The Pharma Legal Handbook: Bolivia

An insight into regulatory reforms in Bolivian Pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99.

 

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

For several years now they have been talking about a new law that will be issued but we don’t expect it to pass any time soon.

 

2. When are they likely to come into force?

As we stated above, we don’t think that it will be passed any time soon.

 

Also from this Legal Handbook

Want to know more about patents and trademarks in Bolivian pharma? Read on! Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99.

 

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

The formalities to request a trademark registration are:

• Name and design (if applicable) of the brand
• International Classification Nice
• Basic information of the applicant (if the applicant is a company, a Power of Attorney will be required)
• Forms and note of application
• Receipts of Payment of fees

The formalities to request a patent are:

• Three copies of the Application Forms
• Descriptive Memory (Printed)
• Description of the invention: It must disclose the invention in a sufficiently broad and concrete manner.
• Claim: Define the subject that you want to protect through the patent, it must be clear and concise and supported by the description.
• Drawings: If applicable
• Summary: It consists of a synthesis of the technical disclosure contained in the patent application.
• Receipts for payment of the fees established by SENAPI.
• Memorial or application letter.
• Priority if it exists. (Its translation if it is in another language).
• In case of representation, necessary powers in original or legalized copy.
• Assignment of Rights (If applicable).

 

2. What agencies or bodies regulate patents and trademarks?

The “Servicio Nacional de Propiedad Intelectual (SENAPI)” is the public institution that regulates all the patents and trademarks in Bolivia.

 

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

According to the Andean Community Decision No. 486, which establishes the Common Industrial Property Regime, any sign capable of distinguishing goods or services on the market shall constitute a mark. Signs that are susceptible of graphic representation may be registered as marks. The nature of the product or service to which a mark is to be affixed shall in no case be an obstacle to the registration thereof. The following signs, among others, may constitute marks:

1. Words or word combinations;
2. Images, figures, symbols, graphics, logotypes, monograms, portraits, labels, emblems and shields;
3. sounds and aromas;
4. letters and numerals;
5. a color within an outline, or a color combination;
6. the shape of the goods, their containers or their packaging;
7. any combination of the signs or elements specified in the foregoing subparagraphs.

Signs cannot be registered as trademarks if:

1. lack distinctiveness;
2. consist solely of the everyday shape of the goods or their packaging, or of shapes or characteristics dictated by the particular nature or function of the product or service concerned;
3. consist solely of shapes or other elements that afford a functional or technical advantage to the product or service to which they are applied;
4. consist solely of a sign or statement that may serve in business to describe the quality, quantity, purpose, value, place of origin or time of production of, or to impart other data, characteristics or information concerning, the products or services for which the sign or statement is to be used, including expressions extolling the said goods or services;
5. consist solely of a sign or statement which is the generic or technical name of the product or service concerned;
6. consist solely or have become the common or usual designation for the product or service concerned in the everyday language or usage of the country;
7. consist of a color in isolation, without any demarcation to give it a specific shape;
8. are liable to deceive business circles or the public, in particular as to the source, nature, manufacturing methods, characteristics or qualities of the goods or services concerned, or their suitability for their purpose;
9. reproduce, imitate or contain a protected appellation of origin for the same or different goods where use of the sign could create a risk of confusion or association with the said appellation or might constitute misappropriation of its notoriety;
10. contain a protected appellation of origin for wines and spirits;
11. consist of a national or foreign geographical indication liable to cause confusion with regard to the goods or services to which it applies;
12. reproduce or imitate, without the permission of the competent authorities, either as trademarks or as elements of trademarks, coats of arms, flags, emblems or official signs and trademarks denoting control and warranty adopted by States, and any imitation thereof from the heraldic point of view, and also the coats of arms, flags and other emblems, names or abbreviated names of any international organizations;
13. reproduce or imitate signs denoting conformity with technical standards, except where the registration thereof is applied for by the national body responsible for standards and quality requirements in member countries;
14. reproduce, imitate or include the denomination of a plant variety protected in a member country or abroad, if the sign is intended for goods or services related to that variety, or where such use would be liable to cause confusion or association with it; or
15. are contrary to law, morality, public policy or proper practice.

Notwithstanding provisions of subparagraphs (b), (e), (f), (g) and (h), a sign may be registered as a mark if the person applying for registration, or his principal, has been making constant use of it in the member country, and where the effect of such use has been that the sign has acquired distinctiveness in relation to the goods or services to which it has been applied.

 

4. How can patents and trademarks be revoked?

Once registered before SENAPI, trademarks have a 10 year validity. If not renewed, the trademark expires.

