I INTRODUCTION

The pharmaceutical industry in Latin America has historically represented a great challenge as its diversity is part of the rules of the game. Many actors in the life science sector have had to decipher such diversity to be able to penetrate these markets successfully, since it is not only based on different social, economic and political models, but also in heterogeneous legal systems. Consequently, the objective of this chapter is to drive the reader into understanding the complexity of the continent in terms of its regulations as well as the structure of its markets, main stakeholders, the challenges we have found in our practice and its normative evolution in recent years. This year's edition has some extra lines on the growing importance of the commercialisation of biological and biosimilar products in Latin America.

Though thorough, this chapter constitutes a summary of the most relevant aspects regarding life science in Latin America, and even includes some countries that do not have their own chapters in this publication.

II OVERVIEW OF THE REGION2

If we take as a reference for life science the global pharmaceutical market (global medicine spending), it currently exceeds US$1,000 trillion. Interestingly, 40 per cent of this amount corresponds to North America (the United States and Canada), while Europe has nearly 25 per cent of the total world market. Asia comes next with approximately 17.5 per cent.

In this global context, Latin America's share is between 7 per cent and 8 per cent of global drug spending, a figure that, taken as a whole, may seem insignificant, but from a market perspective, reflects a continent whose growth potential is extremely attractive, but equally challenging because of its diversity and complexity.

One of the first things to take into account to be able to decipher this region is that, within the total life science market in Latin America, Brazil and Mexico are particularly relevant because they are the countries with the largest population in the continent; hand in hand with this, they have the greatest economic potential. Both countries represent approximately 60 per cent of the total life science market in Latin America, so it would be unfair not to start this chapter by dedicating a few words to these two players.

Brazil currently has a population of approximately 210 million, and is likely to represent a percentage close to 45 per cent of the total Latin American market, with a growing economy, particularly in the life science market. Many of the world's leading stakeholders in the health sector have had a direct presence in Brazil for several years, and they measure the market signals with great rigour owing to their importance and complexity. However, getting a company in the life science sector to enter the Brazilian market and achieve a reasonable market share can take many years, depending on the commercial strategy chosen. On the other hand, as we will see later, the country is also very active regarding the enacting of new laws on life science, so acquiring an accurate understanding of the local reality is quite essential.

Mexico, the second-biggest country in the region, has a population close to 130 million and a market share in Latin America of approximately 15 per cent. Its operating costs are especially competitive compared with other markets and the inorganic growth (mergers and acquisitions) of its enterprises has played a predominant role in the past five years. The positioning, growth and expansion strategy for the different actors is probably different from that which might apply to the Brazilian market, but it also has material legal challenges to face.

Another particularly relevant country that deserves special treatment is Venezuela, which has a market share in Latin America of approximately 17 per cent, but also an especially complex economic and political reality in which many of the life science sector players have had to limit their investment and growth intentions. Following the same order of ideas, the legal challenges in the country are no less complex, and the institutions related to life science currently operate in a rather irregular manner. All these factors make Venezuela a highly important territory in terms of market size, but unfortunately it is also unattractive because of its current economic, political and social situation. The outlook is for a clear downward trend in the years to come as a result of the scarcity in the market and the lack of interest from investors in continuing their activities in the country. Hyperinflation in Venezuela rather distorts the macroeconomic figures and statistics on which we have based our assertions.

Argentina, with approximately 44 million inhabitants, shares a considerable 10 per cent of the total life science market in Latin America and, for the past few years, its economy seems to have been stabilising as a consequence of the change in the economic and political model. Therefore, the life science sector here also promises organic growth.

Life science markets in the rest of South America have also shown growth rates ranging from 1 per cent to 4 per cent per year, as is the case in Colombia, Ecuador, Peru, Chile, Bolivia and Uruguay. These smaller markets also have common business challenges, but radically different legal barriers.

Finally, there are the Central America and Caribbean markets, with a rather particular business model, where many international companies have an indirect presence and mostly operate through local distributors. These countries represent approximately 4 per cent of the total Latin American market. Nevertheless, it is an equally diverse and complex territory within the life science industry, where the realities of one market could be quite different to another.

