BRUSSELS, Dec 17 (APM) - The European Commission on Wednesday revealed it is to withdraw its proposal to update the EU’s 1989 rules on how national authorities must act when they make their decisions on pricing and reimbursement of medicines - leaving unresolved many contentious issues that have risen higher up the agenda over the five years since the Commission mooted the modernisation.

The proposal - which included provisions to speed up national decision-making, separation of intellectual property considerations from pricing decisions, and even scope for companies to seek redress for undue delays in reimbursement decisions - has fallen victim to a planned clear-out of nearly 100 draft measures that the new Commission wants to eliminate because they are redundant, obsolete or stalled.

The announcement that the update to the so-called transparency directive is to be withdrawn came as part of the Commission’s workplan, revealed on Wednesday. Technically, the proposal is entitled “the commission proposal for a directive relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems” - the transparency referring to requirements for national authorities to operate via decision-making procedures that are clear for all to see.

The plan to update the rules goes back more than five years. In 2010 the Commission decided that a review was overdue, and it organised a public consultation in 2011.

This resulted, in 2012, in the formal proposal. The draft was debated at length in the EU’s Economic and Social Committee and the European Parliament. Consideration of the text also commenced in the EU’s council of ministers, but repeated efforts to find agreement among member states proved fruitless.

Even last July, at the start of the current Italian presidency of the council, officials and diplomats said they would be aiming to advance the discussions. But the ambition was abandoned early in the presidency in the face of overwhelming member state resistance.

The proposal explicitly aimed to preserve the competences of member states in the field of public health - since the treaty leaves them free to make their own decisions on health matters. The EU has powers only to influence how those decisions are made - not the substance of the decision itself.

But it equally explicitly noted that a balance had to be struck “to ensure timely and transparent decisions”. And this took the Commission into sensitive territory.

The measure would have enlarged the scope of the 1989 rules so as to cover a wider range of member state decisions.

And it aimed to cut sharply the time allowed for national authorities to make their decisions. They would have had to make pricing decisions in 60 days (and 15 days for generics), and 120 days for reimbursement (and just 30 days for generics).

The multiple objections of member states to many of these provisions paralysed progress, and the Commission’s workplan says the proposal is being dropped because there is "no foreseeable agreement".

The Commission is expected to start looking for answers to some of the questions it posed when it made its 2012 proposal. But this will be a slow process, since the new Commission is still feeling its way in policy terms, and pharmaceutical policy has not yet been addressed in any comprehensive fashion by any of the departments that now share responsibility for it.

All the relevant departments are currently open to views on how to move ahead - and not just on pricing and reimbursement procedures, but on many of the other issues that a comprehensive pharmaceutical policy might cover.

A series of “stakeholder meetings” and events is foreseen for the new year at which industry, regulators, patients, academia and civil society will be invited to contribute further views.

pod/hlc