Also, a third-party could request the cancellation of the brands that are in disuse and do not fulfill their function of distinguishing a product or service in the market through an administrative process named “Acción de Cancelación”.

 

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

Only when they are claimed within the deadline for an application in Bolivian territory.

 

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

Unfortunately, if trademarks are not registered before SENAPI and products are not registered before AGEMED, its unlikely that medicines and devices are protected otherwise.

 

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

Every patent or mark application must fulfill the limitations established in the Andean Community Decision No. 486 which establishes the Common Industrial Property Regime and also International regulations for pharmaceutical and biotechnology arrangements.

Regulatory authorities require data from preclinical and clinical trials to be able to approve and certify that a pharmaceutical technology is safe and effective for consumer use before market entry. Regulatory data protection arrangements allow regulators to access those data on the understanding that they will not disclose it. At the international level, regulatory data protection is governed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO). Article 39.3 of TRIPS requires WTO members to protect test data submitted to regulatory authorities against unfair commercial use and disclosure, except when the public interest so requires or when the data is otherwise protected against unfair commercial use. Protection of proprietary rights to drug registration data became a requirement for all WTO members, with the exception of least developed countries, from January 1, 2000, but many countries have yet to implement it.

 

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

Yes, and must fulfill all the local formalities to be registered by SENAPI in Bolivia.

 

Also from this Legal Handbook

The ins and out of product liability in Bolivian pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99

 

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

Civil liability occurs when an individual or a legal entity causes harm to another. Given the event, the aggrieved party must claim the reparations for the compensatory damages caused. The complaint must be filed before a judge claiming the reparations proving the existence of these premises:

1. Harm triggering event;
2. The offender ́s assignability;
3. Damage sustained by the aggrieved party;
4. Causal link between the triggering event and the damage caused to the aggrieved party.

If the aggrieved party correctly proves premises and they are not contested or denied, the Judge will order the reparation of the compensatory damages caused by the individual who caused the harm to the aggrieved party. The reparations will grasp the damages caused and the lost profit generated from the harm caused.

 

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

Administrative and civil responsibility is applied to the company while penal responsibility is applied to the company’s legal representative.

 

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

Laboratories are responsible for the quality of the products. Therefore, they are responsible through their legal representatives to assume all claims and costs due to any claims, adverse effects, etc.

 

4. How can a liability claim be brought?

The Civil Liability occurs when an individual or a legal entity causes harm to another. Given the event, the aggrieved party must claim the reparations for the compensatory damages caused.

The complaint must be filed to a Public Civil Judge, claiming the reparations proving the existence of these premises:

1. Harm triggering event;
2. The offender´s assignability;
3. Damage sustained by the aggrieved party;
4. Causal link between the triggering event and the damage caused to the aggrieved party.

If the premises are correctly proved by the aggrieved party and they are not contested or denied, the Judge will order the reparation of the compensatory damages caused by the individual who caused the harm to the aggrieved party. The reparations will grasp the damages caused and the lost profit generated from the harm caused

 

5. What defenses are available?

In the event of a Civil Liability complaint is filed, the claims of the civil liability must be detracted by undermining the presence of the premises noted above. Mainly, point 4 must be detracted, demonstrating that there is no direct relation between the triggering event and the damage caused.

 

Also from this Legal Handbook

Bolivian regulation regarding traditional medicines and OTC products. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99

 

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

 

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

Yes, they can with previous authorization of the authority.

 

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

Regulations state that these affirmations must be exact, true, informative, updated, and be able to be proven. Words like “better”, “more potent”, “has no side effects”, “security” and “harmless” cannot be used.

 

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

In order to be over the counter drugs, they must be included in the list provided by local authorities.

 

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

There are no specific limitations, the law states that products must be sold by pharmacies, popular pharmacies and drugstores.

 

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

If patients have adverse effects at any time, they can notify either the company or local health institutions.

 

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

Medicines can be sold in pharmacies, drugstores, popular pharmacies, etc. In respect to advertising they can be promoted through TV, radio, press, public spaces etc but need previous analysis and authorization of authorities

 

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

One of the attributions of the Pharmacologic Commission is to counsel in the elaboration and revision of the list of medical products that are sold over the counter and products that need prescriptions. Therefore, this commission is the one authorized to make any eliminations or inclusion in the lists.

 

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

In order to import any kind of medical products, the companies must be registered before the Health Agency (AGEMED), complying with all information and documents from the manufacturer. In these documents. information such as products, validity, and legal representation must be included.

