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How medicines are authorised for sale and by whom
Although the Medicines and Healthcare products Regulatory Agency
and the European Medicines Agency (EMEA) do the work, neither of
them grants licences.
The MHRA is the competent authority of the UK. It liaises with
all the devolved Governments and advises the UK licensing authority.
The EMEA co-ordinates the formation of opinions by the Committee
for Human Medicinal products and passes these opinions to the European
Commission.
Even then, the opinion has to pass through a committee
of administrators drawn from the member states’ health ministries
before it can become an EC licensing decision. |
Medicines licensing in Europe operates at a number of levels with different
regulatory agencies being responsible for different types of marketing
authorisation.
The vast majority of marketing authorisations (product
licences) are granted at a national, rather than at European, level,
but with increasing harmonisation across EU member states.
Currently, there are about 400 EU-wide licences, compared with 22,000
UK licences. But, increasingly, national licences, such as those issued
in the UK by the Medicines and Healthcare products Regulatory Agency,
are the same as those issued by other national regulators.
This is because
the EU operates a mutual recognition system intended to allow products
to move unhindered between national markets.
The whole system is designed to lead to licensing by consensus, and disagreements
between member states on safety issues are rare. Nevertheless, there
is a procedure — rarely used — where votes are taken and
the majority view has to be accepted by all
involved.
“We have the right to withdraw or suspend a licence nationally,” said
Maggie Jackman, of the MHRA’s European policy team. “But
we have to notify the European Commission within 24 hours. Then negotiations
take place through the scientific committees to try to get EU-wide agreement
on a single action.”
Finally, any disagreement can be referred to the European Standing Committee
on Medicinal products for Human Use, which can decide the matter by majority
vote. But even here, most differences are resolved by agreement.
Conversely, the European Medicines Agency (EMEA) cannot act unilaterally.
Instead, it has to be asked to act by either a national regulator, the
company that markets a product or by the EC. An EMEA spokeswoman said: “Normally,
if a product is referred to us it is because there are serious differences
between the member states or there are serious public health concerns.
An example of how this works is the handling of cyclo-oxygenase-2 inhibitors
a couple of years ago. One product had a centralised European licence,
while all the others were nationally licensed. The EMEA was only able
to consider all the drugs involved as a group because it was asked to
do so. Otherwise, it would only have been able to look into the product
with a European licence. Even then, it was only asked to devise an opinion
on the risk of cardiovascular and skin reactions and so had to restrict
itself to that.
The spokeswoman said: “National products have to be referred to
us by the EC or by a member state. We can’t initiate. But if this
happens, then any resulting opinion becomes binding on all member states.”
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The number of such referalls that are being made is rising sharply.
In 2004, just five opinions were reached after referral, with six being
completed in 2005. But, in 2006, 32 opinions were finalised and the number
currently under consideration is described as “large”.
Even so, the EMEA has no scientific assessors of its own and relies on
outsourcing its requirements to the various national licensing authorities
around the EU.
Miss Jackman said: “All the work on agreeing the terms on which
products are licensed, including the work that’s done by the EMEA
to produce a European licence, is done on the basis of discussion between
scientists from all the member states.”
This means that even when the MHRA wants to change the terms of a licence
issued nationally, under the mutual recognition procedure, or a company
asks for a national licence to be amended, the relevant national licences
are changed in all EU countries at the same time.
“Very little work that we do now is purely national work. It’s
usually got some sort of dimension that involves other member states,” Miss
Jackman said.
Monitoring the safety of medicines remains a national responsibility,
although data are pooled centrally for those medicines with European
licences and there is also a European database populated with nationally
derived safety reports.
The MHRA clearly plays a leading role in the entire European licensing
system — both EU-wide licences and national licences — because
it is the lead regulator on seven in every 10 products, whether they
are to be licensed by mutual recognition of national licences or through
the decentralised procedure for simultaneous licensing in all countries
in which a manufacturer wants to sell the product.
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The
Pharmaceutical Journal