TRIPS PATENT FLEXIBILITIES AND ACCESS TO HEALTHCARE AND INNOVATION (Research Paper Sample)

TRIPS PATENT FLEXIBILITIES AND ACCESS TO HEALTHCARE AND INNOVATIONHIV and COVID Table of Contents TOC \o "1-3" \h \z \u 1.Introduction PAGEREF _Toc58691277 \h 3 2.The Role of Flexibilities in Healthcare and the Medical Field4 3.Examples of Use of Exceptions in Healthcare PAGEREF _Toc58691279 \h 9 3.1.Case Study –HIV/AIDS Drugs in Kenya and Zimbabwe PAGEREF _Toc58691280 \h 9 3.2.India's Experience and Growth to the World's Factory for Generic Drugs12 3.3.South Africa - Judicial Approach Role in Access to Essential Medicine in Developing Countries PAGEREF _Toc58691282 \h 13 4.COVID-19 and TRIPS Flexibilities PAGEREF _Toc58691283 \h 14 5.The Danger of Reduced Research and Development PAGEREF _Toc58691284 \h 16 6.Conclusion PAGEREF _Toc58691285 \h 17 References PAGEREF _Toc58691286 \h 19 Introduction The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has a number provision referred to as flexibilities which were designed to enable member states, especially least developed countries, to design laws which empower them to increase the access of affordable healthcare to citizens. This was born from the realisation that medical patents can have adverse impacts on medicine, healthcare and social wellbeing of the people. Therefore, if patents are stringently protected, the negative impact would be that countries which cannot afford the high costs of medicine would not have access to medicine. Also, the costs of medicine and healthcare would be unimaginably high. There is no requirement for more extensive protection than what is required under the Agreement. Members are free to decide the proper methods for implementing TRIPS in their legal systems. They can draft procedures which achieve social objectives. Members are exempted from legal liability for the parallel importation process. The objective of these flexibilities is found in Article 7, which includes promotion of technology innovation, the transfer of technology, balancing the obligations and rights, and ensuring the mutual advantage of the users of technology and the producers, in a manner which promotes social and economic welfare. The flexibilities are aimed at ensuring public health measures and nutrition, and creating socio-economic and technological technology. The justification of flexibilities is well captured by the words of an Indian Judge who stated that ‘[A] right cannot be absolute. Whenever conferred upon a patent holder, the right also carries accompanying obligations towards the public at large. These rights and obligations, if religiously enjoyed and discharged, will balance each other. The slightest imbalance may fetch highly undesirable results.’ Otero Begona González suggests extensive use of flexibilities in dealing with COVID-19. Some of the concerns raised in the paper are compulsory and free licensing to ensure success in fighting the virus. She reflects that IP must be used as a support for the fight. This suggests drastic measures by international institutions and governments in fighting the pandemic. The public policy issue for such drastic measures is the severity of the pandemic. It not only has health impacts but also affects the socio-economic stability of countries. Patents affect healthcare access more than any other sector or aspect of human rights, and hence, the balance between patent protection and access to healthcare must always be ensured by governments. The debate for technology sharing in the wake of the COVID-19 pandemic has been taken up by the WTO. Already, India and South Africa have proposed a waiver from certain provisions of TRIPS, citing reasons of containment, treatment and prevention of the virus. Key issues raised by the two include intellectual property (IP) hindering the timely provision of affordable medicine and equipment for patients. Drastic changes have been made by different nations in their national laws to ensure that there is an expedited process of issuing government use and licenses. However, there are challenges and questions which have been posted. They include the extent of the flexibilities, the difficulties that member states will face concerning private rights and public rights, the limitations and benefits of voluntary licenses and pledges, and lastly, whether trade secrets can be shared broadly. The question remains whether the use of flexibilities can ensure access to healthcare. The Role of Flexibilities in Healthcare and the Medical Field There is an extensive commentary produced documenting the role of TRIPS flexibilities in access to healthcare. Low and middle-income countries are denied access to basic healthcare due to the high prices of drugs imported from developed countries like Europe and North America. Sometimes these drugs cost more in developing countries due to price differentiation. Flexibilities have been instrumental in rectifying such wrongs. The importance of TRIPS flexibilities in public health has