Compulsory licensing of patented pharmaceuticals in the developing world : a legitimate or illegitimate way to enhance the access to medicines?

• Main Author: Le, Vu Van
• Other Authors: Hyland, Mark ; Shi, Wei
• Published: Bangor University 2018
• Online Access: https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.767439

The objective of this thesis is to examine the implementation by three carefully selected developing countries of one of the most significant and controversial TRIPS flexibilities - compulsory licensing - so as to meet their differing pharmaceutical needs. This objective will be achieved by adopting a comparative approach between international (TRIPS) and domestic (India, Brazil and Thailand) patent laws, and by conducting a cross-national study of these patent regimes. This thesis critically evaluates the compulsory licensing mechanism of the aforementioned countries, each considered to be an emerging economy, capable of challenging the dominance of OECD nations. The findings suggest that each country's application of compulsory licensing is closely linked to two factors: how it has implemented TRIPS and, its pharmaceutical manufacturing capacity. Where a state capitalises on TRIPS flexibilities and has a well-developed manufacturing capacity, it is unlikely to use compulsory licensing (e.g. India). In contrast, where TRIPS flexibilities are underutilised combined with a low industrial development, then the grant of compulsory licences is highly likely (e.g. Brazil and Thailand). On the one hand, all the compulsory licence grants, to some extent, produced significant effects on society. In the short-term run, these licences eroded the monopoly of patent holding companies, driving down the price of medicine, thereby increasing the number of patients in treatment. Furthermore, as regards India and Brazil, mandatory licensing also resulted in price deductions for other medicines which were not subject to the compulsory licence. Somewhat surprisingly, in all three country case studies, the generics were not made at the cheapest price, compared with the substitutes available on the market, an important consideration for parties seeking a compulsory licence. This work concludes that each country case study has developed its own distinctive regime. The fact that India's compulsory licences were initiated by private companies signifies that this legal tool has mainly served its thriving pharmaceutical industry. An absence of governmental participation in India has caused the country's mandatory licensing to be seen as purely a legal issue. Meanwhile, Brazil and Thailand applied government use licences to respond to their national health needs. This gave a strong political hue to the compulsory licensing regimes in those countries, particularly Thailand's. While Brazil efficiently employed these licences as 14 strategic threats in return for price cuts offered by patent holding companies, the seven licences issued by Thailand's post-coup government are considered extraordinary. It was viewed that an unlawful government was trying to curry favour with the Thai people. The legitimacy of the Thai licences was placed in significant doubt. Given each country's unique characteristics, it is clear that compulsory licensing should not be regarded as a 'one-size-fits-all' solution to combat all healthcare issues in less-developed nations. In addition, this work seeks to achieve a secondary objective of critically evaluating the position of the following multilateral organisations on the issue of compulsory licensing of pharmaceutical products: the EU, WIPO, the WHO, and health-related NGOs. While the EU has built an image as a quiet and tactful player, WIPO displays subtle opposition to compulsory licensing. The WHO attempts to maintain a neutral stance in the ongoing deliberations while the NGOs want to dismantle any barriers to the access to medicines, created by TRIPS.