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Volume 38, Issue 10
What will come out of Austria’s shakeup of European pharma rules?
Vienna’s tradition as a powerful European hub lives on: just like 150 years ago, when the city hosted a breakthrough meeting on the emerging technologies of 1868, it is aiming to do the same in 2018. Back then, it was the crucial International Telegraph Conference that established common regulations for international service. Right now, in the face of rapidly developing healthcare innovation, it was the location for a string of meetings intended to bring a new sense of order to the regulation of medicines.
Early in September, Austria, the current president in office of the European Union’s health council, brought to its elegant capital dozens of ministers, senior officials, and diplomats from across the continent for an ambitious and broad-ranging two-day review of norms, ranging from paying for innovative medicines to making a success of digital health. And as the month moved toward its end, Vienna again welcomed further batteries of officials in a bid to get some real action out of all the talking it generated.
The health council meeting took as its starting point the growing challenges of assuring access to innovative medicines-the focus of ministerial concern since the Italian presidency in 2014, supported in recent years also by the UN High Level Panel on Access to Medicines, the World Health Organization (WHO) Fair Pricing Forum, an Organization for Economic Co-operation and Development (OECD) Health Ministerial last year, and the European Commission’s own expert panel on investing in health. And the tone of the Austrian presidency’s attentions was evident from its formal invitation, with frequent references to “a significant increase in spending for high-priced medicines,” to “growing pressure to sustainably maintain the high quality of care in Europe,” to “differences between member states” in availability of innovative medicines, and “evidence … that many newly authorized drugs do not provide any (additional) patient-relevant benefit.”
To tackle these challenges, it is “necessary to adopt a more specific approach in the general debate,” according to the presidency. Its declared goal is “to identify and implement relevant and concrete measures.”
One such area where these “concrete measures” may be introduced, according to the presidency, is in doing something about the “often unstructured” exchange of information between approval authorities and payers,
leaving the organizations that have to pay for medicines suffering an information deficit and uncertainties over upcoming costs.
Another difficulty identified by Austria is “the fact that there is no mechanism to disclose pricing models or the level of research and development expenditures”-subjects where information is “often hampered by confidentiality clauses.” Access to information on public money spent on the development of a medicine would make it possible to use the public contribution as an argument in pricing negotiations, it says.
Elsewhere, the presidency highlights criticisms about inadequate levels of evidence to demonstrate patient benefit, studies suggesting limited value in newly authorized drugs, and weak criteria for pricing and reimbursement decisions. Expanding the evidence criteria for approving new medicines could ensure that additional patient-relevant outcomes are measured in the approval process, it suggests.
The presidency focused particular attention on questions of wide availability of new medicines. “Despite the fact that the vast majority of innovative medicines are centrally approved, there are strong timing differences in the availability of new medicines between the EU member states,” it says. “Significantly deferred” market launches in some member states average up to two years after the granting of authorization, it complains. In other words, the current EU rules do not provide adequate supply requirements for the whole EU market. One recommendation the presidency makes is for a stricter interpretation of the existing rules so that manufacturers would risk losing their authorization if a new medicine was not widely marketed. This, it says, “could provide an additional incentive to speed up the market launch of authorized medicines in Europe.”
What are seen as malfunctions of the EU’s incentive schemes for drug research also come under the Austrian spotlight. It homes in on the lack of control on some manufacturers’ use of the orphan drug scheme to gain unjustified advantage from it. One of the targets is “the fact that it is possible to extend therapeutic applications for active substances with orphan designation at any time without a new authorization procedure.” The active substance may be used for a much larger patient population than originally indicated in the application for orphan status, and the revenues generated cast doubts on the eligibility of such products for favorable financial treatment, in the presidency’s view.
On digital health, the Austrian concern is that Europe is still far away from exchanging data across all areas of their health systems, and insufficient use of the potential benefits is being made. Barriers to interoperability in standards, formats, compatibility, reliability, or accessibility have not been overcome. As a result, the objectives for optimizing care and research will remain unattainable, it warns.
In addition, Austria is continuing to work toward agreement on the proposed-and highly contentious-new rules for coordinated health technology assessment, and to promote the adoption of a recommendation on strengthened cooperation against vaccine-preventable diseases.
To push forward this ambitious agenda, Austria recalled senior EU officials to Vienna for several working sessions in late September. A meeting of national directors responsible in each of the member states for drug policy started by exploring how to improve the availability of medicinal products-and included discussions on incentives in the pharmaceutical system, and “a strategic discussion on the importance of the pharmaceutical policy for current political debates.” The problem of access in specific European markets featured prominently, with particular attention to the supply obligations, following up on the informal council meeting.
This was followed by a session with the broad title of “Matching Health Needs and Pharmaceutical Research-How to Set the Research Agenda for Public Health.” The costs of R&D of pharmaceuticals are often co-financed by public funds, but because public health authorities have insufficient knowledge of the global structure of companies’ R&D funding, they cannot actively steer research toward unmet medical needs, said the presidency. So it wants to create a platform to improve exchange between national health and research administrations, universities, funds, and international organizations.
There were also meetings in Vienna of a cooperation mechanism among European medicines agencies on legal and legislative issues, the coordination group of national medicines agencies for mutual recognition and decentralized drug authorization procedures, the Network of Competent Authorities on Pricing and Reimbursement, and “learning meetings” of the EMA’s Pharmacovigilance Risk Assessment Committee, its Pediatric Committee, and its Committee for Medicinal Products for Human Use.
How much will all this achieve-above all in the three months that now remain until Austria hands its presidency over to Slovakia? Closer cooperation among national authorities on information relating to pricing and reimbursement is already underway in pockets of Europe, but has yet to translate into any impact on decision-making, because negotiations on each product remain a national matter between government and manufacturer, cloaked under deep secrecy over the terms-and neither side at present seems ready or able to break that tradition. Methods for evaluating new drugs are in constant evolution, but any change in the rules would require legislation-and that would, in turn, depend on a consensus on approach that does not at present exist. Similarly, tightening marketing obligations so companies have to launch their drugs everywhere in Europe looks at present a non-starter: the most recent official EU pronouncements have been very negative about the concept.
The review of incentives is a live issue that is already in progress, but is unlikely to result in much more than tweaks to the current system. And on digital health, any movement there depends more on national engagement than on any edict from the EU level.
Reflector is Pharmaceutical Executive’s correspondent in Brussels