Europe delays ban on animal-derived products
This article was originally published in Clinica
The date on which the European ban on the use of high-risk animal materials in medical products will be brought in has been postponed by three months until March 31.
The move, by the European Commission, follows the advice of its scientific steering committee which has recommended extending the scope of materials covered by the ban at the same time as proposing less strict rules for regions free from BSE.
The Standing Veterinary Committee did not vote on the Commission's draft revised decision on the ban during its meeting on December 9 as had been expected, nor on the possible derogations and transition periods for the ban on so-called specified risk materials or SRMs. It will discuss these this week along with the proposed delay of the whole SRM ban.
The European Confederation of Medical Devices Association believes it would not benefit from the concessions proposed in the European Commission's draft revised decision on SRMs in the same way as the diagnostics industry, if indeed they go through.
The revised ban would in theory allow the use of SRMs if medical device manufacturers had prior government authorisation. But this would be unlikely to happen much, if at all, EUCOMED director general Michael Baker told Clinica.
. . . further exemptions unlikely
"There could be future derogations for medical devices from one or two member states which are BSE-free, but for countries where the decision is applicable it is highly unlikely that there would be any further exemptions," he said.
EUCOMED would be advising its members to work to the regulations specified in Annex 1 of the revised draft, Mr Baker said. Annex 1 states that medical device manufacturers will be able to continue marketing products containing animal materials with specific risk materials until January 1 1999, a year after the ban on such products takes effect, as long as their products are authorised before the ban comes into force.
Proposed delays to the ban are being discussed again by the Standing Veterinary Committee. A six-month delay had been anticipated, but the Commission chose to propose a year's delay after the ban to allow competent authorities and industry to adapt to the new situation. In the meantime, member states would need to take measures to ensure full implementation by January 1 1998.
The revised draft also foresees an extension of the ban's deadline for medical devices in specific circumstances. They are:
* tissues or liquids from bovine, ovine or caprine origin that are only indirectly associated with, or disappear from, the manufacturing process can be used until June 30 1999, except for where there are no satisfactory therapeutic alternatives, when the deadline is December 31 1999. Stocks of such products which have been manufactured during the above transitional periods may be used up until the expiry of their shelf life.
* tallow derivatives could be used provided they are produced following an appropriate, validated and strictly certified method.