for the Import and Commercialization of Non-Psychoactive Cannabis or Hemp Seeds or Cuttings, or Seeds of Hemp for Industrial Use.
License for the Import and Commercialization of Non-Psychoactive Cannabis or Hemp Seeds, or of Non-Psychoactive Cannabis or Hemp Cuttings, or Hemp Seeds for Industrial Use.
License for the Cultivation of Non-Psychoactive Cannabis or Hemp.
License for the Cultivation of Hemp for Industrial Use.
License for the Processing of Non-Psychoactive Cannabis or Hemp and Production of Non-Psychoactive Cannabis or Hemp Derivatives.
License for Plant Breeding and / or Germplasm Banks and Research.
License for the Acquisition of Non-Psychoactive Cannabis or Hemp Derivatives and / or Biomass or Flowers, or Hemp Biomass for Industrial Use, for Export.

On the other hand, this generated the need for the Ministry of Health (abbreviated as MSP in Spanish) and the Agency for Health Regulation, Control and Surveillance (abbreviated as ARCSA in Spanish) to accelerate the development of regulations applicable to finished products, since the Reform of the Criminal Law also opened the door to the production and import of finished product, which as defined in the Ministerial Agreement No. 109-2020, is:

Finished Product: Preparation obtained from the production of Non-Psychoactive Cannabis Derivatives or Hemp, to be marketed or distributed as a product for human or animal use or consumption and that has a sanitary registration, sanitary notification or the permit that applies according to the type of product based on the Ecuadorian regulations. Among them, but not limited to, are the following: processed foods, dried flower, beverages, food additives, food supplements, cosmetics, homeopathic products, medicines, medical devices, processed natural products for medicinal use and veterinary products.

Based on the above mentioned and considering how fast the industry moves, on February 25^th, 2021 the Agency for Health Regulation, Control and Surveillance (ARCSA) issued Resolution No. ARCSA-DE-002-2021-MAFG with the “Sanitary Technical Norm for the regulation and control of products for human use and consumption containing non-psychoactive cannabis or hemp, or its derivatives”, which came into effect the same day. This resolution allows the production, import and commercialization of the following finished products with the concentration of THC specified for each category:

Pharmaceutical products in general, processed natural products for medicinal use and homeopathic products (Pharmaceutical products that contain a concentration of THC equal to or greater than 1% in their formulation will be regulated as drugs subject to control.): Less than 1% THC;
Processed foods and food supplements: Less than 0.3% THC;
Cosmetic products: Less than 1% THC;
Medical devices, Hygienic Products for Industrial Use, Pesticides for Household Use, Pesticides for Public Health or Pesticides for Industrial Use, Household Hygiene Products and Absorbent Personal Hygiene Products: Less than 1% THC.

Considering how quickly the regulations moved, the Ministry of Health did not want leave anything out, therefor it gathered a group of experts and developed the regulation for the prescription, provision and therapeutic use of medicinal cannabis and pharmaceutical products containing cannabinoids and on March February 26, 2021 issued the Ministry Agreement No. 148-2021, which came into effect on March 15^th, 2021.

It is worth noting that the cannabis/hemp regulatory framework has moved quite fast in Ecuador and has opened the eyes of many local and international investors. The authorities are aware of what this industry can generate to the country in terms of research and investment, therefore, as long as the players comply with all the rules, they will be able to develop a myriad of products, since Ecuador, for now is the only country in the region that has showed so much openness; and as a consequence, it is expected that it may become a research and development cluster for cannabis and hemp products that will be sold all around the world.

Also from this Legal Handbook

2. The Use of Cannabis Has Been Approved in Ecuador

In the 1st Supplement of the Official Gazette No. 107 of December 24, 2019, the Reform of the Criminal Law was published, which will enter into force in June 21, 2020.

Included among the reforms, is the decriminalization of possession of drugs that contain cannabis or derivatives as their active ingredient for therapeutic, palliative or medicinal ends, or for the practice of alternative medicine. In addition, the Law of Control and Prevention of the use of Drugs has been amended, excluding non-psychoactive or hemp cannabis from control, extended to the cannabis plant or any part of the plant, whose delta-9-tetrahydrocannabinol (THC) content is less than 1%.

The Ministry of Agriculture will have 120 days from the entry into force of this law to issue the regulations to control the import, planting, cultivation, harvest, sale, industrialization and exportation of industrial hemp. Furthermore, shortly the National Assembly must approve the Health Law, in which cannabis and its derivatives for medicinal and therapeutic use will be regulated.

This article was first published on the Corral Rosales website here

Also from this Legal Handbook

3. Biosimilars and Biologics: Ecuador

Biosimilars and biologics in Ecuadorian pharma – a comprehensive legal overview. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

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

No, the generic term is used only for chemical synthesis medicines and the term biosimilar is used for medicines of biological origin.

The biosimilar medicine is similar in terms of quality, safety and efficacy to the reference biological medicine. It is necessary for a biosimilar medicine to demonstrate through its comparability exercise its equivalent capacity to the reference biological medicine.

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

All medicines are patentable, regardless of its nature, provided it meets the patentability requirements requested by current Laws (Andean Decision No.486 and local IP law)

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, in order to obtain the marketing authorization of a biosimilar, it is necessary to comply with Ministerial Agreement 385 “Reform and Codification of the Regulations for obtaining marketing authorizations, control and surveillance of biologicals for human use”

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?

The information necessary to obtain a marketing authorization of a biosimilar is similar to that of a biological one, with the difference that non-clinical studies are not necessary and clinical studies should be submitted as appropriate and must comply with the following:

Administrative information and prescription information.
Summaries of common technical documents.
Quality information.
Studies of physicochemical and biological characterization of the active pharmaceutical ingredient and the finished product.
Pharmacovigilance program (risk management plan).
Studies of non-clinical comparability of the biosimilar medicine compared to the reference biological medicine and should include at least:
- Toxicity
- Pharmacokinetic and pharmacodynamic studies in at least one suitable model in animals.
- Local tolerance test.
- Immunogenicity studies and reports of these studies according to the ICH guidelines.

The scope and magnitude of clinical studies will depend on the size of the residual uncertainty about the biosimilarity of the two products after performing a structural and functional characterization.

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

When choosing a reference biological medicine in a comparability study, the following considerations should be taken into account:

The reference biological medicine must have been marketed for at least one year, so that the demonstration of similarity with this product highlights a substantial amount of acceptable data regarding its safety and efficacy.
The manufacturer shall demonstrate that it is appropriate to support the application for authorization to market the biosimilar medicinal product.
Must have been registered on the basis of complete quality, safety and efficacy data.
Use the same reference biological medicine throughout the entire biosimilar medicine development process.

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

Yes, the reference biological medicine must be authorized and marketed by at least one of the countries whose drug regulatory agencies have been qualified by the Pan American Health Organization (PAHO), as Regional Reference Authorities, or hold a marketing authorization granted by Health Authorities of:

Usa
Canada
Australia
South Korea
UK
European Medicines Agency (EMA) process

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

The price regulation system is the same as that of a biological medicine, once the marketing authorization of the biosimilar medicine has been approved, the proceeding must be confirmed in the Technical Secretariat for the Approval of Prices for Drugs, who will determine if the price is regulated or free.

