Challenges in Access to Medicine

In order to achieve equity in access to healthcare for all, a lot of factors need to be considered. For example, you need to make sure that there are enough health centers to cover the population of the country. One has to ensure a reasonable doctor-to-patient ratio. You don’t have to just look at the doctor-to-patient ratio, but also the ratio of health professionals such as Auxiliary Nurse Midwifery (ANM) and General Nursing & Midwifery (GNM) certified professionals, because they are the front-line health workers and those directly in touch with the population. Front-line health workers, in essence, are responsible for delivering all of the health schemes initiated by the Indian government. There are many other micro factors that contribute to better access to healthcare as well. In the current scenario, if you ask me about the status of healthcare in the world, I would tell you that it is dreadful; there are countries that are suffering from nationwide epidemics. One very important factor to consider while talking about access to healthcare is access to medicine as well. An estimated 30% of the world population do not have access to the medicines they need (WHO 2004). There are a number of reasons for this but the high cost of medicines is the biggest reason. Naturally the question arises: why is the cost of medicine so high? And: why are there such huge prize differences in different markets for medicines to treat the same illness? To understand this, we need to go back to the Uruguay round of negotiations in 1986 where the Trade-Related Aspects of Intellectual Property Rights agreement (TRIPS Agreement) was first proposed.

The TRIPS agreement signaled a fundamental change because it allowed countries to enforce Intellectual Property (IP) through the World Trade Organization (WTO). During this conference, 49 countries excluded pharmaceutical products from patent protection, 10 excluded pharmaceutical processes, and 22 excluded chemical processes (T’Hoen 2009). Including pharmaceutical products in the IP could have had severe consequences on access to medicine – a risk that India knew well at the time. The TRIPS agreement faced stark opposition from developing countries like India, Brazil, Argentina, Peru, Nigeria, Tanzania, and Egypt, who argued that this agreement would have severe consequences on prize of pharmaceuticals and agrochemicals. Developing countries wanted to design rules for a new international economic order, but this objective was diametrically opposed by the United States. Industries in Western member countries came together to form an international lobby group in 1986: the Intellectual Property Committee (IPC). This lobby framed U.S.-style IP and thereby sold the notion that creating monopolies was part and parcel of fair competition (T’Hoen 2009).

The pharmaceutical industry has made it harder for developing countries to have access to medicine. Claiming intellectual property rights on every medicine exponentially raises the price of medicines, but not all the countries can afford it. Pharmaceutical giants such as Abbot, Pfizer, and GlaxoSmithKline (GSK) made it increasingly difficult to manufacture generic medicines even in the early 2000s (T’Hoen 2009). In essence, high drug prices are very closely related patent law. The TRIPS agreement was adopted and implemented in 1995, where it harmonized the patent term for a minimum 20 years and made it compulsory to grant patents in all fields of technology, including food and medicine as well. India has played a major role in supplying medicines at a much cheaper rate. The developing countries which did not have pharmaceutical product patents were given a transition period to introduce the patent application form which should have come into effect latest by January 2005. This transition period was referred to as ‘mail-box’ period. The patent holder was entitled to a certain royalty but could not halt the production of the medicine. Developing countries took advantage of this transition period and started mass manufacturing of medicines for diseases with high priority. Children in developing and least developed countries are victims of HIV, Malaria and tuberculosis and the drug patenting of medicines had put a people with this diseases at high risk.

The ‘mail-box’ period was not ‘the’ solution for the future obstacles; there had to be counter negotiations to the restrictions on the TRIPS agreement, as millions of lives across the world were at stake (T’Hoen 2009). There was a huge debate on access to medicine at the 1999 WTO meeting in Seattle. Despite the U.S. administration issuing an executive order in access to HIV/AIDS medicine and medical technologies, the TRIPS agreement did not receive the necessary attention at the WTO ministerial conference in Seattle, leaving matters on the table unresolved (T’Hoen 2009). There was a massive outrage and debate on public health and the TRIPS agreement after the Seattle conference. The UN Sub-Commission for protection and promotion of human rights passed a resolution pointing out the negative consequences for human right to food and health if TRIPS were implemented in its current form (T’Hoen 2009). Pharma giants who wanted to convert TRIPS into a profit were under a lot of pressure and had lost support from their own governments, so it had become a public relations disaster for them (T’Hoen 2009). Finally the fourth ministerial conference that was held in Doha in 2001 bought access to medicine back on the negotiating table. There are a number of factors that point to the success of this negotiation: first, the developing countries came prepared as one block, so it was a clear force of collective action that made the Western countries bow down (T’Hoen 2009). Second, the U.S. and Canada found it hard to maintain their uncompromising position, owing shortage of the only known treatment for the Anthrax crisis. Third, the international outrage on access to medicines ensured that the issue would be high-profile. Thus at the conference, the Doha Declaration, as it is widely known, affirmed the sovereign right of countries to protect public health by allowing the use of compulsory licensing[1] and parallel importation[2]  (T’Hoen 2009)

