Pharma faces outcome of EU balancing act
pharmafile | October 21, 2003 | News story | |Â Â Â
Negotiations on the future of the European pharmaceutical industry have stepped up a gear after a crucial vote in the European Parliament in Strasbourg.
The vote has taken the proposals one step closer to becoming law, and contained a mix of good and bad news for the industry as MEPs and the European Commission sought to balance what are seen as the competing interests of patients and industry competitiveness.
MEPs voted on hundreds of separate proposals, but a handful of issues are now emerging as the most contentious. The MEPs voted to:
- Throw out Commission plans to launch a pilot project allowing pharmaceutical companies to provide HIV/AIDS, diabetes and asthma patients with information on their disease. Many MEPs feared it would be the first step towards US style direct to consumer advertising, despite assurances to the contrary.
- Standardise data protection periods across the EU to eight years. After this period, generic manufacturers would have time to prepare their version for market which they could launch two years later, when ten years had elapsed. This is a compromise between the shorter periods put forward by some MEPs, and the Commission '10 plus 1' model which had won the support of industry body EFPIA.
- Support plans to make product authorisation through the EMEA's centralised procedure mandatory. This proposal has been strongly opposed by the industry since it was first put forward by the Commission in July 2001. Intensive industry lobbying appeared to have persuaded health committee MEPs to oppose the move, but the full house approved the plans nevertheless. A major factor behind this was a new amendment protecting small to medium-sized companies from excessive marketing costs.
- Establish a pharmacovigilance database on side-effects and post-marketing conditions, allowing different levels of access of regulatory bodies, health professionals, companies and the general public.
- Introduce an analysis of a new drug efficacy, adverse reactions and 'implicity of administration' compared to existing treatments.
This last proposal, along with several others with the same aim, has aroused great opposition from the industry. An EFPIA spokesman said: "The industry is deeply concerned by a series of amendments that would add new requirements on top of the 'three pillars' of quality, safety and efficacy increase costs and patient access delays and which, if they were adopted in EU law, would seriously undermine industry's ability to deliver new products to patients in a timely manner."
Lobbyists including the pharmaceutical industry are now re-grouping after the vote, and still have the chance to influence the final outcome of the process.
The proposals now go back to the Council of Ministers (drawn from member state governments), which has the power to force MEPs to re-consider the original proposals. It is known that the UK Government, for instance, is keen to see the mutual recognition system and the expertise of national agencies such as the MCA retained to ensure existing high standards remain.
Erkki Liikanen, European Commissioner for Enterprise, has indicated that he is not prepared to compromise on some issues in particular the liberalisation of information to patients. However, because of the importance of both health and industrial competitiveness issues, extensive bargaining and compromises will emerge by the time the legislation is due to become law in 2004.
Mr Liikanen told MEPs before the vote: "I do not believe that European industries have been losing market share, that there are less innovative medicines and research in this field, and that this is in the interests of European patients. I just do not believe it."
He added: "We must try to accept that there are two or three public goods we can defend at the same time. Public health takes top priority but we must also support research innovation in Europe."
