by Peter O'Donnell
BRUSSELS, June 15 (APM) - European health ministers will be asked on Friday to put their names to a raft of proposals relating to the pricing of medicines, in what is seen by many drug industry executives as a further - if cautious - step towards market intervention.
Draft conclusions prepared for the EU Health Council, comprising national ministers from the member states, encourage working together on prices, reimbursement, "market failure" and horizon-scanning.
Cooperation is invited between authorities and payers from member states, including "pro-active exchange of information" among national pricing and reimbursement authorities.
Joint price negotiations are also set to win support, as are "approaches to address unavailability of medicinal products and market failure situations."
Joint horizon-scanning for early alerts on upcoming medicines with a "significant financial impact on health systems" is among the recommendations.
And concerns over the possible negative impact of early access schemes are cited to justify "clear and enforceable (pre-) conditions and exit options for the products that enter the market through these mechanisms".
The same concerns lie behind a recommendation to share information on post-marketing effectiveness of medicines.
Public money ploughed into private research should have some sort of compensating mechanism, such as "equitable licensing to ensure a fair return on investment," say the draft conclusions.
The entire system of incentives for pharmaceutical innovation should be reviewed, according to the text to go before ministers.
There should be a "fair distribution of incentives and rewards," and the European Commission should, "if necessary, consider revision of the regulatory framework on orphan medicinal products."
The text "notes with concern that companies may seek very high prices while the added value of some of these products is not always clear."
And it calls for an analysis of "the effects of the pricing strategies of industry in relation to these incentives."
The EU's powers under competition law - which are very much stronger than any influence the EU is entitled to exert on health policy - enjoy prominence in the draft conclusions too.
These powers should be invoked, it is suggested, in "potential cases of market abuse, excessive pricing as well as other market restrictions specifically relevant to the pharmaceutical companies operating within the EU".
The text notes how a healthy market "benefits from vigilant competition law scrutiny".
Because the EU treaty makes no provision for influencing national decisions on drug pricing and reimbursement, the language is studiously diplomatic, and refers to "strengthening the balance in the pharmaceutical system in the EU and its member states".
The language is also more moderate than in earlier drafts, after repeated discussions among diplomats and officials (APMMA 48068).
And the text genuflects to the industry's role in generating therapies, innovation, employment and exports, and acknowledges the merits of a "strong, functioning and effective intellectual property environment."
But the principal theme of the conclusions nonetheless reflects deep and continuing concerns among many member states over the cost of drugs.
New medicines, for all their merits, "may also pose new challenges to individuals patients and public health systems, in particular regarding the assessment of their added value, the consequences for pricing and reimbursement, the financial sustainability of health systems, their post-market surveillance and patient access and affordability," says the draft text.
Conditions for early launch schemes "could be further clarified in order to improve transparency, to ensure a continuous positive benefit risk balance of medicinal products put on the market under special conditions".
Incentives "need to be proportionate to the goal of encouraging innovation," and care is needed to avoid creating circumstances "that might encourage inappropriate market behaviour of some manufacturers".
"Post-market compliance with certain obligations for marketing authorisation holders is not always optimal," it says.
The text displays concern over unequal relationships between industry and governments.
It speaks of "the lack of leverage of individual member states in negotiations with industry."
"Individual governments have sometimes limited influence" to counter the behaviour of drug firms, the text laments.
It points to "an increasing number of examples of market failure in a number of member states, where patients' access to effective and affordable essential medicines is endangered by very high and unsustainable price levels, market withdrawal of products that are out-of-patent, or when new products are not introduced to national markets for business economic strategies."
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