The problem of unaffordable medicines and the need for health-driven innovation are not on EU agenda

Due to the high cost of medicines, millions of citizens of EU member states cannot receive proper medical treatment for a number of very serious illnesses. Practically half of the EU population is excluded from the most effective treatments for cancer, Hepatitis C and other life-saving medicines simply because they (nor their public health systems) cannot pay for them. Despite this fact, there is no clear political reaction to this situation, not even an organized debate nor a coherent search for policy proposals, studies or pilot programmes. Surprisingly, this situation is rarely considered a political and moral scandal. Health inequality is not usually considered any less acceptable than general social inequality. Unfortunately, EU supported austerity measures that have forced health-care budget cuts have made this bad situation even worse.

After many meetings this week with the health attachés from a number of important EU member states that are members of the Council´s working groups on pharmaceuticals and public health, I have reached the depressing conclusion that to date initiatives on the price of medicines and new health-driven innovation models are practically non-existent in the institutional sphere. None of the major EU member states recall ever having discussed any innovation or pricing alternatives to the Pharma patent monopoly driven model. This is in a context in which a number of these same countries admit that their states either cannot afford to buy some of the best life-saving treatments or they are forced to ration them to a small percentage of the patients who need them.

It is surprising that while there are legal EU price caps on telephone roaming rates and data roaming, no one proposes controlling prices of life-saving medicine prices. And it is not just a question of competences but of political will to place health first ahead of the dominant “growth, jobs, innovation” rant.

While there have been some political and parliamentary rumblings that complain about the high price of some medicines, namely the Hepatitis C cure Sovaldi, there are no concrete, viable proposals on the official political table that could bring down the price of life-saving medicines and/or promote new biomedical innovation models driven by real health needs. On the contrary, there are a number of serious proposals on the EU short-term agenda (medicine price Directive, TTIP, greater IPR protection, “personalized, innovative medicines”..) that could even make it more difficult in the future to bring down the price of medicines or introduce health-driven innovation models.

“Access to medicines” is usually understood by the European Commission, EU member states and other policy makers as meaning making new products “available for patients”, getting them “on the market” or “over the regulatory hurdles”, never about being affordable. Aside from some occasional rhetorical, lip-service about patients needs, pharmaceuticals is seen primarily and secondarily as issue of “growth, jobs and industrial innovation” rather that a public good. No one at all contests the constant official EU equivalency of stronger, longer patent protection and data exclusivity with “innovative medicines” nor objects at all to the coupling of high medicine prices with the high research costs of a new generation of “personalized medicine”. There is no consideration of protecting the “public return” of massive public investments in biomedical R and D nor preventing the privatization of public health-related knowledge. The pharma mantra is so pervasive that often European Commission officials from DG Enterprise, DG Research and DG Sanco are “more catholic than the Pope” in defending industry orthodoxy on IPR, transparency and high prices. A rather minor example: the EU policy to promote “open data” research with EU finding has just excluded any research related to health because it would be “too controversial”. The ideological, regulatory and legislative capture by the pharmaceutical industry is almost complete in Brussels with very few exceptions such as the inconclusive, partial victories such as the Regulation on clinical trial transparency.

A few issues now on the table in the EU Council and in the European Commission:

1. Joint Procurement: France has proposed pooled procurement solely to purchase Hepatitis C treatment Sovaldi. It is not at all clear if this will ever materialize. A number of countries have shown an interest in this initiative but there is a reluctance to share information and many countries such as Spain or France itself have gone on to negotiate secret agreements with the company Giliad on their own. The success of this initiative is very doubtful because of the lack of openness.

2. Transparency of prices: The Directive on medicine prices (now being considered by the Council) is all about the Pharma industry having access to government procurement processes and health technology actions in each EU member state so the Pharma industry can be able to take action against the lowering of prices on “innovative medicines”. It is not at all about the publication of the real prices each member state pays Pharma for medicines. These procurement prices are kept secret. As a result, the pharmaceutical industry knows perfectly well the prices and conditions negotiated by each European state while each government negotiating prices is totally in the dark about the prices paid by neighboring European countries. By “divide and conquer” the industry is at a great advantage in negotiating prices.

3. TTIP and pharmaceuticals: like everywhere else, the pharma wish-list – all oriented to market-driven innovation, high prices and higher IPR protection is very present at the negotiating table for both EU and US negotiators.