III THE REGULATORY REGIME

As in other parts of the world, the regulatory regime in Latin America is increasingly rigorous, and the requirements from the local authorities differ from country to country. This aspect is material for the strategy of any company that intends to access the Latin American market.

The regional reference regulatory authorities for Latin America, qualified by the Pan American Health Organization (PAHO) and the World Health Organization (WHO), are the Colombian National Food and Medicine Surveillance Institute (INVIMA), the Brazilian Agency for National Health Surveillance (ANVISA), the Argentinean National Administration of Food, Drugs and Medical Technology (ANMAT), the Mexican Federal Commission for the Protection against Sanitary Risks (COFEPRIS), and the Cuban Centre for the State Control of Medicines, Medical Equipment and Devices (CECMED).

Some health authorities officially recognise marketing authorisations issued by health authorities of countries where medicine regulatory agencies have been certified as level IV by the PAHO, as well as those marketing authorisations issued by health authorities of certain countries, particularly the United States, Canada, Australia, Switzerland, Japan and the European Medicines Agency (EMA). However, special requirements may apply for biotechnological or biosimilar medicines and biological products.3

The participating members of the Central American Technical Regulation RTCA 11.03.59: 114 are the Ministry of Health and Social Assistance of Guatemala, the Superior Council of Public Health and the Ministry of Public Health and Social Assistance of El Salvador, the Secretariat of Health of Honduras and the Ministry of Health of Costa Rica. The purpose of the RTCA is to establish the conditions and requirements for the marketing authorisation of medicines for human consumption. It applies to medicines manufactured or imported by natural or legal persons for commercialisation in the Central American territory (it does not include compounded medicines).

Even in Latin America there are some agreements for mutual recognition of marketing registration (e.g., between Panama and Mexico); nevertheless, in practice they are not fully honoured. Similarly, in Central America, a reciprocity agreement provides for acknowledgement in all the countries in the region of a product that has completed some of the stages of manufacturing (not necessarily the entire manufacturing process) and obtained the relevant marketing authorisation in one of those countries.

Based on the above, we consider that the optimum strategy for obtaining marketing authorisation in Latin America is to begin with the most complex countries (for instance, Venezuela, Ecuador, Brazil or Argentina, in South America; and Panama, the Dominican Republic, Guatemala or Honduras, in Central America). In the case of Brazil, for example, the first requirement is the qualification by ANVISA of the manufacturing plant of the relevant products, regardless of its location, which considerably lengthens the time required to complete the formalities. We also recommend studying those cases where any change in an existing marketing authorisation ultimately implies the processing of a new marketing authorisation (for example, Ecuador).

Regarding the renewal of marketing authorisations, some health authorities are particularly stringent. This is the case of INVIMA in Colombia, which is characterised by its special rigour and high standards. Hence, we suggest your strategy should also be term-based.

Among the many new developments in Latin American legislation on life science, the Regulation for Medicine Interchangeability in Peru, issued through Supreme Decree No. 024-2018-SA, will come into force in March 2019. It provides, among others, the acknowledgement of in vitro and in vivo therapeutic equivalency studies carried out and approved by institutions certified or authorised by the EMA, the US Food and Drug Administration, Health Canada, the Spanish Agency for Medicines and Health Products, the UK Medicines and Healthcare Products Regulatory Agency, the Swedish Medical Products Agency, the Swiss Agency for Therapeutic Products, ANVISA, WHO and bodies from other countries with high health vigilance standards. This Regulation is very relevant because countries such as Peru are accepting and taking over the work of international bodies, which is likely to become a trend in the coming years.