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

The return or refund policy does not exist in biosimilar medicines in Ecuador.

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

n/a

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?

The Health Law establishes that health professionals are the only ones authorized to prescribe prescription medications, regardless of their nature, whether they are chemical synthesis or biological. In public institutions the prescription will be mandatory according to the legally established protocols and treatment schemes.

The dispensing of biosimilar medicines will depend on the corresponding health risk, and may be found in establishments approved by the National Authority for the sale of these products (pharmacies).

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

No, the prescription of medications can only be given by a health professional, and will be said professional who determines the use of the medication in relation to the therapeutic information, as well as the scientific evidence of the product.

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?

No, they are the same as for biological medicines and the subsequent requirements once the health record is obtained are:

Price approval.
Post-registration control (sampling).
Records of adverse reactions and submission of periodic updated safety reports (PSUR)

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

No, they must comply with the labeling requirements of biological medicines and must include:

Secondary container:
- Name of the medicine
- International Nonproprietary Name, when applicable or name of the active substance when there is no INN
- Type of biological medicine (vaccine, blood products, processed and related products, biotechnology, biosimilar and other biological medicines)
- Concentration, potency or viral titer, as appropriate
- Dose
- Number of doses per vial (for multidose presentation), as appropriate
- Route of administration
- Lot number
- Qualitative quantitative formula in biological units with their equivalence in units of weight. Including excipients. It should be added where appropriate the INN of ingredients.
- Pharmaceutical Form of the product
- Package contents using the international system
- Temperature and storage conditions
- Solutions used to dilute where appropriate
- Preparation instructions and use instructions
- Name of the manufacturer, city and country of this laboratory
- In the case of products packaged by a third party other than the manufacturer, the name of each party must be declared, indicating their participation status
- Manufacturing and expiration date – health registration number o Modality of sale o General warning: “Delicate product. Administer by prescription and medical surveillance ”
- Additional warnings in accordance with the active substance (s) of the product
- If the product has been teratogenic, for any of the animal species contemplated in toxicological preclinical studies, the warning: “Contraindicated in pregnancy or when its existence is suspected”

Primary container (label)
- Name of the medication
- INN when applicable or name of the active ingredient when there is no INN
- Content expressed in the international system
- Dose
- Number of doses per vial (for multidose presentation), as appropriate
- Qualitative quantitative formula in biological units with their equivalence. Excipients can be excluded when the package is very small.
- Route of administration
- Manufacturer’s name
- Lot number or code
- Temperature and storage conditions
- Manufacturing and expiration dates
- If the product has been teratogenic, for any of the animal species contemplated in toxicological preclinical studies, the warning: “Contraindicated in pregnancy or when it existence is suspected”

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)

The only change has been that Ministerial Agreement No. 3344 “Regulations for obtaining marketing authorizations, control and surveillance of biologicals for human use” was repealed and replaced by Ministerial Agreement No. 385 “Reform and codification of the Regulations for obtaining marketing authorizations, control and surveillance of biologicals for human use”.

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?

No.

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4. Localization: Ecuador

A brief overview of the situation regarding localization in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

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?

Any new productive investments, including investments made on the pharmaceutical sector, that are initiated until August 2022, may benefit from tax exemptions. If the investment is located in Quito or Guayaquil, the entity will be exempt from paying corporate income tax for 8 years from the fiscal year it starts generating income. If the investment is located outside of Quito or Guayaquil, the entity will be exempt from paying corporate income tax for 12 years. Existing entities may also benefit from this exemption if new investments are made, on a proportional basis.

In addition, new investments may benefit from exemption of customs tariffs and foreign exchange tax and on the import of capital assets and raw materials.

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

The tax benefits applicable for new investments described above were established on August 21, 2018 and were extended for two additional years on August 19, 2020.

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)?

Localization has no effect.

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)?

Localization has no effect.

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)?

Localization has no effect.

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)?

Localization has no effect.

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?

Localization has no effect.

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

No, only those set out at point 1.

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?

The last legal reform affecting the relevant localization policies was in August 2020. There is currently no discussion as to new localization policies, and we do not consider that there would be any changes to these in the near future.

Recap Table

Country ECUADOR	Research	Clinical Trials	API Content	Fill and Finish	Packaging
Require/Benefit	B	B	B	B	B
Requirement
Benefits	Tx	Tx	Tx	Tx	Tx

Line 1
0 – if neutral
R – if a requirement B – if provides benefit

Line 2 and 3 Fill in (according to answer in Line 1)

MA – Market Access
P – Pricing
R – Reimbursement
T – Tenders
Tx – Taxes and import tarifs

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5. Orphan Drugs and Rare Diseases: Ecuador

The key facts about orphan drugs and rare diseases in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

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

Our law states a specific definition for rare diseases which is the following:

They are the ones that are mainly considered life threatening or that debilitate in the long term, with low prevalence and high complexity that constitute a wide set of disease. That are characterized by being chronic and disabling. Their therapeutic resources are limited and expensive, some are in the experimental stage.

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

Orphan Drugs. – Those listed in the CNMB (NATIONAL TABLE OF BASIC MEDICINES) are manufactured by biotechnology or by complex pharmaceutical technology processes, are sold at high prices, generally have only one manufacturer worldwide, are not sold as generics, and its supply is difficult.

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?)

National Agency for Regulation, Control and Sanitary Surveillance (ARCSA) is the regulating agency that establishes the requirements to authorize orphan drugs. The regulations that establish and regulate orphan drugs are:

Regulation of Sanitary Registration for Medicines in General
Instructions for the Treatment of Rare and Catastrophic Diseases
Technical Standard Import Medications, Specialized Treatments
Substitute technical regulations to authorize import by exception and import by donation drugs, biological products, medical devices and biochemical and diagnostic reagents
Replacement regulation to authorize the acquisition of medicines that are not included in the National Basic Medicines Chart – current CNMB.

There is a proceeding to authorize the import and commercialization of orphan drugs and recognize the authorizations in other countries; however, it is necessary to take into account so that in order for the regulatory authority to issue the corresponding permit it is necessary to evidence that the drug is necessary.

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

There are no provisions that establish requirements for clinical trials or scientific evidence for Orphan Drugs.

5. Is there an expedited pathway for Orphan Drugs?

The proceeding to import orphan drugs is quicker than that to import other drugs. The importation of the goods that have the authorization by exception (orphan drugs), must be made during the period of six (6) months following the issuance of the authorization from ARCSA (regulating entity).

This authorization will also be valid for partial shipments that due to their volume or nature require several shipments to complete the authorized import quantity, they will be covered by or referred to the same shipping document and in the same way must be imported within a period of six (6) months from the issuance of the authorization.

Once the authorization is granted, the applicant must notify ARCSA within a two (2) months term, the date and place of arrival or departure of the product, indicating its expiration date; batch or serial number (as applicable), invoice or other documents that the authority deems necessary, if not submitted with the initial application.

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

In the case of drugs for rare diseases or orphan drugs, our legislation requires that they have the respective health notification in force from the country from where originates from or from the country where it is sold.

