European Commission ‘has limited power to tackle drug pricing’

A debate in the European Parliament on access to life-saving medicines has heard that while there is widespread concern about the affordability of new therapies the European Commission (EC) has limited powers to intervene.

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.”

However, she stressed that while it has various tools to help make innovative medicines available to patients, the Commission “has no competence to regulate the prices of medicinal treatments,” as these are determined by member states individually.

“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.

Unsurprisingly much of the debate centred on new hepatitis C virus (HCV) treatments – Gilead Sciences’ Sovaldi (sofosbuvir) and also Bristol-Myers Squibb’s recently launched Daklinza (daclatasvir) – which have raised questions about the affordability of new medicines around the world.

Sovaldi’s $84,000 price tag for a 12-week treatment along with pent-up demand for the new drug has made it the most lucrative pharmaceutical launch of all time, generating $5.75bn in the first six months of the year after being launch in December 2013.

Gilead has just announced a licensing deal with generic drugmakers to make sofosbuvir and a combination follow-up available to low-income countries at a discounted rate, but this agreement excludes middle-income and affluent countries.

Hedegaard confirmed that a series of meetings is planned in the coming weeks to also tackle the pricing and affordability of HCV therapies and other innovative treatments. A Commission working group met yesterday to discuss the issue, and a debate on the topic is also scheduled to take place during an informal meeting of health ministers on 22-23 September.

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.”


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