To understand the kind of chaos and trade war that the TRIPS agreement ignited we can look at the legal battle between pharmaceutical giant Novartis and the Indian government over a specific drug to treat HIV/AIDS (Imatinib Mesylate) when the former was denied patent for the drug in 2006. Novartis legally challenged both, the decision to deny patent for Imatinib Mesylate and legality of a certain section of the Indian Patent’s Act (Jack 2007). They argued that the Indian Patent Act violated the Indian constitution and the TRIPS agreement (Jack 2007). Novartis’s action aroused widespread international criticism: international NGOs organized global petitions calling upon Novartis to drop the case (Jack 2007). The Novartis challenge was seen as a direct assault on TRIPS flexibilities in a situation when India had become known as the pharmacy center of the developing world (Jack 2007). In 2007, the Madras High Court ruled against Novartis and rejected all its claims.

The belief that granting temporary monopolies to inventors encourages innovation has to change. It always comes at the cost of society. The pharmaceutical industry argues that without patenting, there would be no innovation at all. When Jonas Salk, the inventor of polio vaccine was asked, who would own the patent? He replied: “The people! Could you patent the Sun?” (Lee 2013). He considered his invention a public good. If you look at the entire issue of access to medicines, you realize that it was never an issue. It became an issue because pharmaceutical companies wanted to increase profit through access to a global marketplace – however, this came at the expense of the world’s vulnerable populations, putting the lives of millions of people are risk.

Notes: 

[1] Compulsory licensing enables competent government authority to license the use of a patented invention to a third party or government agency without the consent of the patent holder against the payment of adequate remuneration.

[2] Parallel imports are cross-border trade in a patented product, without the permission of the manufacturer or publisher. Parallel import take place when there are significant prize differences for the same good in different markets.

References:

• Abbott, Frederick M., and Jerome H. Reichman. “Access to Essential Medicines: Lessons Learned since the Doha Declaration on the TRIPS Agreement and Public Health, and Policy Options for the European Union.” European Parliament, June 2007. https://www.europarl.europa.eu/RegData/etudes/etudes/join/2007/381392/EXPO-INTA_ET(2007)381392_EN.pdf.
• Angell, Marcia. “The Truth about the Drug Companies.” The New York Review of Books, 51.12 (2004). https://www.nybooks.com/articles/2004/07/15/the-truth-about-the-drug-companies.
• Banta, David. “Public Health Triumphs at WTO Conference.” Journal of American Medical Association 286.22 (2001): 2655-56. https://www.ncbi.nlm.nih.gov/pubmed/11730421.
• Jack, Andrew. “Novartis to Move Indian R&D.” Financial Times, 21 Aug. 2007. https://www.ft.com/content/b81b69c4-5007-11dc-a6b0-0000779fd2ac.
• Lee, Peter. “Patents and the University.” Duke Law Journal 63. 1 (Oct 2013): 1-87.
• T’Hoen, Ellen F.M. The Global Politics of Pharmaceutical Monopoly Power: Drug Patents, Access, Innovation and the Application of the WTO Doha Declaration on TRIPS and Public Health. Diemen (Netherlands): AMB Publishers, 2009. https://msfaccess.org/sites/default/files/MSF_assets/Access/Docs/ACCESS_book_GlobalPolitics_tHoen_ENG_2009.pdf.
• World Health Organization. “The World Medicines Situation.” WHO, 2004. https://apps.who.int/medicinedocs/pdf/s6160e/s6160e.pdf.
• World Trade Organization. “Trade-Related Aspects of Intellectual Property Rights.” WTO, 2019. https://www.wto.org/english/tratop_e/trips_e/trips_e.htm.