UK to lead on some new European medicine laws
How to comment
Comments on the proposals can be sent to Michael
Darbyshire, Review of EU Medicines Legislation — early
implementation, MHRA, Room 16-158, Market Towers, 1 Nine Elms
Lane, London SW8 5NQ (e-mail
2001Review@mhra.gsi.gov.uk) until 22 October. |
Views on plans to implement some aspects of new European
medicines legislation before their mandatory introduction are being sought by the Medicines and Healthcare products Regulatory Agency.
The MHRA wants to implement early a provision to encourage POM-to-P switching
of medicines. It also wants early implementation of a requirement to
test patient information leaflets (PILs) and any proposed changes to
them on users and to strengthen the requirement for medicines manufacturers
to tell the MHRA about new information that impacts on a medicine’s
benefits and risks.
The MHRA says that these changes offer public health benefits and that
by implementing them early the UK will be leading the way in Europe.
There will be separate consultation on implementing the remaining changes
required by Europe by the end of October 2005.
To encourage POM-to-P switching, companies that justify their reclassification
applications with new test or trial results will get a year’s data
protection for their results. Currently, a first applicant’s marketing
advantage can be as little as 90 days. The MHRA wants to see this change
implemented in January 2005.
John Blenkinsopp, a POM-to-P switching consultant, said that the next
three years would see a sea-change with respect to switching that will
mean that pharmacists have to be out of their dispensaries and dealing
with customers. There were four switch applications with the MHRA now
and a further 11 on the cards. “The Government wants pharmacists
in the front of house,” he said. “These are switches that
could not move on to GSL. The value of the pharmacist’s interaction
with patients cannot be usurped.”
Also in January 2005, the MHRA wants to introduce a new requirement for
companies to tell it about any new information
that might affect a marketing authorisation. This would include the results
of any post-authorisation safety studies or clinical trials.
The third change to be implemented early — user testing of PILs — will
not take place until April 2005. User testing is intended to ensure that
patient information is clear and well understood.
David Pruce, director of practice and quality improvement for the Royal
Pharmaceutical Society, said: “We support any proposals that would
lead to improvements in the clarity and readability of PILs.”
On the proposal in relation to new information, Mr Pruce said: “These
proposals aim to provide further safeguards and increase patient safety
and this is welcome.” |
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