In order for the drug to be recognized, it must be authorized and sold in at least one of the countries from the Pan-American Health Organization (PAHO) or the World Health Organization (WHO), since they are the Regional Authorities; or, they must have a health notification issued by the Authorities in: the United States, Canada, Australia, Japan, by the European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of South Korea. However, the recognition from one of these foreign authorizations is only one of the requirements to obtain the authorization to import the goods.

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

There are not procedures regarding reimbursement of orphan drugs.

8. How are the prices of Orphan Drugs regulated?

The price regulation is the same as that of a general medicine, once the health registration of the medicine has been obtained, the “regime confirmation” must proceed, which will be carried out in the Technical Secretariat for the Approval of Prices for Drugs, who will determine whether the price is regulated (established by the authority) or free (determined by the owner of the goods).

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

There is no reference based on other countries. The price parameter is fixed based on the analysis of the competent Authority.

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

No developments exist regarding these types of orphan drugs.

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?

There are many proposals regarding regulations of these types of drugs, especially for establishing timeframes to import them. However, there is no priority interest with respect to the authorities.

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6. Regulatory Reforms: Ecuador

The key facts about regulatory reforms in Ecuadorian Pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

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

Currently there are no proposals to change the Law.

2. When are they likely to come into force?

It is unlikely that the new law will be approved this year due to the political changes in the country, where the political party encouraging the adoption of the new law has lost its majority in Congress.

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7. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Ecuador

An intro to the legal situation for medical cannabis, cannabinoid drugs and opioids in Ecuador. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

On September 17, 2019, the Congress approved the production, commercialization, distribution, use and consumption of cannabis for medicinal or therapeutic uses in the country.

lArt. 220 of the Criminal Code, provides: “(…) The possession or possession of drugs that contain the active principle of cannabis or derivatives for therapeutic, palliative, medicinal purposes or for the exercise of alternative medicine in order to guaranteeing health will not be punishable, provided that the suffering of a disease is proven through a professional diagnosis. (…) ”;

On February 10, 2021, the Sanitary Technical Regulations for the Regulation and Control of Finished Products for Human Use and Consumption Containing Non-Psychoactive Cannabis or Hemp, or Non-Psychoactive Cannabis Derivatives or Hemp, were approved, thus allowing registration of drugs that contain cannabis or hemp in their composition.

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

The Internal affairs Ministry.

The Health Ministry.

National Agency for Regulation, Control and Sanitary Surveillance (ARCSA).

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

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

None.

The Regulations for Cannabinoid Drugs is still under study.

Pharmaceutical products not subject to control are considered to be drugs in general, processed natural products for medicinal use and homeopathic products that have predominantly cannabidiol (CBD) and cannabis or cannabis derivatives in their formulation, as appropriate, with a percentage lower than 1% of delta-9-tetrahydrocannabinol (THC).

All products for human use and consumption that contain in their formulation cannabis or cannabis derivatives with a percentage equal to or greater than 1% of THC will be regulated as drugs that contain listed substances subject to control.

5. Who can prescribe Cannabinoid Drugs?

The draft Regulations for the Prescription, Commercialization and Transport of Drugs containing substances subject to control (Narcotic Psychotropic Drugs) and the Supply and Control of Special Prescriptions, establishes:

“Health professionals authorized to prescribe drugs containing narcotic or psychotropic substances are:

Physicians (general and specialist); and
Dentists.

The prescription of drugs containing narcotic and psychotropic substances, by dental professionals authorized to prescribe, must be tied to user / patient treatment protocols approved by the National Health Authority.

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

Not yet.

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

The draft Regulation for the Therapeutic Use, Prescription and Commercialization of Medicinal Cannabis and Pharmaceutical Products containing Cannabinoids, proposes: Health professionals approved to prescribe controlled drugs that contain cannabinoids with a THC concentration equal to or greater than 1% are those authorized to issue special prescriptions. Said prescription will be issued in accordance with the medical conditions detailed in article 4 of these Regulations and in accordance with the provisions of the treatment protocols for national or international use.

Health professionals authorized to prescribe pharmaceutical products containing cannabinoids in a THC concentration of less than 1% are health professionals authorized to prescribe, with a professional license issued by a Higher Education Institution recognized by SENESCYT or whoever has these duties and registered with the National Health Authority. Said prescription shall contemplate what is listed in these regulations, and in accordance with the provisions of the recognized treatment protocols for national or international use.

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

The Draft Regulation for the Therapeutic Use, Prescription and Commercialization of Medicinal Cannabis and Pharmaceutical Products containing Cannabinoids, states:

The commercialization and sale of drugs containing cannabinoids and a THC concentration equal to or greater than 1% may only be carried out by private pharmacies and pharmacies of public and private health facilities, which have the corresponding operating permit granted by the ARCSA or ACESS, respectively, upon evidencing a Special Prescription for drugs containing listed substances subject to control, duly signed by the health professional authorized to issue special prescriptions, as established in this Regulations.

The commercialization and sale of pharmaceutical products containing cannabinoids in a THC concentration of less than 1% may only be carried out by private pharmacies and medicine cabinets and pharmacies of public and private health facilities that have the corresponding operating permit granted by the ARCSA or ACESS, respectively, upon evidencing a Special Prescription for drugs containing listed substances subject to control, duly signed by the health professional authorized to issue special prescriptions, as established in this Regulations.

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?

Currently there is no reform under discussion to the Criminal Code (COIP). The Sanitary Technical Regulations for the Regulation and Control of Products for Human Use and Consumption that contain non-psychoactive Cannabis or hemp, or its derivatives, are in a draft stage.

11. When are they likely to come into force?

N/A.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

On September 17, 2019, the Congress approved the production, commercialization, distribution, use and consumption of cannabis for medicinal or therapeutic uses in the country.

Art. 220 of the Criminal Code, provides: “(…) The possession or possession of drugs that contain the active principle of cannabis or derivatives for therapeutic, palliative, medicinal purposes or for the exercise of alternative medicine to guaranteeing health will not be punishable, provided that the suffering of a disease is proven through a professional diagnosis. (…)”

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

The Internal affairs Ministry

The Health Ministry

National Agency for Regulation, Control and Sanitary Surveillance (ARCSA).

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

The authorization of sale, pricing and reimbursement of medicinal cannabis are not regulated yet.

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

The production and importation of non-psychoactive hemp seeds is regulated by the Ministry of Agriculture.

The National Agency for Regulation, Control and Health Surveillance ARCSA will oversee medicinal cannabis.

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

The import, planting, cultivation, harvest, post-harvest, storage, transportation, processing, commercialization and export of non-psychoactive Cannabis or hemp and hemp for industrial use is regulated by the Ministry of Agriculture under Ministerial Agreement No. 109. In The Sanitary Technical Regulations for the Regulation and Control of Products for Human Use and Consumption that contain non-psychoactive Cannabis or hemp, or its derivatives, which is in a draft stage, sated: The manufacture of drugs in general, processed natural products for medicinal use and homeopathic products that contain in their formulation cannabis or cannabis derivatives, as appropriate, in a percentage lower than 1% of THC should only be carried out in pharmaceutical laboratories that have the permission. of current operation granted by the ARCSA and must have a current certification of Good Manufacturing Practices, according to the regulations issued for that purpose.

