by Peter O'Donnell
BRUSSELS, 7 Sept (APM) - The European discussion on pricing and reimbursement of medicines will return to centre stage on Monday as European Union health ministers convene in Vienna with a sharply critical focus on "high-priced medicines".
The two-day meeting is scheduled to cover drug regulation, drug supply and digital health.
A session entitled "Regulatory and policy-related challenges in securing supply of centrally authorised medicines" aims to lead ministers towards "relevant and concrete measures" through interaction between marketing authorisation agencies and health ministries.
A background paper that the Austrian presidency of the EU Council has circulated to ministers before the meeting, seen by APM, highlights "a significant increase in spending for high-priced medicines, particularly in the hospital sector" and what it describes as the growing differences between member states in terms of availability.
It also notes that "evidence from recent studies shows many newly authorised drugs do not provide any (additional) patient-relevant benefit".
The backgrounder summarises EU reflections on access to innovative medicines since the Italian presidency in 2014, with its growing attention to affordability and the exchange between member states of information on pricing and reimbursement of medicines, and the discussions at the level of the UN, WHO and OECD.
"It is necessary to adopt a more specific approach", the paper argues. It is "absolutely essential to develop and implement regulatory measures" - although these measures will have to be "within the scope of health policy", the paper adds.
Ministers will be asked to give their views on how to optimise information exchange on the medicines pipeline - where there is currently "a lack of transnational cooperation and comprehensive exchange".
In addition, there is currently no provision for recording the dates for the actual placing on the market of authorised medicines, for disclosing "pricing models or the level of research and development expenditures", or any "awarded public research funding".
Ministers' views will also be sought on how to improve access to evidence on patient-relevant outcomes. Citing many studies criticising the effectiveness of new therapies, the presidency paper points out that at present, "life extension and quality of life are not assessed as a mandatory requirement in the course of authorisation studies".
"While reimbursement decisions are based on the evaluation of the added therapeutic benefit compared to the respective standard therapy, approval procedures require either proof of benefit compared to placebo or at least non-inferiority to the standard therapy", it observes, arguing for "an increase or expansion of the evidence criteria required for the approval of new medicinal products".
There is presidency interest in toughening up the requirements for marketing centrally authorised medicines, where "there are strong timing differences in the availability of new medicines across the EU", it remarks.
Some markets never receive a new product at all, it goes on to point out.
It comments adversely on the fact that at present, putting an authorised product on just one member state market is enough to satisfy EU rules.
The need to tighten compliance requirements for the marketing of orphan medicines is also raised. At present, the possibility of expanding the indication of approved products without a new orphan labelling procedure and thus making them suitable for a larger patient population than the original intention "is often thwarted", the backgrounder says.
Among the proposed solutions are closer cooperation on horizon-scanning and improved access to databases.
It could also "be conceivable" to access more data in the context of the authorisation procedure, including information on the amount of public money spent on the development of a medicinal product.
This "would enable a better distribution of public money or using the the public's contribution as an argument with respect to pricing", it says.
Stricter interpretation could be given on EU marketing requirements for authorised medicines, going so far as a supply requirement for the whole Union market.
To overcome the risk of companies abusing the orphan drug incentive scheme and obtaining profits beyond its planned scope, "it could in certain cases become easier to withdraw such a product’s orphan designation and to withdraw the designation earlier than originally provided for in the regulation", suggests the presidency.
The meeting will be attended by the health commissioner, Vytenis Andriukaitis, EMA executive director Guido Rasi and Zsuzsanna Jakab, WHO's Regional Director for Europe.
The discussion does not plan to deal with parallel imports or reference pricing systems, although they affect access to affordable pharmaceuticals, because these "go beyond" the scope of existing regulations.
EPFIA said in advance of the meeting that it "acknowledges the affordability challenges faced by healthcare systems", but insisted that "concerns need to be balanced against the savings made across health, social care and wider society through the use of innovative medicines."
It said it would "examine the challenges and potential solutions tabled".