The increasing importance of biosimilar products during the past few years must also be mentioned. Biosimilar drugs are:

. . . products of biotechnological origin [that] are similar in structure, function, and clinical use as their 'reference' biological medicines. Biosimilars are a new step in biological drugs, they are very similar to the reference biological products and are obtained using new cellular sequences, so that they are similar, but not exactly identical to the reference products.5

For some time now, ANMAT, ANVISA and COFEPRIS have produced their own abbreviated regulations for these products, which are a combination of the biosimilar standards of WHO and the EMA, and their own political and economic requirements.6

As evidence of this increasing importance of biosimilar products, it is sufficient to look at the number of marketing authorisations approved by the Latin American regulatory agencies, mostly in countries such as Mexico and Brazil, and in smaller markets such as the Central American countries, where the pharmaceutical industry has started to mark its territory. Nevertheless, along with the development of this market arises the need for a harmonious legislation, starting with elementary subjects such as nomenclature. The great challenge Latin America faces is to develop regulations fit for international application, as it has done in the case of intellectual property, for instance.

IV PRICING AND REIMBURSEMENT

i Price control

The above-mentioned legislative diversity in Latin America applies equally to medicine price control in certain countries of the region, while in others such control does not exist, leading to significant differences in the cost of medicines from country to country.

Ecuador, Brazil, Argentina, Colombia and Venezuela have medicine price regulatory entities in place.

Ecuador

The General Regulations for Pricing of Medicines for Human Consumption were published in the Official Gazette on 1 June 2011. This regulatory framework aims to regulate the pricing procedures for medicines marketed within Ecuadorian territory.7

The National Pricing Council for Medicine for Human Consumption is the entity in charge of fixing and reviewing medicine prices for sale and commercialisation throughout Ecuadorian territory. Medicine pricing is a fundamental requirement for medicine commercialisation throughout the national territory.

According to Article 19 of the aforementioned Regulations, the following criteria apply to pricing: (1) for companies requesting dealer pricing, including a 10 per cent mark-up for the dealer, the relevant auditing company should certify that the requesting company has deducted from its operating expenses the total amount delivered to the distributor whether in cash, in kind or in any other form whatsoever; and (2) for companies that do not request dealer pricing, a maximum 10 per cent will be accepted as part of operating expenses for bonuses and promotions regarding net sales income of the total amount submitted to the distributor, to cover the mark-up.

The commercial cost will be calculated on the actual costs and expenses incurred in the product, plus a percentage of operating expenses on the cost of sales for the last fiscal year, as duly audited.

Colombia

The Technical Secretariat of the National Pricing Commission for Medicines and Medical Devices, through the Integrated Medicine and Medical-Surgical Supply System (SISMED) is the regulatory entity for the control of certain medicines for human consumption in Colombia.8 Circular Letter 03 of 2013 establishes the methodology for the application of the direct price control regime for medicines traded in the territory. This methodology consists of four stages as detailed in the circular letter: (1) definition of the relevant market; (2) measurement of its concentration degree; (3) reference pricing; and (4) administrative fixing of the maximum sales price of medicines, if applicable.

On the basis of commercial integration, geographic proximity, similarity in the general economic intervention degree, membership of the Organisation for Economic Co-operation and Development, and information availability criteria, reference countries for the Colombian authorities are Argentina, Brazil, Chile, Ecuador, Mexico, Panama, Peru, Uruguay, Spain, the United States, the United Kingdom, Australia, Canada, France, Norway, Germany and Portugal. The International Reference Price is calculated with consideration of the relevant information from all these countries, if available; otherwise, only those countries which information is available will be included in the calculation.

Brazil

The Executive Secretariat of the Medicine Market Regulation Chamber (CMED) is the inter-ministerial body in charge of regulating the medicine market and establishing the pricing criteria thereof.9 It works hand in hand with the Agency for National Health Surveillance (ANVISA). If a new product is acknowledged as having strong evidence of superiority over the standard therapy available, external reference prices should apply. If the CMED does not see any significant advantage compared with existing therapies, the new product will have a price comparable to the therapy. The group of countries taken as a source for price reference is made up of Australia, Canada, France, Greece, Italy, New Zealand, Portugal, Spain, the United States and the country of origin. The price of the new medicine in Brazil will equal the lowest among the reference countries. The group will be changed in the near future, removing Greece and New Zealand and including a Latin American country. With regard to the above, here is a passage from the fifth edition of The Life Sciences Law Review:

Given the complexities of the Brazilian healthcare system and considering that the government is the main purchaser of healthcare products and services, it is key that these be provided in an accessible and low-cost fashion. That being so, the government intervenes in the market by controlling prices and imposing mandatory discounts for medicines. Within this context, the ANVISA Drugs Chamber (CMED) is in charge of controlling the price for certain medicines in Brazil. After a given medicine is approved and registered by ANVISA, the marketing authorisation holder must obtain CMED´s approval for the respective price, before launch. The CMED-approved price is the maximum sales price in the private market. In any case, CMED also defines the final price for consumers and for the public market based on certain rules. Therefore, there is a price cap effective for suppliers and distributors in Brazil.10

In the case of Central America and the Caribbean, it is important to make particular note of the regulations of El Salvador, Honduras and the Dominican Republic.

El Salvador

Decree No. 1008 of 2 March 2012 contains the Medicines Law that defines the parameters to establish the mark-up. The maximum consumer price should be determined based on the International Reference Price establishing different mark-ups for innovative or generic medicines manufactured in or imported to the country.

The mark-up will be between three and five times the International Reference Price for each product according to the parameters of the WHO, but in no case should it exceed the average price of the Central American area and Panama, therefore becoming the maximum consumer price. To establish the reference price, the National Medicines Direction will compare the prices of medicines offered by pharmaceutical chains of the same level in Central American and Panama. Generic medicine prices should be 30 to 40 per cent lower than the prices of innovative medicines. Authorized over-the-counter medicines are excluded from this regulation.

To determine the maximum consumer price of medicines, homogeneous groups are identified for price comparison with reference prices – the International Reference Price and the Average Price for Central America and Panama. The lowest of all will become the maximum consumer price. Medicine pricing is the responsibility of the Price Unit of the National Medicine Direction, and the enforcement thereof is the responsibility of the Inspection and Surveillance Unit, in coordination with the Consumer Protection Authority. Article 43(b) of the Consumer Protection Law qualifies selling goods or services at prices higher than those sanctioned by law as a serious offence, subject to a fine of up to 200 urban monthly basic minimum wages for the industry.

Honduras

Decree No. 65-91 of 28 May 1991 contains the Health Code for the Republic of Honduras. Its Article 134 (which was drafted in the terms of Decree No. 191-91, dated 11 December 1991, published in the Official Gazette No. 26659 of 3 February 1992) regulates medicine price control through the Secretariat of Economy and Commerce. It sets forth that the maximum percentage of gross profit in the sale or supply of pharmaceutical products will be determined based on the CIF price, in the case of products manufactured domestically. The aforementioned rule also indicates that the profit margin on the sale of generic products may be different from that established for the sale of commercial products under a trademark.

The gross profit on the sale or supply of pharmaceutical products by hospitals or private polyclinics to patients receiving medical treatment should not exceed 25 per cent of their cost; it is mandatory to issue a detailed invoice for the medicines for verification purposes.

Finally, although discounts to medicine prices are not regulated, they must adhere to the provisions of the Competition Defence and Free Promotion Law (Decree No. 357-2005).

Dominican Republic

Law No. 13 of 1963 states that medicines are essential items, and delegates their pricing to the Ministry of Public Health and Social Assistance (MISPAS). In practice, the regulations on this matter are not being enforced and, therefore, there is no updated or standardised price control. The only existing regulation that governs this aspect is the agreement executed in February 1972 by MISPAS, the Association of Representatives, Agents and Producers of Pharmaceutical Products, and the Association of Pharmacy Owners, which provides the following margins:

  1. laboratory sales price (LSP): freely established by the producer;
  2. distributor sales price (DSP): according to a domestic market survey, or the LSP plus 25 per cent if the distributor does not promote the drug, or the LSP plus 40 per cent if the distributor promotes the medicine, or the LSP plus 33.3 per cent when promotion costs are shared; and
  3. retail price (RSP): DSP plus 30 per cent.