Drugs in general, processed natural products for medicinal use and homeopathic products that contain in their formulation cannabis or cannabis derivatives, as appropriate, in a percentage lower than 1% of THC must be marketed in pharmaceutical establishments authorized for this purpose by the ARCSA, in accordance with the activity described in its operating permit, with the sale method determined during the process of granting the corresponding marketing authorization, in accordance with current regulations.

For the importation of cannabis derivatives that will be used in the manufacture of pilot batches of drugs in general and that have not yet obtained the corresponding marketing authorization, the legal representative of the interested party must upload through ARCSA’s management system -Quipux-, a request for each import of the raw material to produce the pilot batch or batches. The following requirements apply:

Composition formula of the product to be produced as pilot batches which describes and justifies the use and quantity of the cannabis derivative per pilot batch;
Establishment where the pilot lots will take place;
Execution schedule of the pilot batch;
Invoice or proforma of the raw material addressed to the manufacturing establishment of the pilot batch;
Official fee;
Product elaboration process to be carried out in the pilot batch; and
Technical data sheet and certificate of analysis of the raw material to be used, from the country of origin.

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

There are currently no regulatory frameworks for the marketing and distribution of medicinal cannabis.

However, in the draft Regulations for the Regulation and Control of Products for Human Use and Consumption that contain non-psychoactive Cannabis or hemp, or its derivatives, it is proposed:

Drugs in general, processed natural products for medicinal use and homeopathic products that contain in their formulation cannabis or cannabis derivatives, as appropriate, in a percentage lower than 1% of THC must be marketed in pharmaceutical establishments authorized for this purpose by ARCSA, in accordance with the activity described in its operating permit, with the sale method determined during the marketing authorization process, in accordance with current regulations.

18. How can patients obtain Medicinal Cannabis?

Currently not possible.

19. Who can prescribe Medicinal Cannabis?

Currently, nobody.

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

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

It is currently not possible to prescribe medicinal cannabis.

22. Where is Medicinal Cannabis available?

Currently not available.

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

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

Currently there is no reform under discussion to the Criminal Code (COIP). The Regulations for the Regulation and Control of Products for Human Use and Consumption that contain non-psychoactive Cannabis or hemp, or its derivatives, are in a draft stage.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Yes

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

Ministry of Health

National Regulatory Agency (ARCSA)

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

Yes, for the registration of an opioid medication there are certain requirements, as follows:

Register with ARCSA as an importer / vendor / distributor of medications that contain substances categorized as subject to control.
Certificate of administration of substances categorized as subject to control, issued by the Technical Secretary of Drugs (SETED) – if registering with ARCSA as producer.
Annual projections of consumption of imported medications that contain substances categorized as subject to control.
List of possible clients (if registering as vendor).

The Ministry of Health will set the maximum price for the sale of these medications, through the Technical Secretary for Medication Price Control.

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

There are various opioids registered in Ecuador, either as combination drugs or mono drugs. The main ones are as follows:

Hydrocodone
Oxycodone
Morphine
Codeine
Methadone
Fentanyl

29. Who can prescribe Opioid Drugs?

Health professionals authorized for the prescription of medications that contain substances categorized as subject to control (opioids).

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

Yes, the Minister of Health maintains an up-to-date register of authorized professionals.

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

Be a health professional that treats illnesses which have shown effective therapeutic responses to the use of opioids. Such professional must be authorized by the Minister of Health.

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

Authorities that are registered with ARCSA for the purpose of the administration of medications that contain substances categorized as subject to control (opioids).

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

The Minister of Health holds an up-to-date list of which distributors may sell these medications.

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

No.

35. When are they likely to come into force?

N/A

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8. Patents & Trademarks: Ecuador

A structured legal guide about patents & trademarks in Ecuadorian Pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

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

Any sign that is capable of distinguishing goods and services on the market shall constitute a mark. Signs that are capable of graphic representation shall be eligible for registration as a mark; in particular, the shape of a product, its packaging or wrapping may constitute a trademark.

Patents will be granted for inventions, whether for goods or processes, in all areas of technology, provided that they are new, involve an inventiveness, and are industrially applicable.

2. What agencies or bodies regulate patents and trademarks?

The local IP Office SENADI is the entity in charge of regulating patents and trademarks.

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

For trademarks there are basically no restrictions; protection will be granted to all non-traditional marks including 3D marks.

The patentability exceptions are: a) discoveries, scientific theories, and mathematical methods; b) Any living thing, either complete or partial, as found in nature, natural biological processes, and biological material, as existing in nature, or able to be separated, including the genome or germ plasma of any living thing; c) literary and artistic works or any other aesthetic creation protected by copyright; d) plans, rules, and methods for the pursuit of intellectual activities, playing of games, or economic and business activities; e) computer programs and software, as such; f) methods for presenting information; g) therapeutic or surgical methods; and, h) second and novel uses.

4. How can patents and trademarks be revoked?

TRADEMARKS

Cancellation: A mark becomes vulnerable to a cancellation action for lack of use (total or partial) if it has not been used by its registered owner (for all the protected goods/services in the case of a partial cancellation) within the past three years in at least one of the Andean Countries (Colombia, Ecuador, Peru and Bolivia). The burden of proof of use of the mark falls on the owner of the registration. A positive resolution in a cancellation action grants the plaintiff preferential rights to register the cancelled mark and this action may be also brought as a defense in an opposition proceeding.

A cancellation action for notoriety may be brought when notoriety existed in any country party to the Paris Convention and/or member of the Andean Community, at the time the challenged Ecuadorian mark was filed and continues at the time the action is brought.

Where the owner of the mark has caused or allowed that mark to become a common or generic sign to identify or denote one or several of the goods or services for which it was registered, the competent national office shall order, ex-officio or at the request of a party, the cancellation of the mark or the limitation of its scope.

Nullity: The authority shall either ex-officio or at the request of an interested party and at any time, declare the registration of a mark absolutely null and void when registration of such mark was granted against absolute grounds for refusal. The authority, shall either ex-officio or at the request of a third party with legitimate interest, declare the invalidation of a registration where granted in contravention of relative or absolute grounds for refusal or obtained in bad faith.

PATENTS

Andean Decision 486, which is the IP supra-national law applicable in Ecuador, determines that the competent national authority may, either ex-officio or at a request of a party, and at any time, declare a patent null and void, when the subject matter of the patent is not an invention (i.e., discoveries, scientific theories, mathematical methods, living things as found in nature, literary and artistic works, plans, rules, and methods for pursuing intellectual activities, playing of games, or economic and business activities, computer programs and software, as such, and methods for presenting information).

Other causes of nullity are the lack of fulfillment of the patentability requirements (novelty, inventiveness, industrial applicability), matter excluded from patentability (inventions whose commercial exploitation is necessary to protect public order, human or animal health and the environment, plants or animals and essential biological process for their production other than non-biological or microbiological processes, diagnostic, therapeutic, and surgical methods for the treatment of humans or animals), lack of proper disclosure of the invention or lack of deposit of biological material; claims not duly supported by the specification; a granted patent that is of broader scope than the original application; lack of the access contract of genetic resources in such inventions, or lack of a document certifying the existence of a license or authorization for use of traditional knowledge belonging to local communities.

The nullity of a patent can also be declared when there are grounds for absolute invalidation according to domestic law covering administrative acts and is applicable to the claims or parts thereof that are affected. The defects in administrative acts that have not brought about absolute invalidity shall result in relative invalidity. In such cases the competent national authority shall declare such invalidity within the following five years counted from the date of the grant of the patent, as provided for by the national law.

