by Peter O'Donnell
BRUSSELS, 29 Nov (APM) - The meeting of the EU health council on 9 December will not discuss health technology assessment in depth, despite two years of exchanges among national officials over the European Commission's proposal for closer coordination among member state processes.
HTA is reduced to a mention under 'any other business' in the meeting's agenda, following the collapse in October of talks in the council working party and the reported search for a compromise on diluted ambitions for coordination.
This has provoked the research-based pharmaceutical industry to fire off a sharply-worded warning against a weakened solution.
On Friday, EFPIA expressed strong concerns "over the risk that EU member states will opt for what will inevitably lead to an inefficient system of joint clinical assessments".
The envisaged dilution "will create duplication and fail to address the current fragmentation across EU member states in the assessment of clinical evidence".
"A well-functioning European capacity for joint assessments is essential," says EFPIA.
It highlights the statement by Europes incoming health commissioner, Stella Kyriakades, during her hearing, that she intended to "find a way forward for this consensus for health technology assessment" and that "it's become obvious that the voluntary way is not working. We need the standard and we need to move forward".
EFPIA's Director General, Nathalie Moll, said: "An unpredictable system whereby member states decide on a case by case basis if and how they commit themselves to use jointly conducted clinical-scientific assessments will not facilitate more efficient access, but will delay it further."
Instead of a full discussion of HTA, ministers are being invited to discuss a broad-ranging note from the Finnish presidency as the basis for a policy debate on 'European pharmaceutical policy - strengthened cooperation and coordination with the aim to improve access to medicines'.
This consists of a lengthy exposition of EU law relating to medicines, and a history of reflections on the subject over the last three years in the Council, the European Parliament, the Commission and the European Medicines Agency.
It also provides a blow-by-blow account of the EU authorisation process for medicines and the typical product lifecycle.
The note focuses on shortages, and asks ministers to reflect on what measures could member states and the Commission take "to ensure access to both old and new medicines for national healthcare systems and patients, and to avoid problems caused by shortages".
It also asks whether there a need for EU legislation "to require back-up manufacturing capacity, earlier notification of interruptions and stronger measures to ensure continuity of supply".
And it wants to know how ministers think that strengthened cooperation between member states and related coordination of monitoring could mitigate problems.
The presidency's background note is also heavily laced with implicit - and sometimes explicit - criticism of the current relationship between the pharmaceutical industry and national authorities: "A balanced overall outcome leading to improved access to medicines has so far not been achieved," it says.
It comments adversely on "different levels of access to new medicines due to market failures, high prices and companies' marketing strategies".
It speaks of "an urgent need to focus on incorporating health objectives into all policies that have relevance for access to medicines, including research, innovation, trade and competition policies and on efforts to find new ways to strengthen the strategic cooperation between Member States."
There is a tangential warning in passages such as "the pharmaceutical sector constitutes no exception to the application of EU competition rules as regards anticompetitive conduct by companies or the control of mergers and acquisitions".
Similarly, a hint of action lies behind: "Pharmaceutical companies place their new products on the market at different times in different member states, despite having been granted marketing authorisation through the centralised procedure and despite having benefited from European incentives for the development of medicines."
It is important, it says, "to monitor whether EU measures have the intended impact and to evaluate pharmaceutical policy at EU level and its objectives".
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