ii Advertising and promotion

As a general rule, public advertising of prescription pharmaceutical products is forbidden in virtually all the countries of Latin America, although enforcement is more rigorous in some countries than in others. In many cases, any promotional material for prescription medicines requires the approval of the regulatory authority. For this reason, before carrying out promotional activities for ethical products, the internal legislation for each country must be carefully reviewed to identify the requirements that the promotional material must meet. In general, these requirements are quite similar, and are contained and summarised in deontological codes such as the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code, or 'Business Principles for Promoting Integrity in the Pharmaceutical Sector in Latin America', recently published by Transparency International.11

As a general guideline, advertising of ethical products is acceptable if it meets the following criteria:

  1. phrases or words such as 'wonderful', 'magical', 'infallible', 'insurmountable', 'the most effective' that exaggerate the benefits of the products should not be included as they may imply unfair competition;
  2. the information contained in promotion and advertising materials must be based on verifiable scientific evidence, accurate, reliable and not abusive of the good faith and credulity of people;
  3. the advertising message cannot threaten a person's dignity or violate ethical values;
  4. the advertising message must avoid any form of violence or discrimination;
  5. the promotion or advertising should not use expressions that may cause fear or anguish or suggest that health may be affected by not using the medication;
  6. advertising must contain accurate, balanced, honest information and it should be complete enough to allow the recipients the best choice for their clinical needs;
  7. advertising must be disclosed in Spanish, in clear and easily understandable terms for the target audience;
  8. statements or testimonials of users of the product that do not match the therapeutic indications approved in the registry thereof should not be included;
  9. the name and characteristics of the advertised medicine must be the same as those found in the actual product registry with the relevant authority;
  10. the advertising nature of the material and the name of the subject matter product should be evident;
  11. invitation to read carefully the instructions that appear in the indications of the medication should be express and clearly visible; and
  12. the advertising message should include the phrase, 'Consult a pharmacist or a physician in case of any doubt' or a similar expression.

In many countries, the direct or hired dissemination of misleading or false advertising is considered a serious offence, and is often regulated by both the health legislation and consumer protection laws.

V TRANSACTIONAL AND COMPETITION ISSUES

Latin America has not developed specific legislation on free competition exclusively focused on life science. Notwithstanding the above and considering that the subject of health is very sensitive, particularly from a political point of view, the legislation on free competition in countries where there is no price control becomes especially relevant and has gained prominence in the region during the past decade. For instance, in the famous Pharmacies case in Chile (2008–2012),12 in which the top three pharmacy chains in the country were charged by the National Economic Prosecutor's Office with agreed increase or collusion to increase the price of 222 medicines, mostly for chronic diseases. The prices offered by the pharmacies exceeded those of the national supply office (Cenabast) by up to 3,000 per cent. In the end, two chains were sentenced by the Free Competition Defence Court to pay a fine for the maximum amount allowed by the law in force at that time (an amount close to US$19 million each), which constituted a major a milestone in Chile.

A similar case occurred in Peru in 2016, in which the National Institute for the Defence of Free Competition and Protection of Intellectual Property13 penalised in the first administrative instance five pharmacy chains for agreeing on prices for medicines and nutritional supplements. Additionally, the Commission for the Defence of Free Competition instructed the five chains, as a corrective measure, to implement a three-year programme that aimed to avoid the recurrence of antitrust behaviour. This conduct is categorised in Article 11.2 of the of the Anti-Trust Behaviour Law.

VI CURRENT DEVELOPMENTS

i Interaction with health professionals

Based on our experience, we can ascertain that the interaction with health professionals in the life science field is increasingly relevant not only for pharmaceutical laboratories, but also for the authorities of the region. In this sense, in recent years we have seen interesting legal reforms of which the main focus has been to ensure an ethical and transparent interaction between life science-related companies (especially pharmaceutical companies) and health professionals.

For example, the Colombian legislation has a considerable number of regulations related to interaction with health professionals, on which subject INVIMA plays a fundamental and active role. Additionally, Law 1438 of 201114 regulates physicians, health professionals and the healthcare industry. Article 106 prohibits pharmaceutical companies and other health-related entities from offering and providing any incentive or other rewards, either in cash or in kind, to any doctor or public or private health professional, or any employee or entity of the social security system, except when the delivery of such incentive or reward is provided under a contract executed by the health-related entity and the beneficiary. Fines may apply to companies or institutions that do not comply with these provisions.