The patent, claim, or part of a claim that has been invalidated shall be deemed null and void as from the filing date of the patent application.

The competent national authority may cancel a patent where it has been granted to a person not entitled to such grant. The action for cancellation may only be brought by the person to whom the right to the patent belongs. Such an action shall not be possible after five years following the date of grant of the patent, or after two years following the date on which the person to whom that right belongs became aware of the exploitation of the invention in the country, whichever period expires first.

The competent national authority ruling on a case of invalidity shall inform the owner of the patent so that he may present such arguments and submit such evidence as he may consider fit. Where this is necessary for a ruling on the invalidity of a patent, the national authority may request the owner of the patent to submit documents referring to expert opinions or related patentability examinations performed by other patent authorities.

In addition, the local IP Law in force since December 2016 introduces sanctions for the falsehood, deliberate omission, deliberate obscurity or deliberate complication of the information in the application or in the description of the invention, hindering the national competent IP authority from examining the patent application, misleading it in the examination or not allowing it to be put into practice, which will be grounds for rejection of the application or absolute nullity of the granted patent, without prejudice to the claim for damages of any third party affected.

On the other hand, the local IP Law introduced limitations as to the patentability of several products, defining as non-inventions the new forms of a substance, including salts, esters, ethers, complexes, combinations and other derivatives; polymorphs, metabolites, pure forms, particle sizes and isomers. These restrictions would be against the Supranational Law, and therefore not applicable.

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

In general terms foreign trademarks and patents are not recognized. Ecuador is a first to file country for trademarks. The sole exception is for well-known trademarks.

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

There are no non-patent/trademark barriers to competition to protect medicines or devices.

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

There are no restrictions.

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

License agreements do not require approval; however, registration with the IP Office is advisable in order to be enforceable against third parties.

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9. Product Liability: Ecuador

The inside track on product liability in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

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

In general terms, liability arises from the Civil and Criminal Codes, and it is a personal responsibility for actions or omissions. However, the Consumer Protection Law establishes that civil damages may be claimed in case of damages caused by a defective or damaged product where the manufacturers, importers, distributors, sellers, or whoever may have put their trademark on the goods, are responsible.

Those jointly liable may repeat the action against the main responsible party.

The proceedings for damages in Ecuador are not common, since it is necessary to quantify and demonstrate the damage and also show the relationship of cause / effect between the actions/omissions and the damages caused using substantial evidence.

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

The law establishes that the holder of the marketing authorization for the medicine or medical device is legally and technically responsible for the quality of the product within the country. It is common that if the owner of the registration and the manufacturer of the product are different companies, agreements are entered into setting out the obligations of each party involved in the event that litigation arises involving the products.

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

Civil liability only extends to the holder of the marketing authorization and jointly to those who take part in the production, manufacturing, and sale of the product, provided they participate directly as individuals. Joint liability does not extend to those individuals who work or represent a legal entity.

4. How can a liability claim be brought?

The affected party can appear before a contraventions court, who will determine the existence of an infringement and order, if applicable, the payment of compensation in favor of the claimant, which must be paid in a new civil proceeding.

The affected party may also go directly before a civil judge. However, they must provide all evidence demonstrating the existence of the infringement, the relationship between the action / omission and the effect, and the responsibility of the defendant.

If there is a group of people who claim to be affected, it will be necessary for each of them to ratify the claim and appear in the proceeding. They could all name the same attorney in fact, thereby creating similar conditions to that of a class action.

Consumer associations duly established in accordance with the Law could also bring this type of action.

5. What defenses are available?

The holder of the marketing authorization is the one who must respond in a proceeding.

Through contractual provisions, the other parties involved in the process of manufacturing and sale of the goods may appear in the proceeding or, in turn, assume the costs of the defense. In the event of being ordered to pay damages, the action can always be repeated through a separate action against the party responsible for the infringement or non-compliance (not the legal representative, as it will always be the holder of the marketing authorization).

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10. Traditional Medicines and OTC Products: Ecuador

Need info on traditional medicine and OTC products in Ecuador? Read on! Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

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

Traditional, complementary or alternative medicines are governed by the General Health Law (HL) and its regulations.

These medicines are known as natural, whose active ingredients are formed by any part of natural medicinal resources or combinations thereof, such as a crude drug, extracts or a recognized pharmaceutical form, used for therapeutic purposes.

These will not be considered a processed natural product for medicinal use if the natural resource for medicinal use is combined with chemical active substances, including constituents of natural resources, isolated and chemically defined.

These medications will not be injectable; their use will only be oral or topical.

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

Advertising is possible with prior authorization from the General Health Directorate. Advertising can be through any means.

It is not possible to advertise medicines that require a prescription.

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

The advertising of traditional, herbal, complementary, or alternative products directed at the general public should include the therapeutic indications or uses of the medicine and must be in accordance with the marketing authorization certificate. The information contained in the advertising material cannot induce a false, erroneous and/or confusing interpretation of the product. It must be clear and in an understandable language.

The product should include the following phrases: “medicinal product, keep out of the reach of children” and “in case of adverse effects, immediately contact ARCSA and the Holder of the Marketing Authorization”.

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

OTC medications must demonstrate efficacy and safety in relation to the prevention and relief of symptoms or signs of mild diseases of easy identification; that they have a wide range of safety, in such a way that the voluntary or involuntary administration of doses higher than those recommended does not represent a serious danger to the patient’s health; that they have a wide range of dosage, which can be adapted to the age and weight of the patient; that their use does not generate tolerance or dependence and that they are not susceptible to abuse; that when used according to the instructions, they do not mask serious diseases or delay the diagnosis and treatment of a condition that requires medical attention; that their use is safe in all groups of the population; that the dosage forms are generally oral or topical and not injectable; that the active ingredient has been marketed under medical prescription for at least ten (10) years, demonstrating a favorable safety and efficacy index documented with drug monitoring data; that reports of adverse reactions have not increased during the period in which the medication has been in use.

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

OTC is defined as an oral or topical medication that, due to its composition and the pharmacological action of its active ingredients is authorized to be sold or dispensed without prescription.

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

The HL states that all medicines including OTC products must be commercialized in legally authorized establishments, which hold the mandatory permits.

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

The advertising of OTC products directed at the general public should include the therapeutic indications or uses of the medicine and must be in accordance with the marketing authorization certificate. The information contained in the advertising must be in a clear and understandable language.

The phrase “If the symptoms persist, consult your doctor” should be included on the product.

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

There is no process expressly established to convert a product sold only by prescription into an OTC product. However, the holder of the marketing authorization may submit a written request to ARCSA to request the reclassification. ARCSA will determine the reclassification process, in accordance with the criteria mentioned in this chapter.

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

The HL establishes that marketing authorizations for medicines in general must be obtained from ARCSA prior to importation including traditional medicines.

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11. Marketing, Manufacturing, Packaging & Labelling: Ecuador

Legal info on marketing, manufacturing, packaging & labelling in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

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

The authorization process for the marketing of new drugs, biologics, medical devices, OTC and other medicinal products is through a marketing authorization as detailed in question 3 of Regulatory, Pricing and Reimbursement.

