Compulsory licensing was a flexibility often invoked by countries, which in some cases was not implemented, hence the conclusion that it may have served to encourage pharmaceutical companies to enter into voluntary licensing agreements. 7. Moon S. Strong ideas for global access to medicines. N Engl J Med (2010) 376: 505-7. doi:10.1056/NEJMp1613861 Anderson T. The tide is turning for the manufacture of medicines in Africa. Lancet. 2010;375:1597–8 doi.org/10.1016/S0140-6736 (10)60687-3 pmid: 20458781. (accessed November 25, 2020). 28. Compulsory licences are important instruments for the protection of public health. Of course, compulsory licensing alone will not solve all public health problems, as other structural factors can also contribute to restricting access to medicines.
However, the TRIPS Council is invited to examine the extent to which intellectual property rights in certain patents may constitute an obstacle to access to medicines. Members should consider that the TRIPS Agreement does not in any way impede the protection of public health and should therefore provide the greatest flexibility for the use of compulsory licenses. The TRIPS Agreement has led to very significant changes in international standards on intellectual property rights. Because of its profound implications, it is one of the most controversial components of the WTO system. At the initiative of developing countries, concerns about the impact of the TRIPS Agreement on public health were reflected in the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001. The declaration was followed in 2003 by a Council Decision on TRIPS on the implementation of paragraph 6. In this article, the author notes that the supposed implementation of paragraph 6 is unlikely to exert strong pressure on patent holders to lower their prices or negotiate voluntary licenses. The author points out that controversies are likely to continue, especially as developed countries seek TRIPS protection more by interpreting or negotiating bilateral and regional agreements, and as patents on insignificant developments are granted and used to block or delay generic competition. The statement also notes that members recognize that the system “should be used in good faith to protect public health and, without prejudice to paragraph 6 of the Decision, should not be an instrument for the pursuit of industrial or trade policy objectives”. The only reasonable interpretation of this statement is that the importing country should use the system for public health reasons, but this certainly does not preclude the supply of the necessary drugs that pursue a profit objective by commercial enterprises. Without the ability to make a profit, potential suppliers will not have the incentive to make the investments (including covering legal fees) necessary to meet the requirements of countries without production capacity. All WTO Member States may import under this Decision, but 23 industrialized countries have voluntarily announced that they will not use the system for imports: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, the United Kingdom and the United Kingdom.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and the same concerns expressed during the negotiations, such as high drug prices, market exclusivity and late entry into the generic market, have now been 25 years old, remain relevant, as recently highlighted by the Ebola and COVID-19 pandemics. The mandate of the World Health Organization (WHO) to work at the interface between intellectual property, innovation and access to medicines has been continuously strengthened and expanded to help countries implement the flexibilities of the TRIPS Agreement in cooperation with stakeholders. This study analyses the role of IP in access to medicines in the African region. Liang, B.A. Parallel trade in medicines: infection of the counterfeit element in public health. 31 N.C.J. Int`l L & Com Reg 847 (2005) available at: scholarship.law.unc.edu/ncilj/vol31/iss4/2 (accessed 25 November 2020) WHO has the opportunity to work with ARIPO and OAPI to help countries review their legislation to better meet public health needs. In fact, the creation of separate categories of intellectual property protection for different classes of medicines allows for tailor-made protection that can both foster innovation and defend the fundamental human rights of those who need important medicines.
Parallel imports allow a developing country to take advantage of current practice according to drug prices in different countries. For example, if a package of nevirapine, a patented medicine, is sold for $250.00 in France and for $275.00 in South Africa, a South African company (or the government itself) can import the drug from France and sell it at a lower price without the permission of the South African patent holder. Parallel imports allow countries to purchase patented medicines at the lowest price in the world. The right to parallel imports under the TRIPS Agreement is based on a fundamental legal principle known as the `exhaustion` of intellectual property rights, which defines the date on which a patent holder no longer has exclusive rights in connection with the resale of his product (5). Article 6 of the Agreement stipulates that Member States may decide independently when the exclusive resale rights of patent holders are terminated, but exhaustion issues cannot form the basis of a dispute to be brought before the WTO for resolution. In fact, Article 6 of the TRIPS Agreement allows member countries to import parallel imports. We analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and the African Intellectual Property Organization (OAPI) to provide an analysis of the status of patent activity and trends. We are also reviewing legislation to assess how the flexibility of the TRIPS Agreement is being implemented in countries.
This study considers flexibilities as understood in the context of the TRIPS Agreement, its Protocol of Amendment and the Doha Declaration to the TRIPS Agreement on Public Health (Doha Declaration). Footnote 20 We define the flexibilities of the TRIPS Agreement through the prism of Articles 1.1Footnote 21 and 8.1 and Footnote 22, which give countries policy space to implement the TRIPS Agreement in a manner appropriate and appropriate to their context, as different options that take into account national interests and can be transposed into national law. The biggest problem with compulsory licensing, as described in the TRIPS Agreement and its amendment, is that they are not drafted as a minimum standard that countries must apply in their national legislation to be TRIPS compliant. Rather, it is an option available to Member States for transposition into their national legislation. As a result, only five jurisdictions that have the pharmaceutical capacity to be exporting countries with compulsory licences have actually made progress in transposing these measures into their national legislation (18). If the Doha Declaration is considered to be an accurate reflection of the feelings of nations, provisions on compulsory licensing should be included in the TRIPS Agreement as an obligation for Member States. Where separate classes of medicinal products are created, as indicated in the first Recommendation, at least provisions on compulsory licences for essential medicinal products should be required to comply with TRIPS. – From my research, I have come to the conclusion that there are ways that still need to be addressed to reconcile the interests of commercial pharmaceutical companies with the human rights of patients in developing countries.
23. Diependaele L, Cockbain J, Sterckx S. Raising barriers to access to medicines in developing countries – the relentless push for data exclusives. Dev World Bioeth (2017) 17:11-21 doi:10.1111/enwb.12105 The WHO African Region is characterized by what could be described as a collage of Member States in terms of intellectual property regulation and governance. . . .