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Austria not giving up on search for solutions to European pharma problems

by Peter O'Donnell
BRUSSELS, 21 Sep (APM) - A new round of talks on pharmaceutical policy will take place next week in Vienna, as the Austrian presidency of the health council presses ahead with its ambition of better management of the challenges that innovative medicines pose to European healthcare systems.
As a direct follow-up to its informal health council meeting earlier in the month (APMHE 59648), Austria has convened a meeting of national directors responsible for pharmaceutical policy on 24 September, with an agenda devoted to "improving the availability of medicinal products".
"Strategies for topical questions regarding pharmaceutical policies will be discussed and developed," said Austria in a statement.
The "topical questions" it will raise cover many of the hot-button issues in European pharma debate at present.
It lists items as controversial as incentives in the pharmaceutical system, supplementary protection certificates and "the problem of access in specific European markets".
At an even broader range, Austria also plans "a strategic discussion on the importance of the pharmaceutical policy for current political debates."
Speakers at the meeting will include officials from the Dutch health ministry - where support for new approaches to control drug prices remains strong -, a former secretary-general of Doctors Without Borders and a Greek researcher working in Germany on health economics and the value of medicines.

Supply obligations

Austria says the "main focus" of its meeting will be the legal basis for obligations to supply centrally authorised medicines.
Even before its health council meeting in early September, Austria was talking of toughening up the requirements for marketing centrally authorised drugs.
In its invitation to the council, it spoke of "strong timing differences in the availability of new medicines across the EU", and pointed out that some markets never receive a new product at all.
It openly urged a review of the current EU rules, which require that a centrally authorised product need be marketed in only one member state for its authorisation to be valid.

Small country difficulties

The perceived risk for some countries - and particularly smaller countries - is that allowing drug firms to pick and choose where they market their products leaves some patients suffering long delays for innovative treatment, and maybe never able to receive them.
As far back as June 2016, the health council noted disapprovingly that "new products are not introduced to national markets for business economic strategies and that individual governments have sometimes limited influence in such circumstances."
It is no coincidence that Louis Panagi, head of the Cypriot Medicines Agency since 2007, is one of the speakers listed for the meeting.
Cyprus and Malta are two of the countries where new medicines have often arrived later than in larger markets, for a range of reasons - logistical, commercial or purely circumstantial.
But smaller countries suffering this form of neglect have been vocal in calling for regulation to require drug firms to launch their products more widely in the interest of patient access.
The Austrian invitation to the recent informal health council observed that stricter interpretation of existing EU rules "could provide an additional incentive to speed up the market launch of authorised medicinal products in Europe"
The issue featured prominently in a joint industry-health ministry meeting in Sofia during the Bulgarian presidency earlier in 2018, and provoked calls for EU action.
But APM has been told that officials from the European Commission and the European Council who were present at that meeting pushed back strongly against any such suggestions.
The EU rules provide no basis, they stated, for obliging anyone to market anything right across the member states.

Research funding

On 25 September, a presidency meeting will consider research funding, in the light of concerns that publicly funded research is not always leading to publicly useful outcomes, and at the same time is giving drug firms too much of a free ride.
'Matching Health Needs and Pharmaceutical Research - How to set the research agenda for public health' will aim to improve the exchange of knowledge between national health and research administrations, universities, funds and international organisations.
According to the presidency, "a considerable share of the cost for research and development of pharmaceuticals is co-financed by public funds."
Change is necessary "to actively steer research towards the area of unmet medical needs", it says.
The "ultimate goal", it continues, is "to better reflect the medical need when taking research funding decisions."
The cluster of health meetings in Vienna during the week will be followed by a gathering of the European Medicines Agencies Cooperation on Legal and Legislative Issues, a 'Strategic Review and Learning' for the Co-ordination Group for Mutual Recognition and Decentralised Procedures, a similar event for the EMA's Committee for Medicinal Products for Human Use, Pharmacovigilance Risk Assessment Committee and Paediatric Committee, and a meeting of the EU Network of Competent Authorities for Pricing and Reimbursement.
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