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

The authorization process and requirements for the marketing of generic versions is the same, the only difference is in the labeling requirements

3. What are the typical fees for marketing approval?

Official fees foreign manufactured pharmaceuticals US$2,258.41
Official fees local manufactured pharmaceuticals US$904.34
Official fees foreign manufactured generics US$565.21
Official fees local manufactured generics US$510.51
Official fees generic drugs included in the basic pharmaceuticals chart US$452.17

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

The validity of a marketing authorization for a pharmaceutical or medical device is 5 years. The automatic renewal proceeding applies in the case of products that during their period of validity have not had changes or modifications in their intended use, as well as in their quality, safety and efficacy; and that they have not been subject to suspension by the Health Authority.

The holder of the marketing authorization must file an automatic renewal request at least ninety (90) days before the expiration date of the health registration.

The marketing authorization is renewed within 15 working days for a 5-year period.

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

The holders of a marketing authorization for medicines that are marketed in Ecuador have the obligation to:

Notify the National Pharmacovigilance Council of all suspected adverse events, which occur in the country, or in another country where clinical trials are conducted and/or the product is marketed.
Keep a detailed record of all suspected adverse events, which occur in the country, or in another country where clinical studies are conducted and/or the product is marketed;
Submit safety reports every six months for new medicines (new API in Ecuador), which will allow the rectification or ratification of indications, contraindications, adverse effects, and to obtain relevant information on the safety and therapeutic efficacy of the product. When a negative response is detected that exceeds the established safety limits, it must be reported immediately to the National Pharmacovigilance Council;
Implement modifications in the technical sheet, the labeling and the prospectus or insert as required by ARCSA.

The establishments of medical devices and in vitro diagnostic biochemical reagents for human use that produce, import, export, distribute, market, store, dispense and sell such goods have the following obligations:

Collaborate with the National System of Technological Surveillance as to the identification, prevention and notification before ARCSA, about the   risks associated with medical devices;
Notification of any suspected adverse events and adverse incidents to the   National Pharmacovigilance Council;
Keep a detailed record and a physical or digital file system of all the suspected  adverse events and adverse incidents for at least 5 years.
Continuous staff training in technological surveillance.

6. Are foreign marketing authorizations recognized?

Homologations are allowed for medicines, which means official recognition of the marketing authorization granted by health authorities of the countries whose regulatory agencies for medicines have been certified by the Pan American Health Organization (PAHO) / World Health Organization (WHO) as Regional Reference Authorities, as well as those marketing authorizations granted by the health authorities of the United States of America, Canada, Australia, Japan, the European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of South Korea.

For a homologation to be approved in medicines, it must originate in the aforementioned countries, be part of the basic medicines required by the country (National Table of Basic Medicines) and the medicine has not been registered in the country or there are less than 5 records of the active principle, concentration and pharmaceutical form in the country.

LIST OF APPROVED COUNTRIES FOR THE HOMOLOGATION PROCESS

REGULATION	AGENCY	COUNTRY	OBSERVATIONS
Regulatory agencies qualified by the PAHO/ WHO	INVIMA, ANVISA, ANMAT, COFEPRIS, COCMED	Colombia, Brazil, Argentina, Mexico, Cuba	Marketing authorization or its equivalent
United States of America	FDA	United States of America	Marketing authorization or its equivalent
Canada	Health Canada	Canada	Marketing authorization or its equivalent
Australia	Therapeutic Goods Administration	Australia	Marketing authorization or its equivalent
Japan	Pharmaceuticals and Medical Devices Agency	Japan	Marketing authorization or its equivalent
Ministry of Food and Drug Safety	Ministry of Food and Drug Safety	Republic of South Korea	Marketing authorization or its equivalent
European Medicines Agency (EMA)	European Medicines Agency (EMA)	All member countries of the European Community through the EMA*	Only Certifications of Medicines issued by the European Medicines Agency (EMA) are accepted. Certifications of regular authorities of the member countries of the European Community are not accepted.

*Member Countries of the European Medicines Agency (EMA): Belgium, Bulgaria, Czech Republic, Denmark, Germany, Austria, Croatia, Slovakia, Slovenia, Estonia, Greece, Spain, France, Finland, Ireland, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, Netherlands, Poland, Portugal, Romania, United Kingdom, Sweden.

7. Are parallel imports of medicines or devices allowed?

Parallel imports are prohibited in Ecuador since a marketing authorization is required for the import, sale, manufacturing, import and export of pharmaceuticals and medical devices.

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 promotion of medicines and medical devices must be made to the health professionals authorized to prescribe, through a pharmaceutical sales representative. In these visits it is forbidden to grant or offer gifts, prizes, economic incentives, trips and similar, by pharmaceutical establishments dedicated to the manufacture, storage, distribution, commercialization and dispensing of medicines in general, processed natural products of medicinal use and homeopathic medicines.

It is forbidden that scientific, sporting, cultural and other similar events are sponsored with the name of medicines in general, natural medicinal products, homeopathic medicines and medical devices. Pharmaceutical sales representatives are prohibited from all public health services.

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

The authority responsible for enforcing the regulatory framework in relation to medicines and medical devices is the National Agency for Regulation, Control and Sanitary Surveillance (ARCSA).

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

In Ecuador, the certificate of GMP is granted by ARCSA, after complying with the requirements established in the local GMP Regulations for Pharmaceutical Laboratories, which is based on Annex 1 of Report 32 of the World Health Organization.

In the case of medical devices, the regulation that will regulate GMP is in the process of being approved and the certification will be granted by external organizations that will work in conjunction with ARCSA.

11. What is the inspection regime for manufacturing facilities?

ARCSA is empowered to make on-site visits at any time to inspect premises and verify compliance and can initiate ex-officio legal proceedings to sanction non-compliance. Ultimately, these legal proceedings can result in fines, seizures, the revocation of the marketing authorization and closing of facilities. GMP, stability, labelling standards and all other applicable provisions must be complied with. The marketing authorization holder must have a programme to recall and destroy products that do not meet quality standards.

GMP inspections will be carried out by qualified technical personnel from ARCSA, and eventually, depending on the case, advisors with a specialized technical background but without voting rights can participate.

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

Inspections are performed solely by ARCSA.

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

The main requirement is the Good Storage, Distribution and Transportation Practices (GSP/GDP/GTP) Certificate issued by ARCSA.

To obtain it, the company must comply with the following:

Legal personality;
Legal representative;
Equipment and facilities that correspond to the activities developed.
Operation permit issued by ARCSA.
Technical advice from a Biochemical Pharmacist employed by the establishment.
Documentation describing the functions and responsibilities of the staff in the pharmaceutical establishment.
Standard Operating Procedures (SOPs) according to the activities developed.
Technical documentation of all activities.

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

MEDICINES IN GENERAL:

Name of the product.
Generic name (DCI)
Pharmaceutical form.
Container net content expressed in the International System of Units (SI, from the French Le Système International d’Unités)
Qualitative-quantitative formula.
Administration routes.
Batch number or code.
Pediatric use if the product requires it.
Conservation temperature.
Manufacturer’s name, city and country.
Date of manufacture and expiration.
Marketing authorization number.
Sales specification:
1. OTC.
2. Under medical prescription.
3. Under controlled prescription.
4. Restricted circulation.
Sales price (PVP)

GENERICS

In case of generics it is also mandatory to include the generic name in capital letters, red color, Pantone Red 032 and of a size 20% larger than the brand name of the product.

