An Exceptional International Intellectual Property Law Solution for COVID-19
-There is no doubt about the role international law can play in order to face current COVID-19 pandemic. The answer is crystal clear: reform to current International Intellectual Property Law regime for more innovation and access to medicines, flexibilities to the patent system that will allow more innovation, and effective co-operation/coordination in the scientific world. This could be a real and pragmatical contribution facing this unprecedented crisis that highlights the necessity of coherence at the international institutional and national level, stronger international co-operation (specifically between World Health Organization (WHO, WIPO, WTO, UN, G20, and the European Union as the top net exporter of pharmaceuticals ) and real solidarity to protect the most vulnerable individuals affected by different measures that restrict individual freedoms worldwide.
-This new global pandemic of international scope makes us think of the prevailing need to declare medicines as global public goods. It is time to reform the international intellectual property system, especially the patent regime, as we need imminent research and development(R&D). Most of the pharmaceutical discoveries and advances have been made with state investment, regardless this, several pharmaceutical multinationals in recent weeks have oriented their strategy towards filing new patents, test data and utility models aimed more at increasing royalties than at saving us from this unprecedented COVID-19. In other words, many patented inventions are based on publicly subsidized research in public institutions. Therefore, it is the global public that pays taxes that finance some research. Consumers have to pay higher prices for patented products and in the process there is a loss of intellectual commons. That is why it is imperative to de-link R&D from the final cost pay by consumers, especially in developing countries.
-A legal system that allows the monopoly of transnational corporations brings more inequality and less growth, and the lack of leadership and cooperation of the international organizations in charge of taking measures against the pandemic is evident. But not all is lost, the President of Costa Rica sent a letter to the WHO Director requesting that access and use of intellectual property that protects technologies to detect, prevent, control and treat the pandemic by COVID-19 be allowed. This "pool" of technologies would include patents, copyrights, test data, research for diagnosis, treatment, medicines and vaccines, among others. This proposal has been endorsed by directors of global pharmaceutical companies as well, different international public health organizations and by the director of the WHO himself. -Let's hope that this opportunity for technology transfer, financing and global cooperation is not wasted and is supported by the governments of the world. Colombia must lead by following up on this issue since, as I will explain later, the price control strategy or the use of compulsory licenses in the framework of a State of emergency are insufficient measures that require other urgent emergency actions. Before presenting the recommended strategy for Colombia, let's review quickly some measures that have been taken by different countries so far regarding paten law regulatory changes:
- Chile and Israel have requested the implementation of the compulsory licensing mechanism that would allow the development locally of low-cost medicines, better known as generics, upon payment of royalties to the holders of said rights. Ecuador has done the same, it has also requested access to test data and non-commercial public use. Canada and Germany seek by law to nullify patents. The ministers of science and technology of: Spain, Australia, Brazil, Canada, France, Germany, India, Italy, Japan, New Zealand, South Korea, Portugal, Singapore and the United Kingdom have considered “the possibility of excepting global patent regulation, with the aim of speeding up technology licensing and transfer processes, so that we can manufacture certain products around the world quickly”. - The true wealth of countries should now be measured in their ability to respond effectively to the pandemic and to safeguard the life and health of all inhabitants without exception or exclusion. All lives have the same value. Now, let’s highlight some recent proposals on what should be the roadmap of countries like Colombia facing this challenge of enormous ethical, legal and existential dimensions. Costa Rica's proposal should be the flag of the entire region and of the world as it favours all interested countries. The use of compulsory licenses has been tried in the past in Colombia, without success for various reasons. Recall the case of (lopinavir / ritonavir) to treat HIV / AIDS ended in price regulation. Remdesivir is also being studied for the COVID-19 it is patented and there are other patents in the process of study. The same must be said regarding Hepatitis C drugs and more recently, the debate related to IMATINIB also ended in price regulation and not in compulsory licenses. - Compulsory licenses have been given in many countries like Thailand, Brazil, Mozambique, Zimbabwe, Zambia, Rwanda, Malaysia, Indonesia and recently India. Also, developed countries in Europe and the USA have used compulsory licenses before. According to estimates from the WHO, nearly 6.5 million people in low and middle income countries are in urgent need of ARV treatment. However, due primarily to patent protection and high prices charged by drug companies, only 1.3 million people actually receive treatment. Nearly 80% of the 3 million people who die each year from AIDS have no access to the available medicines. Brazil had to comply with the TRIPS Agreement in order to protect foreign technology and recognize minimum standards for the protection of pharmaceuticals and patents and modify its domestic legislation even though the costs were too high for the Brazilian health budget.
-There are many advantages of compulsory licenses for developing countries. The main benefit for society as a whole is making the drug product available at a reasonable cost and as a consequence, saving more lives as developing countries are able to access medicines that have become more affordable. At the same time, knowledge cartels and Transnational Interest Blocks are challenged as governments may control dominant positions of firms. Also, voluntary licensing of patents can help create new solutions and promote access to medicines. Some have pledge to make intellectual property available free of charge for use in ending the COVID-19 pandemic and minimizing the impact of the disease.
What is the overarching societal function of the contemporary Intellectual Property regime in the context of COVID-19 and to what extent is that function attainable given the existing design of International Patent rules and associated domestic rules regarding pharmaceutical patents in developing countries?
- There are different proposals in Colombia aimed at directing the policy of the national government to suspend the exclusive effects of patents to respond to this pandemic of international scope. That is, the temporary suspension of intellectual property rights (monopolies) granted by patents, test data and utility models without this implying any infringement since a subsequent mechanism for the payment of royalties can be established. Also, it has been proposed the suspension of all patent procedures and other forms of intellectual property and patent procedures, utility models and protection of test data on technologies or information that could be useful to face the pandemic and request companies that have relevant industrial secrets for the development of mechanical ventilators, for example, to disclose such information of public interest. And guarantee the supply of medicines that are necessary to produce in Colombia for all citizens and residents in the national territory.
-The global south should use existent TRIPS flexibilities more aggressively combined with competition policy and better international coordination to face and solve this pandemic. There is a need to put life and human rights at the centre of the International institutional and regulatory system and political cooperation is required now more than ever. Subscribing to the “medicines patent pool of technologies” proposed by Costa Rica with WHO coordination is the key since representatives from developer companies have welcomed this solution so far. Patent pools reduce significantly the cost of research and it makes licenses available in a non-discriminatory and non-exclusive basis to facilitate the production of an affordable solution vaccine. Other international organization from the global south have proposed recently to make use of Article 73(b) of the TRIPS Agreement to suspend the enforcement of any intellectual property right including patents, designs and trade secret on the grounds of the security exception.
- Finally, there is a need to rewrite and reform the basic premises of present Intellectual Property Law system one that constitutes a main legal tool of control since COVID-19 is a pandemic of international scope that is currently challenging mainstream views about the world economy, knowledge monopolies and market oriented incentives to innovate. The existent international and national architecture of Intellectual Property law confers privileges to foreign Transitional Interest Blocks in order to profit from patents, trademarks, copyrights and so on for longer periods of time, this legal enclave, diminishes the possibility of developing a vaccine and to distribute it fast to all the countries currently affected by the pandemic. However, the creative elements of a new global system are emerging now, one characterized by coordination, shared innovation and prompt access for all the countries of the worlds since the Sustainable Development Goals shared mandate to work for good health and well-being for all.