Code of Practice update to reflect legal changes
pharmafile | May 11, 2012 | News story | Medical Communications | ABPI, Code of Practice, MHRA, PMCPA, patient organisations
The UK pharma industry’s Code of Practice is set to be updated to bring it into line with changes in UK law and the international pharma code.
UK laws relating to medicines are currently being amended and consolidated in The Human Medicines Regulations 2012, which is expected to be made law in early July.
Meanwhile the international pharma industry organisation the IFPMA has also updated its Code of Practice, so the UK industry is now suggesting changes to reflect the developments.
The UK industry’s self-regulatory watchdog the PMCPA is suggesting 17 changes in all, and is now consulting on the changes.
While several amendments are relatively trivial, some changes could be significant – these include new clauses about pharma relations with patient organisations, and others banning the supply of ‘starter packs’.
Regarding relations with patient organisations, an existing clause about funding the groups is to be made stricter. The Code currently states: “No company may require that it be the sole funder of a patient organisation or any of its major programmes.”
The new Code would delete the word ‘major’ with the aim of strengthening guarantees of patient organisation independence.
A new sentence stating: “Companies must respect the independence of patient organisations” is also proposed, to reflect IFPMA changes.
Meanwhile in terms of the supply of free samples and other short-term supplies, the Department of Health says pharmaceutical companies should have ‘no role’ in providing such medicine supplies for use in emergency situations.
A new clause stating that “the provision of starter packs is not permitted” will therefore be added to the Code.
Another change is a clause recognising that companies are allowed to provide price lists for unlicensed medicines. This reflects a judgement by the European Court of Justice which said the practice is permissible as long as no product claims are made.
A second clause makes it clear that sending out unsolicited price lists for unlicensed medicines is not permitted.
The proposals have been sent to the MHRA, the British Medical Association (BMA), the Royal Pharmaceutical Society of Great Britain (RPSGB) and the Royal College of Nursing (RCN) as required by the Constitution and Procedure. They have also been sent to the Serious Fraud Office (SFO).
It is anticipated that final proposals will come before the ABPI Meeting on 11 June 2012 with a view to approval by member companies. If approved, the new Code of Practice would come into effect on 1 July 2012, but with a transitional period before becoming fully operative on 1 November 2012.
The proposals are the subject of public consultation and comments must be submitted to hsimmonds@pmcpa.org.uk as soon as possible, and by no later than Thursday 24 May.
Visit the MHRA site for more information on the The Human Medicines Regulations 2012.
Andrew McConaghie
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