Regulatory Review - Vote in
Parliament
The European Parliament plenary vote on Vet Review 2001 took place in
Strasbourg on 23 October. There is some good news for the availability of
animal medicines, some less good, and still a lot of work to be done as the focus
of activity moves to the Council of Ministers. Some major successes from
the European parliament's Environment Committee vote have been ratified by
the plenary vote. These include improved data protection, and maintaining
national routes of distribution for certain food-animal products.
The one significant change between the committee and the plenary vote
was in relation to 5-yearly renewals. Renewals cost licence holders a
significant amount of time and expense and are therefore a contributory
factor in the medicines availability crisis as, especially if the market
for specific products is small, then the licence holder cannot justify the
costs of licence renewal. Hence, sadly, products are lost from the market
as it is not commercially viable to continue. Animal medicines
manufacturers would rather have an ongoing and improved pharmacovigilance
system. Rather than deleting renewals completely, the EP voted to retain a
single renewal after the first five years. However this was balanced by
some improvements to business flexibility. Full flexibility in the choice
of procedure has yet to be secured, but as the Council support
flexibility, this may be one issue that will only be resolved in the later
steps of the co-decision procedure.
After voting on the individual amendments tabled by MEP's to the
legislative changes proposed by the Commission, all three reports were
adopted by a large majority. These will now be forwarded to the Council
for the second step of the co-decision procedure.
1. Data Protection: the harmonised 10 year period was adopted, but with
a clause to allow generics to submit an application for a marketing
authorisation in year 8. The additional data protection was extended to
cover all species and new indications, as FEDESA had requested, and the
deadline to obtain these Marketing Authorisation extensions was extended
to 5 years.
2. Scope of the procedures: the amendment to delete the proposal for
all new active substances to use the centralised procedure, and an
amendment to define a new active substance as having a new chemical
structure, were rejected for both human and veterinary medicines. (This
overturned the Environment Committee's adoption of a clause allowing an
opt-out for human medicines).
3. Sunset clause: (ie, the deadline for bringing new products to the
market after the MA has been obtained)this was extended from 2 to 3 years,
with a derogation for exceptional circumstances e.g. medicines for rare
diseases
4. Renewals: an amendment to initially limit the validity of a licence
to 5-years, followed by an indefinite licence after a one-off 5-year
renewal, was adopted.
5. Prescription only medicines: a favourable amendment was adopted to
allow a derogation for suitably qualified people to dispense POM products
according to national legislation. This would allow the PML system to
continue in the UK. This is an area, the so called Article 67, in which
NOAH as an association and through the 'Animal Health Alliance', has
tackled assertively. Their view is supported by the VMD, and the adoption
of this amendment marks a very positive outcome from intensive lobbying.
The Commission's proposal to require all new products to be POM for the
first 7 years was changed to the first 4 years, with the
"unless" clause reinstated to allow for exemptions.
However, the amendment which would ban all advertising of POMs to the
'general public' was adopted, as was the amendment restricting medicines
to therapeutic use. It is not sure at this stage whether farmers would be
regarded as 'general public' or professionals in the food producing
industry!. However it could mean the end of NOAH members' support of
veterinary surgeries in producing wormer leaflets, vaccination
reminders/certificates etc. If so, NOAH believes it could have a
detrimental effect on companion animal preventative health programmes.
There were some other important proposals adopted, including some to
help the horse issue: the Parliament endorsed two additional amendments
proposed by Avril Doyle MEP that could solve at least part of the
long-standing problem of availability of horse medicines. The first amends
the definition of food-producing species. The second is a derogation which
will allow the marketing of products to be used in sport and leisure
horses and containing substances not included in Annex I, II or III of
Regulation 2377/90, i.e. those products not having an MRL
NOAH Ltd
13 November 2002 |
