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Rapidly advancing pharmaceutical science and innovation presents new challenges


Last year I wrote a blog called “From me-too to too-much”, underlining that the pipeline of new medicines is better than ever. The results of EFPIA members rapidly advancing science and innovation are coming to fruition with recent approvals of cures for hepatitis C, game-changing cancer medicines, and medicines that reduce mortality due to heart failure or high cholesterol.

European governments and health care payers are figuring out how to introduce these innovative medicines, while staying within the budget. EPFIA member companies have demonstrated huge flexibility and willingness to engage in novel approaches, including health systems only paying when the medicine delivers the outcomes that are expected, such as fewer hospitalisations, or longer survival.

Reflecting on the industry pipeline, there is scope for much more European-level cooperation to prepare for the wave of innovative treatments on the horizon. Patients will not accept that it takes years to figure out the right price, or which patients are most in need. This has to be discussed much earlier, and why not in parallel to the regulatory review by the European Medicines Agency (EMA). The recent experience with new medicines for Hepatitis C, shows that we need a much better process to plan: what technologies are coming; how do we budget for them; and importantly, how can we track the performance so we know the money is will spent?

EFPIA is very supportive of pan-European collaboration of an early assessment of the added value of new medicines at launch (“relative efficacy”) and over time, reflecting on evidence from everyday clinical practice (“relative effectiveness”). We would also like to see a more structured and on-going process for horizon scanning allowing health systems to prepare and manage the introduction of new high impact medicines. One part of this is budget planning, but increasingly it will be about preparing for targeted/personalised medicines that require diagnostics, new care pathways and follow-up. I am happy to see these ideas becoming concrete pilots at the EMA and projects in IMI.

However, it is around the suggestion that countries should collaborate on price negotiations where I have significant reservations. The price of a medicine should reflect the value it has for society, while respecting budget and affordability. Across European healthcare there has been an increasing recognition of the benefits of competition. It not only makes companies try to get new medicines first to patients, it also gives buyers the power to choose one of several alternatives.

Price negotiations for new medicines will have to take place between a company and the person/institution which has the budget and that will ultimately decide on the use. A committee in Brussels, just to take a random location, not representing budget-holders is not ideally placed to get a good deal for tax-payers or those insured. Maybe counter intuitively I am arguing for stronger buyers, at the country level, that want to see evidence of performance in real-life. Why pay if the medicine does not deliver the expected outcomes? This is easy to say, more difficult in practice. At the end of the day, pricing and budgets is a country or regional issue. I do not believe in cross-country price negotiations.

On behalf of my members, and thinking about the scientific advances under way, now is the time for European governments and health systems to collaborate to speed up the access to new medicines, while equipping the public side with the tools to plan for funding of new technologies, assess performance of public health resource allocation and effectively negotiate with the private sector.

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EFPIA Director General

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