In El Salvador,15 the pharmaceutical laboratories, drugstores and pharmacies are prohibited from granting or offering directly or through third parties, any gifts, commissions, bonuses, cash payments or any other type of royalties or incentives whatsoever, directly or indirectly to doctors, dentists, veterinarians, shop assistants, managers, employees of public and private institutions or owners of drugstores or pharmacies, in compensation for prescription, dispensation or retail sale of their products on a preferential basis.

In addition, the representatives of associations of pharmaceutical laboratories, pharmaceutical chemists, distributors of pharmaceutical products, laboratories, drugstores, pharmacies, law firms, the Central American Federation of Pharmaceutical Laboratories, the National Direction of Medicines, and the President of the Surveillance Board of the Pharmaceutical and Industrial Chemical Profession have executed the Self-Regulation Agreement for Ethical Practices in the Distribution and Dispensing of Medicines, whereby they undertook to avoid unethical practices regarding medicine advertising and promotion, committing not to directly or indirectly offer any type of incentive, discounts, bonuses, premiums or gifts made by those who have direct or indirect interest in the production, manufacture and marketing of medicines, to health professionals, with the purpose of promoting the prescription, dispensation and administration thereof. The signatory parties of the Agreement are committed to create corrective mechanisms to allow the rectification of any improper behaviour according to the provisions of the Medicines Law.

In this sense, public health professionals are also bound by the Government Ethics Law, which prohibits them from requesting or accepting, directly or through a third party, any goods or services of economic value or additional benefit to those received for the performance of their work. A public officer is prohibited from receiving benefits other than those he or she is entitled to receive by law, and must adopt the necessary measures to avoid any reasonable doubt about the legitimacy of his or her income and patrimony.

In line with the above, Article 228 of the Guatemalan Health Code16 establishes as infractions against health, among others:

8. Giving or offering economic or material benefits to the owners or shop assistants of medicine distribution or sale centres, in order to have them influence the consumer to replace the prescribed medicine.
9. Receiving economic or material benefits by the owners or shop assistants of medicine distribution or sale centres, in order to influence the consumer to replace the prescribed medicine.

With regard to the Dominican Republic,17 sections 13 and 69 of Article 268 of Decree 246-06 prohibit the direct or indirect offer of incentives, bonuses and gifts by those who have interests in the marketing of medicines to those involved in the prescription, dispensation or administration thereof.

Although we have not identified a significant amount of legislation or express regulation on sponsorship to health professionals in Latin America, Argentina, through its Resolution 627/2007, allows pharmaceutical companies to sponsor health professionals to attend medical congresses and other scientific meetings in Argentina and abroad. However, in line with the above-mentioned IFPMA Code, many deontological codes prohibit companies from sponsoring offshore events, unless the venue is justified by security or logistics reasons (e.g., if most of the participants are foreigners). Hospitality in connection with sponsorship, including the payment of travel expenses, registration fees, accommodation and travel allowance, must be reasonable and limited to the days required to attend the event. Events must take place in places conducive to the scientific or educational objectives and the purpose of the event. Luxurious places should be avoided. The events should be focused on educational activities. Social and cultural activities should be limited to breakfasts, lunches, snacks or dinners. Entertainment or leisure activities, such as sporting events, should not be included.

VII CONCLUSIONS

The production of a brief review of the main issues regarding life sciences and the relevant regulations in Latin America is indeed a great challenge, as the continent is constantly evolving and its health authorities are increasingly prevailing. This is immediately apparent to anyone trying to obtain authorisation for marketing or promotional materials, facing pricing or market regulations, or interacting with healthcare professionals. The life sciences industry is highly regulated around the globe and new trends (e.g., compliance issues) are beginning to permeate this part of the world. A case in point is the regulatory evolution of biologics and biosimilar products, where international legislation should be applied rather than local or isolated constructs.

It is crucial for those who intend to enter the Latin American market to be able to discover and understand some of the key aspects developed in this chapter, which I expect to complement in future editions.


