News release
“Reduce Red Tape For Medicines!”
Urge Members of the European Parliament
Brussels, Belgium, 03 October 2002: Members of the European Parliament’s Environment Committee today voted overwhelmingly to recommend the removal of the requirement for 5-yearly licence “renewals” and install a strengthened Pharmacovigilance system instead, going even further than the Commission’s original proposals. This vote sends a strong message from the MEPs that reducing unnecessary bureaucracy in the EU’s medicines registration system is a vital component of solving the veterinary medicines availability crisis.
“The European Parliament has taken a great step forward in the right direction,” commented Bill Hird, member of the FEDESA Board of Directors. “Because as long as we have fixed period “renewals”, we will have a veterinary medicines availability crisis. Repeatedly requesting new data at five-yearly intervals, irrespective of whether there are any grounds for health concerns, means that many products were simply not being renewed. If the sums don’t add up, and the small sales of animal medicines – from what is, essentially, a series of very tiny markets – do not justify the investment in data development, then products will simply be lost from the market. The Parliament’s call for increased, on-going in-use surveillance instead will be a much better way to guarantee both public health and animal health.”
The largely bureaucratic requirement to resubmit licenses for re-approval every 5 years has been widely criticised for diverting scarce R&D resources away from developing new medicines, without contributing significantly to improvements in safety. This has not only contributed hugely to the veterinary medicines availability crisis, but has also put European companies at a strong disadvantage compared to their US counterparts, who, lacking “renewals”, need to invest much less of their R&D budgets in resulting “standstill” research. The MEPs’ have wholeheartedly supported the Commission’s proposals to delete “renewals” and instead have demanded a vastly strengthened and better-coordinated Pharmacovigilance system, going even further than the Commission’s original proposals. Specifically, the Environment Committee has called for:
- Both public and corporate funding for pharmacovigilance activities;
- Public access to pharmacovigilance data;
- Mechanisms to increase reporting of pharmacovigilance data from the field;
- Establishment of an explicit legal basis for pharmacovigilance compliance inspections; and
- Penalties, coupled with a “name and shame” policy for companies that do not fulfil their post-authorisation obligations.
Assuming formal adoption at the Plenary vote scheduled for 22 October in Strasbourg, the Parliament’s recommendations will be forwarded to Member States representatives on the Council. “It is now in the hands of the Member States,” continued Mr. Hird. “And we hope that they will support this resounding endorsement of strengthened pharmacovigilance, rather than renewals, as the right way forward.”
If they find their way onto the EU’s statute book, these provisions will form an integral part of the strategy to combat the current medicines availability crisis, while at the same time ensuring the highest level of consumer-, animal- and environmental safety. “These provisions will ensure safety is the number one priority,” explained Mr. Hird. “However, the animal health industry is not complacent – improved pharmacovigilance is only part of the answer. Marketing authorisation holders must also review their procedures for keeping dossier up-to-date with timely "variation" applications. The animal health industry sees improvements in post-authorisation dossier compliance as the second key area where we can make a positive contribution. This is why FEDESA is considering developing an industry standard for Good Regulatory Practice. We want to actively support [Commission] proposals that aim at making the regulatory system less wasteful of resources and products while at the same time maintaining appropriate levels of safety for consumers, animals and the environment."
Ends |