MEDICAL DEVICES

Commercial name of the product;
Container or packaging contents;
Use indications, where appropriate;
Warning and precautions of use; the use of symbols is permitted;
Storage conditions, the use of symbols is permitted;
Manufacturer’s name, city and country;
Manufacturing locations, where appropriate,
Expiration date, where appropriate;
Shelf life, where appropriate;
Storage temperature, where appropriate;
Batch number / series;
Marketing authorization number;
Sales price (PVP);

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

a. For OTC, the label shall include:

Warning: “If symptoms persist, consult your doctor.”

b. In medical samples, labels must declare:

“Medical Sample, sales prohibited”.

c. Other information; using images or symbols description, where appropriate.
Eg.
1. “Protect from light”.
2. “This product should not be administered during pregnancy or when its existence is suspected”

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

Slogans such as: “the greatest choice”, “the most frequently recommended”, “the best”, “totally reliable”; “the most effective”, among others not scientifically demonstrable.

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

Goods that require prescription cannot be advertised.

General publicity for OTC medicines and devices is possible with prior authorization from the Health Ministry (HM).

The advertisement must indicate the therapeutic indications or uses of the product. In case of advertising in audiovisual and printed media (such as brochures, flyers, leaflets), the advertising content should contrast its color with the background of the advertisement.

The advertising permit will be valid for 6 months under the conditions on which it was approved.

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

The HL establishes that all medicines including OTC goods must be sold in authorized establishments, holding the corresponding permits.

Medicines and devices can be delivered by entities holding the necessary permits (GSP/GDP/GTP).

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

The HM is in charge of monitoring this type of publicity and checking that they have all the corresponding permits. The HM also monitors that the advertising is within the authorization parameters. If there is a breach, the advertising authorization can be suspended and fines imposed.

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

Only OTC can be advertised to the general public, with prior approval. All medicinal goods need to be sold in facilities holding the necessary permits

ARCSA permanently controls all aspects of medicines and medical devices.

21. How is compliance monitored?

It is also common that competitors raise claims for non-compliance with ARCSA.

22. What are the potential penalties for noncompliance?

The sanctions for not complying with the advertising rules are the suspension of advertising activities and fines and in certain cases the temporary or definitive closure of the establishment.

In addition, if the breach of the advertising rules deceives consumers and generates a competitive advantage, a fine of up to 10 % of the infringing party’s total turnover in the fiscal year preceding that of the fine, may be imposed by the Superintendence for Market Power Control (SCPM).

Goods that require prescription cannot be advertised.

General publicity for OTC medicines and devices is possible.

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12. Preclinical and Clinical Trial Requirements: Ecuador

Key info on preclinical and clinical trial requirements in Ecuador. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

As a general introduction, Clinical Trials are regulated in Ecuador via Ministerial Agreement (MA) 0075-2017 related to regulations for the approval, development, monitoring and control of clinical trials. This regulation was enacted on June 30th, 2017. There are other rules and regulations which make MA 0075-2017 enforceable.

The Constitution of the Republic of Ecuador in subparagraph d), 3, of Section 66, prohibits the use of genetic material and scientific experimentation that violate human rights.

Every person without discrimination has in relation to health the right not to be the subject of tests, clinical trials, laboratory or research, without their knowledge and prior written consent, nor be subjected to tests or examinations diagnoses, except when the law expressly determines it or in case of emergency or urgency in which his/her life is in danger, as determined in article 7, literal l) of the Health Law.

The Code of Childhood and Adolescence, in Section 20 expresses: “Right to life. Children and adolescents have the right to life from the moment of conception. It is the obligation of the State, society and family to ensure by all means, their survival and development. Medical and genetic experiments and manipulations may not be conducted on pregnant women, children or adolescents, nor the use of any technique or practice that endangers the lives or affects the integrity or integral development of any of the aforementioned.”

It is ARCSA’s responsibility “to approve clinical trials of medicines, medical devices, natural products for medicinal use and other products subject to registration and sanitary control based on regulations issued by the HM.”

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

Clinical trials must be conducted under conditions that ensure respect for human dignity, human rights, autonomy, informed consent, precautionary principle, personal integrity, privacy, confidentiality, equality, justice, equity, discrimination, cultural diversity and well-being of people. According to our law, rights, safety and well-being of individuals and society will prevail over scientific and economic interests. Therapeutic benefits and the risks and disadvantages for the subject of the trial and for public health will be evaluated.

2. How are clinical trials funded?

Clinical trials are generally funded privately. In order to carry out a clinical trial in our country, all persons, whether public, private, national or foreign who are sponsoring the trial, must request prior approval from ARCSA, who will also verify and inspect compliance with legal, ethical and methodological aspects for the development of the clinical trial in the country, before, during and after it is carried out, as well as all aspects related to research technology.

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

To authorize a clinical trial, ARCSA will request the sponsor to submit the necessary documents in Spanish or its official translation, duly legalized either by Apostille or Ecuadorian Consulate. Requirements for preclinical and clinical trial protocols are those defined in Section 8 of MA 0075-2017. Approval for conducting clinical trials are made by ARCSA, who must abide by the Constitution of the Republic of Ecuador; the directives contained in the Declaration of Helsinki (PARF network); CIOMS guidelines; and Good Clinical Practices established by agreements to which Ecuador is part of.

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

Participants must voluntarily submit to clinical trials. Participants must be previously informed about the trial, which must be accepted through an informed consent document. These people may or may not suffer from diseases. The research subjects will be supplied with the investigational product or the product that is used as a control, once their informed consent or that of their legal representative has been obtained, in the corresponding cases.

Clinical trials conducted with senior people, people with disabilities, people deprived of their freedom and those suffering from catastrophic and highly complex diseases, because they are considered priority or vulnerable care groups, should be of specific interest and limited to those that by their nature can only be carried out with these population groups.

In women of a reproductive age and who have consented to participate in a clinical trial, prior to starting the same, the need to confirm the participant is not pregnant is indispensable. Access to and use of an effective contraceptive method must be ensured during the development of the clinical trial, which will be provided at no cost by the sponsor, during the entire time of their participation in the study, including male subjects.

For clinical studies conducted in indigenous towns and on indigenous peoples, in addition to an individual informed consent, a prior community consultation should be conducted, which should be favorable to the completion of the study. Additionally, approval from the authorities of the community involved in the case must be obtained. Said approval must be included in a document duly signed by these authorities, copy of which will be attached to the procedures for requesting approval to conduct the clinical trial. It will not be possible to carry out clinical trials in villages in voluntary isolation.

In these clinical studies, sponsors and researchers should develop culturally appropriate ways and means with anthropologists, sociologists and translators, to communicate to the participants in the research, all the necessary information regarding the trial and meet the standard required in the informed consent process. In addition, the research protocol should describe and justify the procedure they plan to use to communicate the information to the subjects under investigation.

5. May participants in clinical trials be compensated?

In exceptional cases, clinical trials participants may be compensated economically, keeping in mind they must be healthy adults.

