European reforms will speed up access to new drugs
European parliamentarians have agreed to revised pharmaceutical
rules
(PA Photos) |
Agreement on reformed European pharmaceutical legislation was reached in the European Parliament on 17 December 2003. The reform, first proposed
in July 2001, updates and consolidates European Regulations and Directives
that have been introduced over a number of years. The new rules are
expected to improve and speed up access to new and innovative pharmaceutical
products.
Changes to be introduced include a fast-track European Agency for the
Evaluation of Medicinal Products (EMEA) authorisation procedure, conditional
authorisation for products and a harmonised data protection period in
order to reward innovation. There will be clearer rules and procedures
for generic manufacturers, which will be allowed to start testing their
products in advance of patent expiry.
Compulsory central authorisation through the EMEA will be extended from
biotechnology products to medicines to be used to treat AIDS, cancer,
diabetes, neurodegenerative disorders and orphan diseases. After four
years this will be further extended to include treatments for autoimmune
and viral diseases.
Conditional one-year authorisation will be possible for new products
expected to be of significant therapeutic benefit. Companies will have
to undertake to carry out further studies for review at the end of the
conditional authorisation period. New medicines might also be made available
in advance of full authorisation on a compassionate basis. This is intended
to allow compassionate use anywhere in Europe when clinical trials are
geographically restricted.
The new data exclusivity rules mean that generic competition will not
be allowed until 10 years after authorisation of the original product,
with the possibility of an additional year of market exclusivity if a
new indication for the original product is authorised. The research-based
pharmaceutical industry has had to accept that generics manufacturers
will be allowed to develop their products and gain authorisation before
expiry of the 10 or 11 years of market exclusivity so that they can market
their competing products as soon exclusivity ends.
Data exclusivity will also be introduced for over-the-counter medicines,
with manufacturers who generate data to justify prescription to OTC switches
being given a guaranteed one-year head start over their rivals, with
the possibility of a second year for a new indication. The UK Medicines
and Healthcare products Regulatory Agency currently allows manufacturers
a three-month advantage.
Although the European Association for the Self-Medication Industry (AESGP)
welcomes the change, it is disappointed that only one or two years’ data
exclusivity has been granted.
AESGP director-general Hubertus Cranz said: “Unfortunately, the
compromise allows only one year instead of three years as proposed by
the European Parliament and will therefore not maximise the innovative
capability of the self-care industry.”
The Proprietary Association of GReat Britain, however, is pleased overall.
Gopa Mitra, head of public affairs, said: “It’s a little
disappointing that the exclusive period is only one year — we were
hoping for two or even three years. But one year is better than nothing
and is more than the three months currently given by the MHRA.”
“Even though this package does not fully meet the needs of the
research-based pharmaceutical industry, we recognise that compromises
had to be made,” said
Brian Ager, director general of the European Federation of Pharmaceutical
Industries and Associations. “It is now in everyone’s interest
to avoid any delay to the implementation of this important legislation,
which will set in place a pharmaceutical regulatory framework to meet
the needs of all 450 million citizens in the enlarged European Union.
An Association of the British Pharmaceutical Industry spokeswoman said
that the compromise agreement is one with which the industry is happy.
Ratification of the agreement now lies with the EU’s Council of
Ministers. |
The
Pharmaceutical Journal