January 16, 2016
(author: Laureen Missaire) – The Transatlantic Trade and Investment Partnership, a controversial international trade agreement, is being negotiated at this moment and will have some major impact on society and particularly on public health. The negotiations started in July 2013 and the most recent 11th round of negotiations have taken place on 19-23 October 2015 in Miami (USA). In her bachelor thesis, Laureen Missaire discusses, what would be the specific impact of TTIP on access to medicines in the European Union.
(Cover photo © Caroline Pultz)
Background and ‘access to medicines’ research subject
There is a clear link between TTIP and access to medicines. Medicines are an integral part of aiding people to reach high standards of health. Therefore, access to medicines is a highly relevant subject due to health being a precondition for “good” economy and growth. The research investigates the impact of the Transatlantic Trade and Investment Partnership on access to medicines in the European Union, and was performed in the context of my bachelor thesis in European Public Health at the university of Maastricht.
Setting the scene: What is TTIP
TTIP, a controversial bilateral free trade agreement, is being negotiated at the moment between European Union and the United States of America. It is constituted of three important parts: market access, regulatory cooperation and coherence and rules. The structure of TTIP is displayed in Figure 1, the TTIP concept map. Due to the large scope covered by the agreement – including regulatory cooperation on the field of pharmaceuticals, the research only focuses only on intellectual property rights with regards to access to medicines in the EU.
What ties together TTIP and access to medicines?
Access to medicine is a truly important public health issue and imperative to be tackled, as medicines are an integral part of enabling people to reach the highest attainable standard of health and for their right to health. Furthermore, there are huge inequalities with regards to access to medicines within and between the European Member States. For example, a wealthy family has an easier access to medicines but also an easier access to screening when compared to a low-income family. Shortages in medicines can occur at the local, national, European and international levels. Finally, there are several causes of threats to access to medicines; for instance, long patents and monopolies, pricing techniques, lack of innovation (especially for rare diseases), supply-chain issues but also the patient setting (e.g. opening hours and the localisation of the pharmacy). The pricing and procurement practices, as well as reimbursement rules of the European Member States also influence access to medicines within the European Union. Figure 2 illustrates access to medicines as being a multifaceted issue.
Intellectual property and TTIP
Access to medicine is directly linked to intellectual property rights. This means that the pharmaceutical industry has a monopoly on a certain type of medicine (or its molecule) for a certain period of time, usually 12 years in the EU. Due to the patents, the industry has the opportunity to reimburse the research and development costs and makes a certain amount of profit as well as further researches. The basis of the existing regulation is the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This agreement focuses on intellectual property rights and is administered by the World Trade Organization (WTO).
Research methodology and data collection
The main theoretical framework used in the research was based on the idea of a political discourse analysis which takes into account the texts and talks of professional politicians or political institutions (Van Dijk, 1997). The timeframe for the research and therefore the analysis of the political discourse took place from February 2015 until May 2015.
The research is qualitative and explanatory. It is qualitative because it investigates the views of different important stakeholders in the field of medicines and trade, and analyses the available literature concerning the issue. A balance between industries (e.g. European Generic Medicines Association (EGA), European Federation of Pharmaceutical Industries and Associations (EFPIA)), and public interest groups (e.g. Pharmaceutical group of the EU (PGEU), Health Action International (HAI)), academia (e.g. Friends of Europe, London Schools of Economics (LSE)) has been attempted to be respected as much as possible in order to avoid bias. In addition, the research is explanatory because it explores a phenomenon about which little is known at this point of time (Paulus & Van Raak, 2005).
The outcome of the analysis
Many questions aroused while performing the research with the focus on political discourse. For instance, there is a dilemma into the negotiations; the EU has to make the decisions of what to fight for and what to drop out. The question is now, what is the European Union ready to let go?
In addition to that, the controversy of the debate made it difficult to access information. It also clearly shows the conflict of interest between the U.S. and the EU and even between EU stakeholders. Which is in this case between the pharmaceutical industries and the public interest groups.
Furthermore, the lack of transparency of the negotiations and the fact that some stakeholders felt that their voice was not heard made me question how to bring trust back into the process.
Conclusions and recommendations
In the case of intellectual property, there is as well a certain level of controversy. For instance, with the TTIP, there is a risk that the fragile balance between companies’ profits and access to medicines could be affected. Public interest groups have been showing their concerns on this issue. The European Commission reassures that nothing that could upset this balance is going to be negotiated. Intellectual property is a sensitive concern and the EU has tried to address this concern but is it sufficient to make sure citizens will still have access to the medicines their need?
Research performed by Laureen Missaire, graduated in European Public Health at Maastricht University (Netherlands). For questions or more information contact at firstname.lastname@example.org
Note: The researcher was an intern at the European Public Health Alliance (EPHA) for the time of the study.
Paulus, A., & Van Raak, A. (2005, 13-October). Designing and executing health care research. Maastricht, Netherlands: Maastricht University.
Van Dijk, T. A. (1997). What is Political Discourse Analysis? The Netherlands: Dept. of Generary Literary Studies Universiteit van Amsterdam.
Bachelor Thesis: Who will swallow the hard pill? TTIP and Access to medicines in the European Union (pdf). [embeddoc url=”http://zmk.blogactiv.eu/files/2016/01/Thesis-Laureen-Missaire.pdf” download=”all”]Zoltán Massay-Kosubek