European Commission Admit To Limited Power Over Drug Pricing

The European Parliament has been debating on access to life saving medicines.

For a long time now there has been widespread concern about the affordability of new therapies and that how the European Commission has limited powers to intervene with. Commissioner Connie Hedegaard told MEPs during the debate that the EC “shares the general concern about the affordability of new medical products and the related risk of inequalities in access to medical care.

Although she was quick to stress that while the European Commission has various tools to help make innovative medicines available to patients that need it, they are unable to regulate and control the price of medical treatments. These conditions are determined by each state.

There can be no price caps imposed by the Commission,” added Hedegaard, although she suggested it may be able to act in other ways, for example by mediating the flow of pricing policy information between member states to try to “minimise negative effects on the accessibility of medicines in the EU,” or deploying a joint procurement mechanism to negotiate better prices for new drugs.

Much of the debate was centred around the new hepatitis C virus treatments; with Gilead’s Sovaldi drug and Bristol Myers Squibb’s recently launched Daklinza raising many questions about affordability of new medicines around the world. Solvadi’s 12 week treatment carries a hefty price tag of $84,000 and with it also having such a high demand the drug has made one of most lucrative launches in pharmacitical industry. Since its launch in December 2013 it has been estimated that the drug has generated $5.75 billion.

Gilead have recently announced a licensing deal with generic drugamkers to make Sofosbuvir and a combination follow available to low income countries, at a discounted rate. However the agreement excludes middle income and affluent countries. Hedegaard confirmed that a series of meetings is planned in the next coming weeks to also tackle the pricing and affordability of Hepatitis C Virus  therapies and other innovative treatments.

During the debate, concerns were expressed about the proposal by EC President-elect Jean-Claude Juncker to transfer responsibility for pharmaceutical policy away from the Directorate General for Health and Consumers (DG Sanco) under Vytenis Andriukaitis to the new DG for Internal Market, Industry, Entrepreneurship and SMEs, to be led by Elžbieta Bieńkowska.

Croatian MEP Biljana Borzen said it is notable that issues such as affordability may be covered under the trade portfolio in future, asking: “I take it that health will now be secondary to economic interests?

Other MEPs called for EU member states to start making use of compulsory licensing mechanisms to make generics available that would help reduce costs, given that more than 8 million in the EU are infected with the virus.

Concern about the switch has also been voiced by public health groups such as Health Action International and the European Public Health Alliance (EPHA), with the latter saying that the proposal was “putting the public interest behind the drive for profits in drug authorisation procedures.

Alex Carson

PiR Resourcing leaders in senior life science resourcing. For more news and information, you can follow us on Twitter and LinkedIn  For all our latest roles in the Life Science sector please click here.


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