...there is a total lack of transparency on the prices paid by governments for medicines. There is no public access or transparency regarding the clinical trials which test the efficacy and security of our medicines. We do not know how much has been invested in research nor do we have mechanisms to trace costs of production. A legislative effort should be undertaken to achieve transparency in industry's investments in R&D as a process which would benefit both corporate public image and patients' access to medicines....
Life Saving Medicines and Patent Slaving Monopolies
by
Beatriz Becerra Basterrechea Member European Parliament
Jacob Hammerstein Casanova Trainee to Beatriz Becerra Basterrechea
Javier Aparicio Rubio Accredited assistant
Since I took office last summer, I have been involved in a wide range of issues related to my parliamentary activities; issues which have led to a full engagement of my office team and their commitment. It has been a path of discovery and idea-gathering leading us deeper into full involvement. Amongst these, I have aimed my parliamentary work at getting involved in issues related to access to medicines, and specifically in drawing attention towards the ongoing struggle for universal access to treatment for Hepatitis C patients. Altogether, it is essential to highlight the need of looking at the full picture and broadening our focus on prospective alternatives to leave fatal resignation on such a crucial issue behind.
In this field, we have openly focused our discourse on the broader issues underlying access. I decided, together with my team, to outline a strategic working line focused on the unveiling of causes underlying lack of access and addressing structural issues with a pragmatic approach as a must to overcome unjust scenarios which otherwise can only be tackled circumstantially. One often gets the impression that industry’s marketing departments are delighted with public demands calling for health systems to pay exorbitant prices for their patented medicines. There is not a single multi-million advertising campaign which could have such a boosting effect on a company’s sales. What ball game are we playing? It should definitely be the one for common goods and public health.
In the case of Hepatitis C, immediate instruments exist to make a treatment which is believed to be very efficient -and interferon free, implying bigger patient eligibility- accessible and affordable for the vast majority of patients. A very feasible step, which just requires minimal coordination amongst States would be to prepare a pooled procurement strategy. Obviously, neither the EU Commission, under its internal market competences, nor member States, have shown a true political will to promote such strategy.
International treaties also offer concrete instruments which could be easily put in use to favour cheap and affordable Hep C second generation direct acting antivirals (DAAs). World Trade Organisation’s TRIPS, and its Doha Declaration interpretation offer more than enough flexibilities. Compulsory Licenses are a possible option for cases of public health emergencies. Such is the case in Spain, with an estimated 800.000 people infected with Hepatitis C. The lack of an active diagnosis strategy, and an exorbitant price of approximately 25.000 euros per treatment just for Sofosbuvir, has conditioned a national plan which has only been able to commit to the treatment of 5.000 patients with new DAAs. Under these circumstances, the issuing of a Compulsory License would be something to be considered. The EU Commission, in its 2010/03/31 Communication to the Council, Parliament, Economic and Social Committe and Committe of Regions on the EU’s Role in Global Health explicitly states: “On trade, the EU should work to ensure more effective use of TRIPS provisions to increase affordability and access to essential medicines”. Not only that, the possibility of issuing a Compulsory License also represents an added value to State´s bargaining and negotiation power with pharma companies for cheaper and affordable prices.
In India, a Patent Opposition to Gilead’s Sovaldi (commercial name for Sofosbuvir) has prospered under the premises of lack of novelty and innovation features in its molecular compound. Such a patent opposition is going to allow a treatment which was known in the US as the “$1000 dollar pill” to be produced and sold generically in India at around $100 for the full three month treatment.
This fact highlights another inexplicable situation. We, the public, as tax payers, have been turned into hostages of pharma research by becoming high risk venture capitalists. Academic research, financed with public funds, is then picked up by private corporations which take advantage of these lines of research to develop their molecular compounds which are then patented and resold to the public for exorbitant prices. How does public investment benefit public good in such cases? What mechanisms do we have as citizens to trace our investments in the development of patented drugs? The answer is unfortunately none. This is a lose-lose situation for the public.