been recognised by the United Nations (UN). All member states are discouraged from undermining them. Some of the examples which the UN recognises collaboration and use of flexibilities in the case of elimination of HIV/AIDS. One of the most essential provisions of TRIPS is allowing member states to determine the criteria for patentability. This allows the nations to have a criterion which is fair to their social well-being. Exclusion from innovation deemed to upset public order and morality can be included in patentability, hence preventing certain innovations which are essential for fair access to healthcare. It includes exceptions covering human, animal and plant life or environment; therapeutic, diagnostic and surgical treatment methods for animals and humans, animals and plants except for microorganisms, and the essential processes of biology for their production. Therefore, despite the requirement not to discriminate, countries can treat different technologies and situations differently. This differentiation takes the form of disclosure, patentability eligibility, the scope of protection and subject matter. Further, in terms of derivatives, the exclusion allows a patent to be rejected for products which have no significant improvements based on the policy rationale that trivial modifications are not inventive steps. This exclusion ensures that no methods of treatment or patent administration of drugs are patentable. This is the work of doctors. There is the exclusion of the new uses of a known product based on subject matter grounds. This allows countries to ensure that the patent laws are not restrictive. Hence, reduce the costs of drugs, for instance, by ensuring that modified drugs are not patentable. The best example is India. Under India’s Patent Act of 2005, section 3(d) creates a higher patentability standard for drugs. No new form or new uses, among others, of substances, is considered inventive or patentable unless there is a proven enhanced efficiency. This efficiency is not just a minor improvement. In Argentina, this standard is even higher. The law prevents any new form of known substances, whether they have enhanced efficiency. The patent examiner must reject new uses, forms, new formulations, minor changes and broadly defined claims. This ensures that extension of patents is reduced, hence ensuring that drugs, even when improved, are considered part of the original patent. For instance, if a local manufacturer has a license over the original patent, they do not need to get a secondary license for the improved drug, new form, formulation, or new use, hence ensuring access to the latest innovative drugs at a lesser cost. This reduces the danger of second-use licensing and patenting. Apart from restricting what can be patented, TRIPS flexibilities allow nations to exploit patented and patentable innovations in the medical field through the use of the compulsory licence, parallel importation, or government use. These flexibilities have been very crucial in lease develop and developing countries getting access to medical technology and drugs which they would not have had access to. The success of access can be seen in the response to HIV/AIDS. Success was seen when countries took advantage of the flexibilities, such as local manufacturing of generic medicine after government licensing, and parallel importation. This milestone was made possible by the Doha Declaration, which, among other issues, clarified that the TRIPS flexibilities can be employed to ameliorate the negative impacts of patents on medicine access. Compulsory licensing allows the local manufacturers to access the technology and produce drugs locally, making them cheaper than the original drugs. Also, this saves the costs of drugs as there are no importation charges and delays. For countries which cannot manufacture drugs, there is now a legal framework which allows the country to import from a third country. The use of parallel importation is crucial in allowing cheaper and more affordable drugs by allowing a country to import generic versions of a patented drug from a country where it has been launched on license at a lower price than the local market or elsewhere. This allows the prices to be reduced and further allows many people to afford them. This is provided under the Doha Declaration. This ensures that affordable drugs can be procured by countries which are small and lack the necessary capital and infrastructure to manufacture the drugs. For instance, country A can import compulsorily licensed HIV/AIDS drugs from country B; the reasoning can be that it would be cheaper, especially if they are neighbours, like in sub-Saharan Africa. This would reduce the cost of production and also costs. Even though the implementation of paragraph 6 of the Doha declaration is problematic and marred with many challenges, such as the exporting country changing its national laws, it is a big step towards ensuring that developing and least developed countries can af...