Footnotes

1 Felipe Coronel is founding partner at Latin Lex Consulting and Latin Lex International.

2 We have been able to obtain the statistics referred to in this chapter as a result of our participation in the boards of multinational companies with presence in Latin America. We have also obtained data from IMS HEALTH, including the publication, Dinámicas y perspectivas del mercado farmacéutico en América Latina (Dynamics and Perspectives of the Pharmaceutical Market in Latin America), written by Juan Manuel Santa Maria, a distinguished participant in the 2015 IMS World Review Conference.

3 For example, El Salvador: Decree No. 34, Special Regulation for the Acknowledgement of Foreign Sanitary Registries, published in the Official Gazette on 4 March 2013; Ecuador: Ministerial Agreement No. 586, Regulations for the Sanitary Registry of Medicines in General, published in the Official Gazette, Supplement 335 on 7 December 2010 (last amendment: 23 May 2016).

4 This document was approved by the Medicines and Similar Products Subgroup and the Standardization Subgroup as Central American Technical Regulation RTCA 11.03,59:11, Pharmaceutical Products. Medicines for Human Consumption. Requirements for Obtaining the Sanitary Registry. It was enforced through its ratification by the Council of Ministries for the Central American Economic Integration (COMIECO).

5 Latin American and Biological Similars, Executive Report of the Biologics and Biosimilars Policy Advocacy Summit, page 3, available at http://gafpa.org/wp-content/uploads/Excecutive-Report-Brazil-GAfPA-Summit-2017.pdf.

6 GaBI Online – Generics and Biosimilars Initiative. Regulation on similar biotherapeutic products in Latin America (www.gabionline.net).

7 Medicine price control in Ecuador has its legal basis on Executive Order/Decree 1290 for the creation of the Regulation, Control and Health Surveillance Agency (ARCSA), and the National Institute of Public Health Research (INSPI).

8 Medicine price control in Colombia has its legal basis mainly in Article 243 of Law 100 of 1993, Article 87 of Law 1438 of 2011, Decree 705 of 2016, and Circular Letter 03 of 2013.

9 Medicine price control in Brazil has its legal basis in Law 10.742, dated 6 October 2003.

10 Chi Kung, Angela Fan and Nicole Recchi Aun, The Life Science Law Review, Fifth Edition, published by Law Business Research, March 2017, 6hapter 6: Brazil, at p. 70.

11 For further information about this regulation refer to the International Federation of Pharmaceutical Manufacturers, www.ifpma.org, and Transparency International, http://ti-health.org/content/pharma-business-principles-latin-america/.

12 Case File C 184-08: Requirement from FNE against Farmacias Ahumada SA and Others. Free Competition Defence Court. Filed on 9 December 2008 by the National Economic Prosecutor's Office.

14 Law 1438, whereby the general social security system was reformed, including other provisions, was enacted on 19 January 2011.

15 Regarding El Salvador, we refer to the following regulatory bodies: Decree No. 1008, Medicines Law, Decree No. 245; General Regulation to the Medicines Law; Decree No. 776, Consumer Rights; Decree No. 417, Medicine Promotion and Marketing; Government Ethics Law and its Regulation.

16 Regarding Guatemala, we refer to the following regulatory bodies: Technical Regulation No. 39-2003, Medicine Marketing, Promotion and Information; Decree No. 90-97, Health Code; Decree No. 06-2003, Consumer Protection Law; Government Agreement No. 712-99, Regulation for the Sanitary Control of Medicines and Related Products; Regulation 53 of 2006, Advertising and Promotion of Related Products.

17 Regarding the Dominican Republic, we refer to the following regulatory bodies: Law 042 of 2001, General Health Law; Law 05 of 1988, medicines and controlled suwbstances; Law No. 68 of 2003, creation of the Dominican Medical Association; Law 340 of 2006, acquisition and contracting of goods and services and concessions; Decree 486 of 2012, creation of the General Direction of Government Ethics and Integrity; Decree 310 of 2005, Operating Regulations of the Ethics and Fight against Corruption Commission.