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

Good Clinical Practices (BPC) are regulated by ARCSA and must be observed during trials. ARCSA will periodically inspect and control BPC’s are complied with under penalty of declaring the continuity of the trial. Sponsors must establish a plan to remediate any inconformity or safety of the participant.

A liability insurance policy must be provided by sponsor to participants and in those cases where such policy does not cover/apply, sponsor will be responsible for relief of any harm or damages suffered by participant. Sponsor will guarantee and provide free medical assistance until all health problems are solved, derived from their participation in a clinical trial.

Economic compensation must be provided by sponsor to participant in case of evidence of harm or damage and its causal relationship with the product under investigation.

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Also from this Legal Handbook

13. Regulatory, Pricing and Reimbursement: Ecuador

All you need to know about regulation, pricing and reimbursement in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

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

The authority responsible for applying and enforcing the regulatory framework in relation to human medicines, biologicals, and medical devices is the National Agency for Regulation, Control and Sanitary Surveillance (ARCSA), which is a decentralized agency of the Health Ministry (HM).

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

The primary legislation for the authorization, pricing and reimbursement of medicines biologicals, and medical devices is the Health Law (HL) and its regulations, based on the World Health Organization (WHO) guidelines.

ARCSA is the regulating Agency for sanitary control, marketing authorizations are required for imported and domestic products such as medicines, biologicals, and medical devices. As for the approval and revision of pricing, the entity responsible is the National Council for Fixing and Reviewing Drug Prices (CNDP) which is part of the HM.

In Ecuador, the commercialization of medicines and biologicals without a marketing authorization and price determination is prohibited.

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

Essentially, applicants applying for marketing authorizations must prove the safety and efficacy of their products through clinical trials, according to the rules set out by the HL and its regulations, not only covering the products but also the active ingredients.

Manufacturers must provide all information about the developing, testing, and marketing of their products in the Ecuadorian territory and when applicable, from abroad. The information must include the following:

Analytical methodology of the active ingredient and the final product.
Certificate of analysis in drug control tests standards.
Stability studies to be carried out in Climate Zone IV subtropical with   possible high humidity, according to the OMS classification.
Analysis procedure for identification, quantification, evaluation of the   physical, physical-chemical, biological, chemical, microbiological, pharma-  cological characteristics of the finished product.
Preclinical studies (where appropriate)
Toxicity report.
Pharmacological report.
Immunogenicity report.
Pharmacokinetics Studies.
Pharmacodynamics Studies.
Clinical Trials.
Certificate of Pharmaceutical Product (CPP)
Certificate of Analysis (CoA)
Coloindex by FDA (where appropriate)
Product specifications.
Manufacturing process description.

Research and Development companies can benefit from an approval procedure for medicines, when they have been previously approved by:

The European Medicines Agency (EMA)
The US Drug and Food Administration (FDA)
Health Canada

It is the responsibility of the investigating laboratory to issue a responsibility letter, stating:

Certification of the research plan (according to international references)
Certificate of experimental phase conclusion of the medicine
Pharmacovigilance programs (3 years after the marketing authorization  granting date)

4. What are the approximate fees for each authorization?

Since there is no research and development of new molecules (medicines) in Ecuador, the Government has not established official fees for this purpose. However, there is a homologation process to obtain marketing authorizations applicable to foreign countries amounting to US$ 2258.41.

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

Marketing authorizations must be renewed every five years for medicines, biologicals and medical devices. The renewal process does not involve official fees and is the procedure through which the marketing authorization is updated once its validity period has ended. The renewal process is carried out in ARCSA’s electronic system; however, it only applies to products that have not changed their characteristics since approval. If the product or any of the legal information changes, the process to follow is the same as for a new marketing authorization, if these changes were not notified prior to the renewal date.

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

There is no differing process between brand name products and generic products, however for brand name products it is necessary to prove safety and provide efficacy parameters. For generic products, it is necessary to prove interchangeability and bio-comparability of the medicine. Labeling requirements also differ, since generics have to declare the International Common Denomination (ICD) and include “Generic Medicine”.

The only difference between local and foreign manufacturers is the applicable government fees, which are less for local manufacturers.

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

Combination products will be registered under the same marketing authorization when in their commercial presentation, another medication or medical device whose purpose is to supply medication is included.

These combination products are regulated by ARCSA which will require a classification process prior to applying for the marketing authorization. Given their particular features, these products can be classified as: medicines (medicines/ biologicals) and/or medical devices (drug/device). Requirements and application timeframes differ in each case, depending on the nature of the combination product.

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?

Compliance is monitored and evaluated by ARCSA. Compliance with GMP, GSP and GTP and standard operating procedures, is comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements.

ARCSA is in process of strengthening the pharmacovigilance program that will ensure all procedures are controlled from manufacturing until post registration control.

9. What is the potential range of penalties for noncompliance?

ARCSA is empowered to make on-site visits at any time to inspect premises and verify compliance and can initiate ex-officio legal proceedings to sanction non-compliance. Penalties include the revocation of the marketing authorization, ordering temporary or definitive closure of facilities and/or fines amounting to approximately US$ 4000.

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

The healthcare system comprises public (social security) and private insurers, out-of-pocket payments and informal arrangements.

The major public segment is The Ecuadorian Institute of Social Security (IESS). This entity provides health services for the self-employed and employees in public and private companies. There are other systems with special structures, for example, for members of the military and police.

The public health sector normally faces financial problems and implements measures to limit costs, for example, by pressing for price reductions in public bids and encouraging competition and the use of generics.

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

Private health insurance generally covers higher economic levels of the private sector. Enrolment in private health insurance has increased considerably over the past few years.

The public and private health sectors function separately. There is no interaction between them.

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

Drugs Prices are fixed by the HM through the CNDP.

There are three applicable regimes for establishing medicine prices:

Regulated: This regime sets the price caps for each market segment of medicines considered essential or new. The price caps for each segment will be calculated with the average of the retail prices in the private market. For new medicines, the level of therapeutic innovation will be used as the basis for establishing the price cap.

Direct: The Government unilaterally sets medicine prices only in specific situations, when essential and new medicines are commercialized without price regulation or companies do not adhere to the price caps.

Open: applies to the products that are not included in the two previous regimes. Manufacturers will be free to set prices but the CNDP must be notified of the price used.

Medical device prices are not regulated.

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

Insurance companies are currently improving the level of coverage by making themselves responsible also for the supply of medicines, since the private market in medicines has grown considerably.

Basically, all payments are made on an out-of-pocket basis. In the public sector, patients should receive the products from the Government; however, in practice patients obtain the products on an out-of-pocket basis.

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

The public health system dispenses the products prescribed by their healthcare professionals. Products are prescribed from a basic medicinal products list, issued by the HM. The Government acquires those listed products mostly by public tender processes, public auctions and medicine acquirement governed by a special regime.

In the private health systems there are options between acquiring the products from private pharmacies and requesting reimbursement or acquiring the products from the insurance provider.

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?

The HM issues prescription regulations that are of mandatory compliance for all members of the National Health System. The medicine dispensers must obtain an operating permit.

The safety and information of the products is the responsibility of the manufacturer and local distributor (if applicable). Safety and information requirements should be complied with when obtaining marketing authorizations for the products.

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