Friday, December 5, 2008

Pharma package seen for Dec 10

The European Commission will present the much-delayed “pharma package” on December 10 at a press conference.

Ton van Liero, spokesman for Gunter Verheugen, European Commissioner for Enterprise and Industry, told me, “We foresee a press conference on Wednesday on the pharma package.”

Moreover, the Commission announced that the College of Commissioners (27 Commissioners) will be presented with it next Wednesday.

Commission spokesman Amadeu Altafaj Tardio told journalists: “On the agenda of the Commission meeting next Wednesday, will be a major pharmaceutical package. It has been subject of many draft directives, amendments, existing directives and Commission communications by Mr. (Gunter) Verheugen and various proposals and drafts and regulations, so the whole package that is for pharmaceutical industry.”

Earlier today addressing a joint press conference with health ministers from G7 countries (Canada, France, Germany, Italy, Japan, UK, US), Mexico and the World Health Organisation, European Health Commissioner Andrroulla Vassiiou also had expressed hope that the pharma package will come out soon.

The Commissioner was hosting Global Health Security Initiative (GHSI) to forge stronger global collaboration on health security.


Replying to a question about disagreements within the Commission, Commissioner Vassliou said, “It (Pharma package) is one of the most difficult packages and it is natural that all cabinets are very interested about it and there is a lot of discussion so that our purpose is to reach a final agreement on a package which will be in agreement with everybody,” adding, “I am hopeful that it will come up with something which will be satisfactory to everybody and useful to everybody.”

The European Commission has repeatedly delayed since October 21, the publishing draft regulations which could overhaul the pharmaceutical sector, amid rumours that divisions within the Commission are leading to the delays.


European Commissioner for Enterprise and Industry Gunter Verheugen had denied that his package of proposed new regulations for the pharmaceutical industry will be substantially altered despite its publication being delayed but APM understands there are disagreements within the College over such subjects as banning the repackaging of medicines, which is widely practiced by parallel traders.

The pharma industry has been pushing to ban repackaging of medicines saying it is the only way to stop trade in counterfeit products.

But supporters of parallel trade believe it could damage the legitimate practice of traders buying low-price drugs in markets such as Greece and selling them at a profit in other countries where they can command a higher price.

A report published recently on the website of the Commission's directorate general for Enterprise and Industry said that repackaging and relabelling medicines posed an inherent risk to patients but banning the practice would result in a dramatic reduction in the level of parallel trade and in the loss or redeployment of some 10,000 jobs across Europe.

The sources recently told me that a revamped package is now being prepared that will not ban repackaging. "Those proposals are history," said one.

This is in line with comments from a Commission spokesman earlier. "There is no ban foreseen on repackaging or relabelling ... Parallel trade is a legal economic activity in the European Union (and) the commission does not intend to change that."


But other measures in the pharmaceuticals package are also controversial, such as a proposal to allow companies to provide information on their drugs to patients, which some commentators believe is tantamount to permitting direct-to-consumer advertising.

The Association Internationale de la Mutualité, Health Action International (HAI) Europe and Medicines in Europe Forum today in an open letter to European Commission President Jose Manuel Barroso said: “The proposals on “information to patients” represent yet another tactic to delay generic competition by enabling the pharmaceutical companies to communicate directly to the public on their respective prescription-only medicines, thereby building "brand loyalty" and market share for their own originator products at the expense of affordable medicines for the public.”

Greg Perry, Director General, European Generic Medicines Association (EGA) had told me: "We understand the reason for the delay is due to lack of agreement on ITP (information to patients virtual network) proposal."

Perry said the EGA's main concern was now that the proposed legislation will not make it through this session of the European Parliament, particularly the pharmacovigilance package which is "a good proposal in terms of  improving patients safety, harmonisation and better regulation."

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