The Cheaper Access to Medicine: A Distant Dream Amid TRIPS?
The IP was never an important part of any international agreement even after the enforcement of GATT. Even in various bilateral and multilateral treaty agreements, IP was never a subject for negotiations. The greater reliance on the contribution of technology and international trade moving at a faster pace have made IP, the central point of all the agreements, be it bilateral or multilateral after the 1970s and 80s. This era was greatly influenced by the developed nations mainly Europe and the US. This is a reason why we see debates with regards to the provisions of TRIPS being subjected to developed nations and not for the developing nations. This has always been the subject matter of discussions around the world with regards to less compliance of TRIPS for developing nations. Discussing some of the aspects of TRIPS that primarily limits the developing nations to ponder upon their IP rights will be imperative understand.
Every country has its own need for healthcare and welfare facilities. In the prevailing situation of Covid-19, we have seen how important healthcare regulation can be for a country. What becomes more important is access to medicine. A drug manufactured enjoys the patented protection which grants it enough right to recoup the cost incurred in the manufacturing process. The patent law across the world gives exclusivity to the originator for a simple philosophical understanding to regain the cost incurred while proceeding with the research and development (R&D) for making the drug. This understanding has valid reasoning but it does not, in any case, seems to favor countries, especially developing, to ensure cheaper, affordable, and accessible medicines in the time of the pandemic. The developing countries lack sufficient resources to initiate R&D and even facing challenges like insufficient expertise and a healthcare system over the subject matter. This leads to countries importing various drugs thereby resulting inexpensive drug marketing far from making it accessible to the poor population of the country.
For example, let’s see the provision of Article 39.3 in the TRIPS which talks about the protection of undisclosed information gives us the presence of excessive protection in favor of IP holders. This generally tends to minimize the prospect of ensuring cheaper and affordable medicine in developing countries. Undoubtedly, it depends upon the states as to which area does require a robust intellectual property policy and which does not. Nevertheless, these criteria of providing a minimum standard have proved to be gone beyond the structure of minimum intellectual property protection. The usage of IP protected drugs or products by developing countries, which are manufactured by Multinational Corporations that are primarily based in developed countries, ensure a systematic payment of royalty. This means that developing countries are always in a disadvantageous position when it comes to using protected materials.
There has always been a different perspective of ideological mindset between western and eastern models. TRIPS has always been a by-product of this western-based model of profit incentivization. When we talk about the jurisprudential aspect of IP, we tend to understand the utility and incentive-based model which substantiates the model on which the western mindset is based upon. The incentive is a necessary part of the effective development of IP. But this incentivization should not defeat the right of developing countries to effectively exercise their rights to provide affordable access to medicine.
On the contrary, there comes some similar flexibility enshrined in TRIPS. Article 8 of the TRIPS in the very first move explains the principle that the member states are free to adopt measures that could protect public health and nutrition and to promote the public interest in sectors of vital importance, provided such measures are consistent with the provision of agreements. The phrase “consistent with the provision of this agreement” opens up a lot of interpretation ambit again going against the favor of developing nations. Even if a developing nation adopts measures, there are likely chances that they will face stern reaction from other countries especially developed, if it goes against any of the provision of this agreement.
On this very similar line, we find very substantial flexibility in TRIPS, i.e. of compulsory licensing. Article 31 of the TRIPS Agreement specifies the ‘Other Use without authorization of the Right Holder’. Through this article TRIPS explains the provisions which the member countries should follow while pursuing the “other use”. Compulsory licensing is the process whereby an authorization is given to the third party by the government to make, use or sell the particular product and even to use the process of the patent, without the consent of the patent owner. This might be the most powerful provision being provided which can prove to be very beneficial for developing countries. Similarly, we find an exception in Article 27.2 which gives the right to exclude patentability to protect public order and morality. Article 30 also confers the right to the member for providing exceptions to the exclusive rights conferred by a patent.
TRIPS do provide rights for the benefit of IP holders but it also leaves a lot of scopes for the developing nation to exercise various flexibilities in terms of domestic regulations and the socio-economic condition prevalent. But a close study by various academicians has shown that the developing countries seldom use these flexibilities in their domestic law. The reason might not be that easy to answer but it can be assumed that there seems to be a fear of sanction by the developed countries. This fear can be obvious because of the dependency on developed countries for various needs.
Author: Saransh Chaturvedi (an advocate) currently pursuing LLM from Rajiv Gandhi School of Intellectual Property Law (IIT Kharagpur). In case of any queries please contact/write back to us at email@example.com.