The case of Hepatitis C drug Sofosbuvir could be related to such a phenomenon: Pharmasset Inc. took advantage of British academic research undergone at a public university to develop Sofosbuvir. This lab was later bought by Gilead for $11.000 million. It is remarkable that just after the first six months at market (and it still wasn’t at sale in most of the world’s territory), Gilead’s Sovaldi had made up for 50% of what they invested in the purchase of Pharmasset. It is not surprising at all that in the case of Sofosbuvir, Gilead didn´t even undergo research.
Everybody agrees on pharma’s rights to profits, but the limits to pharma’s profits should be clearly outlined and defined by a few basic principles.
One of pharma’s main arguments to justify off limits return on investment and profits is the risk involved in their research. We clearly reckon pharma´s risk taking position when undertaking research. Nevertheless, we encourage pharma companies to disclose clear figures on what percentage of their income is destined to R&D, as to other spheres of business, for example marketing. Once again we are confronted with a total lack of transparency. What´s the real average cost of developing a new drug?
Furthermore, we could draw a parallelism between the fight which underwent in the 90s and early 2000s for universal access to HIV Retro-Virals, with the ongoing struggle for universal access to Hepatitis C second generation DAAs. While in the past it has been proven, as with HIV treatments, that patent monopoly based biomedical systems are totally inefficient to guarantee fair access and affordability to medical treatment, history is unfortunately repeating itself in the case of Hepatitis C medicines.
This situation stresses the need of addressing the underlying structural factors which have brought us to the current situation. It all starts with a biomedical R&D model oriented at strengthening intellectual property monopolies and reaffirming exacerbated corporate profits over public interest and health. A cultural myth has prevailed which legitimises patent monopolies as the best incentive for R&D and drug development. This statement is deeply confusing and far from reality. The current system of biomedical R&D based on patent monopolies is really a handicap for research. Given the absolute lack of transparency in clinical trials, lines of research are often duplicated. Furthermore, pharma companies are more often focused on patent hunting and “evergreening” (applying minor changes in terms of innovation) their treatments for patent renewals than offering real added value drugs with proven therapeutic advantages. The current biomedical R&D system has proven, far from presenting incentives for research, to materialise in patent monopolies; compartmentalised and overlapping groups of multiple patents over single goods or technologies (thickets), lack of knowledge transfer and an obscure manipulation of the scientific method, all of which hinders innovation.
Regarding monopolies, other fundamental spheres of our economic activities have been regulated. Some clear examples of how regulation has incentivised competition and accessibility in terms of prices is the telecommunications sector. In this also strategic sector, efforts have been made to cap prices (see EU regulation on roaming), or to delink the pipeline process, meaning that one same enterprise cannot control the entire process: a single telecommunications company is no longer allowed to be the builder of the infrastructure, owner of cables and towers, supplier, commercialise, advertise… all together.
There are specific and pragmatic alternatives to the current model. De-linkage in biomedical R&D would imply separating research and development costs from the final price of the medicine. This could be achieved through several instruments such as price incentives for open source medical research, patent pools, socially responsible licences, imposing strict conditions on the use and exploitation of public research by private corporations to assure a return for public interest, open access to scientific research developed and financed with public funds and transparency on trial results.
The European Council has repeatedly encouraged the EU and Member States to take steps in the direction of disassociating costs of R&D with the final prices of drugs, a clear example of which are the Council Conclusions on the EU Role in Global Health May/2010.
Furthermore, there is a total lack of transparency on the prices paid by governments for medicines. There is no public access or transparency regarding the clinical trials which test the efficacy and security of our medicines. We do not know how much has been invested in research nor do we have mechanisms to trace costs of production. A legislative effort should be undertaken to achieve transparency in industry’s investments in R&D as a process which would benefit both corporate public image and patients’ access to medicines.
Given the nature of our parliamentary work as elected representatives serving public good, and furthermore, taking into account article 168 of the Treaty on the Functioning of the European Union (TFEU) stating “A high level of human health protection shall be insured in the definition and implementation of all Union policies and activities”, which we all supposedly commit to serve as members of this parliament, my demands on access to essential and lifesaving medicines could not differ from those I’ve exposed.