Documents such as the ones listed below must also be presented:

• Health Authorization Certificate
• Quality Control Certificate issued by manufacture for each lot/batch to be imported.
• Copy of power of attorney.
• Origin invoice that includes lot and expiration dates
• Certificate issued by the health institution in the country of origin

 

Also from this Legal Handbook

All you need to know about Marketing, Manufacturing, Packaging & Labeling, Advertising in Bolivian pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99.

 

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

The first step in order to obtain the corresponding authorization to commercialize products in Bolivia is to go through the evaluation and qualification of the products efficiency and security. If this is met the Pharmacological Commission authorizes that the authorization process continues. Once authorization of the product is met and therefore authority gives a heath registration number (registro sanitario), sampling and quality control phase must be met.

 

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

Under law, only generic pharmaceutical can be promoted through massive communication (television, radio, press, public spaces, etc.). All marketing information must be previously authorized by the public institution. Non generic pharmaceuticals can only be promoted amongst doctors and health professionals.

 

3. What are the typical fees for marketing approval?

Costs will vary. It´ll depend if they are imported products or locally manufactured. Therefore, costs can be between US$ 300 and US$ 140.

 

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

Under law, it can take up to thirty business days. In practice it takes around 6 months.

 

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

Patients can notify pharmacies of any adverse effects. The professional must fill out a form and immediately inform the Departmental Pharmacovigilance Center.

 

6. Are foreign marketing authorizations recognized?

Only in the case of cosmetics and when they are members of the Andean Community.

 

7. Are parallel imports of medicines or devices allowed?

They are permitted if deemed necessary and exceptional in order to facilitate a rapid import and commercialization of products.

 

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?

Bolivian law states that any gifts, sponsorships, consulting agreements, trips, entertainment and other benefits must be informed previously. Any receptions or hospitality gestures as well as gifted made to health professionals must occupy a secondary objective of the conference, meeting, etc. and must be modest.

 

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

Product manufacturing is regulated under Ministerial Resolution No. 0296 dated June 2, 1996 and is regulated by the State Agency (Agencia Estatal de Medicamentos y Tecnología en Salud –AGEMED).

 

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

Yes, they are compatible.

 

11. What is the inspection regime for manufacturing facilities?

It’ll depend of the authority’s objective. They can be either:

1. Frequent: making sure that Good Manufacturing Practices are complied with.
2. Concise: in order to verify a specific aspect.
3. Follow up: making sure that observations were complied with.
4. Special: aleatory.

 

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

These inspections are not required by local law. Therefore, if companies are open to them, they must state so in their internal procedures.

 

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

The basic elements in order to comply with Good Manufacturing Practices are:

• Personnel
• Infrastructure
• Equipment and materials
• Documentation
• Materials, packages and labels
• Returned products
• Product recalls
• Transportation
• Claims

 

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

The information that must be included for medical products:

a. Primary packaging:

• Commercial name
• Generic name
• Principle components
• Pharmaceutical means
• Lot/batch number
• Expiration date
• Content
• Name of manufacturer or licensee
• Instructions

b. Secondary packaging

• Commercial name
• Generic name
• Pharmaceutical means
• Instructions
• Health registration number
• Expiration date
• Prescription
• Conservation and storage conditions
• Therapeutic action
• Dosage
• Warnings
• Instructions of preparation
• Name of manufacturer or licensee
• Manufacturer country of origin
• Labels

Labels for medical devices must contain:

• Commercial name
• Lot/batch number
• Expiration date
• Name of manufacturer or licensee

 

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

 

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

Because authority must review and authorize labels and packing, any information not required by law will be revised and approved by the authority.

 

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

In order to commercialize and distribute products in Bolivia, products must have the corresponding health registration number (registro sanitario).

 

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

Medical products must be handled and disposed by health professionals under their responsibility. Products can be sold in pharmacies, drugstores and other stores authorized to do so.

 

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

Although there is no specific regulation in this respect, the health authority includes this type of advertising as marketing directed for public in general and therefore must meet said requirements.

 

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

Only specific products can be sold directly to the public. For example for cancer treatment. In order to do so, the company must have special authorization.

 

21. How is compliance monitored?

AGEMED revises all documents and information in order to verify that the company is complying with all regulations. If not, AGEMED will ask the company to provide additional information/documents or amend them. Also, AGEMED can randomly inspect pharmacies or company’s warehouse to make sure that law is complied with.

 

22. What are the potential penalties for noncompliance?

Possible sanctions can include monetary sanctions as well as temporary closings or confiscation of products in the market.

