We spoke with Ancel-la Santos, the Policy Advisor of Health Action International, an NGO working on the European level to improve the affordability and rational use of drugs. Ancel-la coordinates political advocacy actions and the follow-up on the European Union’s pharmaceutical policies. We talked with her a few weeks ago during the meeting “Access to Medicines: Global Inequity in the Fulfilment of the Right to Health,” organized by Farmamundi, and this is what she told us.
– How would you describe the European panorama of drug access?
I believe the financial crisis marks the before and after. Budgetary limitations and the elevated prices of new drugs made it difficult for the States to cover them. This context led to greater awareness of the growing problem with high drug prices, such as with oncological drugs. This problematic situation has given the civil society movement that works for medicine access in Europe a strong boost.
In any case, in the end, the crisis has revealed the existing problems that were being overlooked because public budgets were not analyzed meticulously. Unfortunately, we are facing a systematic issue and are in urgent need of modifications to the model of development, approval and commercialization of medicines.
– There is also a growing debate on intellectual property.
The intellectual property model currently in use is increasingly questioned. In Europe, there is more open talk about the possibility of using flexibilities, such as compulsory licensing, which have been employed by less developed countries to ensure access to medicines. We found an example of this in the 2017 European Parliamentary reporton the options for improving access to medicines and in the declarations made by some national governments.
– What can we expect from this debate? Which existing instruments may lead significant advances?
Efforts should be geared towards alternative R&D models that do not revolve around exclusive intellectual property rights. Instruments, like the European program for R&D project financing (Horizon 2020), could help produce advancements in this regard. But for this it is necessary that these programs are always designed by placing public interest criteria above any other criterion.
In the intellectual property field, in 2016, the State members asked the European Commission to conduct a study to assess the impact these incentives have on drug affordability and availability. Initiatives like these open the door for debates on these topics, but we need to go further and take concrete action. Given the growing criticism of the industry’s abuse of incentives for orphan drugs, it would be good for the Commission to take specific steps to correct the situation and opt for an alternative rare disease R&D model. These measures are essential to ensure the affordability of the drugs pharmaceutical companies charge excessively high prices.
– And what role does the industry play?
The pharmaceutical industry defends private interests that often conflict with the defense of the common good. That is why we cannot depend on the industry’s self-regulation. We need to demand increased and improved regulation from the Government and the placement of the common good before private interests. The pharmaceutical sector must be heavily regulated as it has implications for the right to health, a fundamental right, of all individuals.
– What presence does the industry have on the decision-making bodies in Europe?
The industry has a strong presence in public policy debates and dedicates many resources to lobbying and influencing decisions of public institutions. Their resources cannot be compared to those of civil society. In 2015, Corporate Europe Observatory (CEO) published a study on the lobbying activities carried out by pharmaceutical companies against EU institutions and the enormous amount of resources they are capable of mobilizing. (According to this report, the industry devotes 15 times more resources to lobbying than civil society actors working in public health or access to medications. It is available here.)
In 2012, Health Action International and CEO published a similar reportthat also highlights the immense disparity between the influx of industrial lobbying with the EU and that of the public interest groups in the field of health.
– Your organization is highly critical of the role of the European Medicine Agency (EMA) and its relationship with the pharmaceutical industry.
On a regulatory level, the problem is that there is significant capture risk. It often seems that the EMA treats the industry more as a partner than an entity that needs to be regulated. For example, when the EMA confidentially advises a company on the development plans of a drug and then, upon payment, evaluates the same medicine it compromises its independence and the healthy distance that must exist between the regulatory body and the regulated one. This is especially true if the same experts involved in the scientific advisory processes evaluate those same drugs.
It should be remembered that the EMA is financed more than 80% by the pharmaceutical industry. Companies pay fees when they apply for market authorization, when they ask for scientific advice, etc. This can lead to a customer relationship: more services offered, more fees and more resources. Other funding formulas should be developed and various measures to ensure the regulator’s independence should be implemented. In terms of scientific advice, the publication of scientific guidelines should be prioritized and personalized advice should become an exceptional, publicly-funded and transparent activity. The transparency issue is being assessed by the European Ombudsman in the context of an investigation on how the EMA manages its ‘pre-authorization’ services. It will be interesting to read the conclusions and recommendations of this research.
– Patients are also an essential part. What capacity do they have to influence the decisions that are made in Europe?
The EMA has a working group of patient and consumer organizations, of which HAI is a member. It is important to include both in the regulatory discussions so that the decisions have more legitimacy. It is also vital to ensure representation when patients are consulted in the drug evaluation process, as patient groups are not homogenous. The fact that many of the patient organizations are financed by the industry is particularly concerning. One has to ask what is the industry’s motive in funding patient groups engaged in activities of political advocacy and whom participate in the regulatory process.
– From your point of view, what are the most noticeable advances in recent years?
One of the most important advancements on the European level is in terms of the transparency of clinical trial results. In recent years there has been ample social mobilization among groups of patients, consumers, medical professionals and scholars to improve public access to data on the safety and efficiency of medicines. This mobilization has been key for the new European regulations on clinical trials approved in 2014 to include the obligation to publicizing clinical study reports that companies give to regulatory agencies. Unfortunately, the enactment of the regulation has been delayed, but will be in effect next year.
It should be noted that the EMA has also made significant progress on transparency and that since October 2016 it has published these reports. Although there is a long way to go, these initiatives represent an imperative qualitative leap. From the civil society sector we will be closely monitoring it to make sure they are properly implemented, since according to a recent study the current less ambitious regulations on transparency, are not largely met.
Another advancement is the major debate with the problem of elevated drug prices, the inefficiency of the current model of biomedical research and the abuse of intellectual property rights.
– What action capacity do governments have in terms of such a global issue?
In R&D, for example, the Governments are the principal financers of fundamental research and they play an important role in the financing of biomedical research. They have the power to implement funding programs for R&D in line public interests, that guarantee ample access to scientific data and the affordability of the drugs that benefit from public funds for their development. The latter can be achieved, for example, by conditioning public funding on non-exclusive use of intellectual property rights. There is still a lack of political will to take real steps towards a new R&D model, but this would certainly be easier if done in a coordinated and joint manner both regionally and globally.
To set the political agenda, it is essential to mobilize citizens through public campaigns that report on the inefficiencies of the current system and the initiatives that can help improve access to medicines. We must also continue to stress the need of using the flexibilities offered by the TRIPs agreement and reform intellectual property regulations so they do not obstruct the right to health. Another interesting mechanism at Governments’ disposition is price negotiation and joint purchase of medicines. Recently, Belgium and the Netherlands reached a joint agreement on the price of Spinraza with the company that commercializes it.
In reality the issue with elevated drug prices is a common challenge that needs a global response.
