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25 November 2009
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Parliament rejects medicines advertising 

Published: Thursday 24 October 2002   

On 23 October, the European Parliament in its first reading of the pharmaceutical review proposals, said "yes" to centralised authorisation procedure of new medicines. MEPs rejected direct advertising of pharmaceutical products and supported earlier market access of generic medicines.

Background:


In July 2001, the Commission adopted a proposal for a comprehensive reform of the EU pharmaceutical legislation. The Commission proposal for reform particularly concerns Regulation 2309/93 that provides the legislative framework regulating medicinal products, Directive 2001/83 (on human medicines), and Directive 2001/82 (on veterinary medicines).

On 2 October 2002, the Parliament's Environment Committee amended the Commission proposal on two main issues: information to patients and authorisation of generics (see also

EurActiv, 4 October)

The primary objective of the Pharma review is to achieve a high level of health protection in Europe while at the same time boost the competitiveness and innovative capability of the European pharmaceutical industry.

 

Other related news:


The main results of the Parliament's first reading were the following:

  • Support for a central authorisation procedure, via the European Agency for the Evaluation of Medicinal Products, for all new medicines;
  • Rejection of the initial Commission proposal for a pilot project to allow information to be provided on new drugs to treat diseases such as AIDS, asthma and diabetes;
  • Support for the the EP Environment Committee's 8+2 years data protection proposal, meaning that generic medicinal products would be eligible to apply for authorisation 8 years after the reference medicinal product is approved, while the production and marketing of the generic medicinal product authorised on this basis would have to wait an additional two years.

 

Positions:


EFPIA, the European Federation of Pharmaceutical Industries and Associations, welcomed Parliament's decision to rethink how information should be provided to patients. EFPIA expressed disappointment regarding the centralisation of medicines authorisation. EFPIA also regretted MEP's decision to allow the generics industry to request authorisation sooner, hence expediting their market entry.

The Association of the British Pharmaceutical Industrysaid that the current ban on drugs advertising was "unfair" and "not in patients' interest".

Consilient Health, a generic drug firm, referred to the Parliament's vote on regulatory data protection as a "fair compromise".

BEUC, the European Consumers' Organisationwelcomed the Parliament's decision to "favour informed choice for patients instead of just more brand awareness". BEUC, in their press release thanked the Parliament for placing "the interests of patients before those of the pharmaceutical industry".

 

Next steps:


The pharma review package will be discussed by the Council on 2-3 December.



 

Links

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Genon Jensen, Executive Director, Health and Environment Alliance
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