The Role of Patents in Latin American Development: 'models of protection' of pharmaceutical patents and access to medicines in Brazil, Chile and Venezuela

The Role of Patents in the Latin American Development: ‘Models of Protection’ of pharmaceutical patents and access to medicines in Brazil, Chile and Venezuela Access to medicines, pharmaceutical patents, and public health are topics often addressed in the news. On the one hand, there is an imperative need to tackle pressing health concerns, and on the other hand, it is also important to provide adequate incentives to carry out research and development. Even though common health concerns exist within the developing world, each country has a different set of needs. The approach to solve or the strategies to balance intellectual property rights and access to medicines vary at large. Latin American countries i.e. Brazil, Chile and Venezuela, even though geographically located in the same continent, deal with the challenges in a different and unique manner. Before the TRIPS Agreement countries had the freedom to decide on whether or not to grant patent protection for medicines. Thus, most of the developing and least developed countries, now WTO member countries, did not provide patent protection for pharmaceuticals because they feared that patent protection would increase the price of pharmaceuticals, and hence, become an obstacle for the access to medicines. On the one hand, patent protection represents an incentive for the pharmaceutical industry to carry out R&D for new and needed drugs. But on the other hand, patents, as the system of financing R&D, has been regarded as a flawed system due to the high costs transferred to the finalised product (medicine) thus deterring access to medicines. Patent protection allows the inventor to prevent others from making use, selling, producing or distributing the invention without his consent for a period of no less than 20 years. Moreover, these rights conferred by the patent grant seem to constitute the pharmaceutical industry’s incentive to recoup the high costs associated with the R&D of a new drug. This book reviews the strategies or models of protection used in Brazil, Chile and Venezuela to balance both intellectual property rights (pharmaceutical patents) and access to medicines. Each country seems to have shaped their policies in accordance with their national priorities, whether these are motivated by health, political or commercial issues. This study portrays the different approaches followed in different national contexts despite all three having to implement the minimum standards of intellectual property protection according to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). The outcome of the comparison of the policy implementations and the patterns followed by each of the analysed countries is without a doubt the main contribution of this academic study

Revising Current Incentives and Regulation for New Health Technologies

Regardless of the significant medical advancements and efforts in harmonizing intellectual property rights standards of protection, innovation and incentive mechanisms are needed more than ever to address new health threats and drug resistant -antimicrobial resistance (AMR). Recent outbreaks denoted the lack of preparedness countries face when dealing with health emergencies. Developing a vaccine for e.g. Zika and the access to this, points out the other factors related to access, e.g. affordability –price; and incentives for R&D. While patents are said to provide sufficient incentive to prompt R&D of new medicines or health technologies, this system has also been highlighted as the reason jeopardizing access to top of the line medicines due to high prices. This presentation reviews two important models currently use to prompt and finance R&D in the pharmaceutical sector - e.g. public private partnerships (PPP), and the EU Orphan Drug scheme. By revisiting these two particular trends it is expected to draw a few conclusions on the limits posed by regulatory incentives and the challenges to overcome by a new side system of incentives. The current model is failing for several reasons, among them because relying on patents and regulatory exclusivity is associated to pricing power (Abbott, 2018), which translates in unaffordable medicines. Thus, PPP come into the spotlight as a model to review in terms of incentives for R&D, and benefits to society. In terms of the EU Orphan Drug Scheme,1 its success in achieving innovation within the EU is based on the regularity incentives portrayed by it. Achieving Orphan Drug status represents an additional set of benefits for the pharma company developing the drug. For instance, 10 years of market exclusivity,2 speeder procedure to obtain the MA, additional aid to support drug development, and exemption of fees related to protocol among others. This designation, is not exempt from abuses, allegedly the pharmaceutical industry has used orphan drug designations strategically to gain position in the market both in the EU and US. (Nakov, et. al 2016, and Prescrire 2015), nevertheless, its regulation has allowed the pharmaceutical industry to foster innovation in a field where only a very low percent of the population is treated. Affordability, has been at the top of the discourse questioning the patent system (Cadillo, 2016, and HLP Report, 2016). The cost of R&D, and overall needed innovative medicines has been largely discussed in both in the USA and the EU. In 2018 the EU Expert Panel on Effective Ways of Investing in Health, prompts delinking R&D from sales and stressed the importance in finding alternative models to finance R&D for actually needed3 medicines and not the so call me-too drugs. Similarly, the Council of Economic Advisers from the United States, in a report revisited and questioned the correlation high prices vs innovation. Thereafter, concluding that “reducing American prices and stimulating innovation4” needed to be achieved. Clearly, delinking costs associated to R&D from the end price needs to be done. Thus, this presentation is a first step within a larger project (INHEALTH)5 to find alternatives that translate in plausible effective solutions to contribute with the current narrative