 

Also from this Legal Handbook

Preclinical and Clinical Trials in Bolivia – an overview. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99.

 

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

No, it’s not a set condition. Studies issued by other countries are accepted.

 

2. How are clinical trials funded?

The interested party is responsible for financing the studies.

 

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

All protocols must be issued and presented in Spanish including these basic pieces of information:

1. Summary
2. Index
3. General information
4. Justifications and objectives
5. Type of study
6. Statistic analysis
7. Selection of target
8. Description of treatment
9. Study development and evaluation of response
10. Adverse reactions
11. Ethical aspects.
12. Practical considerations
13. Annex I Data recollection
14. Annex II Investigators Manual
15. Annex III Standard Procedures
16. Annex IV Analytical information of the samples to be utilized

 

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

The basic information that must be provided to them are:

1. Objective
2. Methodology
3. Treatment to be administered.
4. Benefits expected.
5. Risks
6. Adverse reactions.
7. Alternative treatments that are available.
8. The possibility to retire from the study in any phase of the treatment.
9. Information of the people that will access to the patient’s information.
10. Economic compensation and treatment in case any harm during the treatment.
11. The investigator that will be conducting the study.

 

5. May participants in clinical trials be compensated?

Yes, they can be economically compensated.

 

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

Before the study is initiated the promoter must have an insurance in favor of the patient.

 

Also from this Legal Handbook

An overview of the regulation, pricing and reimbursement of drugs in Bolivia. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99.

 

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

In Bolivia the authority that regulates all matters is the State Agency for Medical Products and Health Technology (Agencia Estatal de Medicamentos y Tecnología en Salud -AGEMED-y el Ministerio de Salud dependent of the Health Ministry).

 

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

There is no specific norm that regulates price fixing for medicines or medical products. All other aspects are regulated by Law No. 1737 (Medicine Law), Supreme Decree No. 25235, and other ministerial resolutions that regulate all aspects concerning the sanitary registrations, authorizations, imports, etc.

 

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

 

4.What are the approximate fees for each authorization?

In order to obtain authorization for an imported pharmaceutical (medicine, drug, or other) the costs are around US$ 300 while a local pharmaceutical US$140. For an imported generic product, costs can be around US$ 230 while a local one US$ 115.

 

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

Authorizations (registros sanitarios) once issued are valid for a five-year period. Under Bolivian law, renovations must follow the same procedure as if the company wants to register a new product.

 

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

Yes, there are certain differences between them. For example, in order to be able to distribute and commercialize generic products in the country, they must be included in a list that is issued by the authority and can proceed to obtaining the authorization directly. The other products must previously be authorized by the Department of Quality Management, Efficiency and Safety and then be able to solicit the products´ authorization.

The main difference between local and foreign manufacturers lies in the requirements that they need to present before the authority and the costs that need to be incurred by each of them.

 

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

Under Bolivian law, these products don’t have a special kind of regulation. Therefore, they are regulated like any other 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?

The public institution is in charge of making sure all regulations are complied with. They do so by asking companies to provide information, documentation and might even inspect warehouses and administrative offices.

 

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

Penalties can include economic sanctions, confiscation of products, to even cancelling licenses in order to import and/or commercialize products in the country.

 

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

Yes, Bolivia has a National System of Health which is composed of entities, institutions and organizations both public and private that provide health services, which are regulated by the Health Ministry. In the public sector, the Health Ministry is in charge of regulating and conducting all national policies and strategies. By doing so, all employees can access health care and treatments. In the private sector it is composed of insurance companies, prepaid health companies and nongovernmental organizations. In way of traditional medicine which is widely used in the country, on March 8^th, 2006 a special sub-ministry was created in order to facilitate indigenous populations, afro communities amongst other communities. The public sector is finances by the government while the employees’ sector is financed by both the employees and employers. The private sector is financed by them.

 

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

The sectors work independently. There might be cases where they work together in public tenders where public institutions buy private medications.

 

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

No, prices are not regulated.

 

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

All drugs and devices used by patients must be paid by each patient. Nonetheless, under Bolivian labor law, employees should be affiliated in a public health fund and receive medical services. In this case, there are some medicines and devices that are included in these services. Employers must make monthly contributions in order to cover costs.

 

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

The distribution must be made by a qualified pharmacist. Because they are hired as an employee, they receive a monthly salary.

 

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?

A professional in charge of medication dispensation or distribution must hold the highest ethical principles since a patient’s health and life is in game. Therefore, they have civil and even penal responsibilities against them.