Revising Current Incentives and Regulation for New Health Technologies

Regardless of the significant medical advancements and efforts in harmonizing intellectual property rights standards of protection, innovation and incentive mechanisms are needed more than ever to address new health threats and drug resistant -antimicrobial resistance (AMR). Recent outbreaks denoted the lack of preparedness countries face when dealing with health emergencies. Developing a vaccine for e.g. Zika and the access to this, points out the other factors related to access, e.g. affordability –price; and incentives for R&D. While patents are said to provide sufficient incentive to prompt R&D of new medicines or health technologies, this system has also been highlighted as the reason jeopardizing access to top of the line medicines due to high prices. This presentation reviews two important models currently use to prompt and finance R&D in the pharmaceutical sector - e.g. public private partnerships (PPP), and the EU Orphan Drug scheme. By revisiting these two particular trends it is expected to draw a few conclusions on the limits posed by regulatory incentives and the challenges to overcome by a new side system of incentives. The current model is failing for several reasons, among them because relying on patents and regulatory exclusivity is associated to pricing power (Abbott, 2018), which translates in unaffordable medicines. Thus, PPP come into the spotlight as a model to review in terms of incentives for R&D, and benefits to society. In terms of the EU Orphan Drug Scheme,1 its success in achieving innovation within the EU is based on the regularity incentives portrayed by it. Achieving Orphan Drug status represents an additional set of benefits for the pharma company developing the drug. For instance, 10 years of market exclusivity,2 speeder procedure to obtain the MA, additional aid to support drug development, and exemption of fees related to protocol among others. This designation, is not exempt from abuses, allegedly the pharmaceutical industry has used orphan drug designations strategically to gain position in the market both in the EU and US. (Nakov, et. al 2016, and Prescrire 2015), nevertheless, its regulation has allowed the pharmaceutical industry to foster innovation in a field where only a very low percent of the population is treated. Affordability, has been at the top of the discourse questioning the patent system (Cadillo, 2016, and HLP Report, 2016). The cost of R&D, and overall needed innovative medicines has been largely discussed in both in the USA and the EU. In 2018 the EU Expert Panel on Effective Ways of Investing in Health, prompts delinking R&D from sales and stressed the importance in finding alternative models to finance R&D for actually needed3 medicines and not the so call me-too drugs. Similarly, the Council of Economic Advisers from the United States, in a report revisited and questioned the correlation high prices vs innovation. Thereafter, concluding that “reducing American prices and stimulating innovation4” needed to be achieved. Clearly, delinking costs associated to R&D from the end price needs to be done. Thus, this presentation is a first step within a larger project (INHEALTH)5 to find alternatives that translate in plausible effective solutions to contribute with the current narrative

Venezuela between dengue and chikungunya. Who can be held accountable for poor access to health?

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Equitable access to COVID-19 vaccine distribution:The case of the Andean Community

The COVID-19 pandemic has shown how equitable vaccine distribution still remains unaccomplished. While access to COVID-19 vaccines has been efficient in the EU, the Latin American situation is very different. For example, the Andean Community reports that, as of December 2022, 83% of the population had received at least the first dose of the vaccine while only 43% had received the third dose (http://www.orasconhu.org). Motivated by the challenges and successes endured by countries in the Andean Community vis-à-vis the EU during COVID-19 vaccine roll-outs, we analyse key legal, policy and management factors affecting vaccine equity. We are especially critical of the strategy followed in the Andean Community, namely, of increasing dependency on imports and donations instead of harnessing other more effective policies. We highlight the specific role of the factors identified in achieving coherent policy strategies and propose recommendations to promote equitable vaccine distribution in the Andean Community, and beyond

Law and Technology of 3D Printing and Medical Devices

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