Health and Sport Committee
Meeting date: Tuesday, April 17, 2012
Official Report
490KB pdf
European Union Legislative Proposal
Agenda item 4 is consideration of the European Union legislative proposal to amend the directive relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems. The proposal may raise questions in relation to subsidiarity.
As Richard Lyle is the committee’s European reporter, I ask him to comment on the proposal.
All members have the cover note. The transparency directive was originally adopted in 1989. The UK Department of Health has the lead responsibility on the matter, but the Scottish Government holds an interest in relation to its responsibilities for public health and healthcare provision. The revised directive will be legally binding on the UK.
The transparency directive sets procedural requirements to enable the pharmaceutical industry to verify that national measures do not create barriers to trade that are incompatible with the free movement of goods. On 1 March 2012, in light of changes to the regulatory framework for medicines and changes in the approaches of member states to the pricing of medicines, the European Commission published proposals to update and simplify those procedural requirements. The aim is primarily to streamline the process and to reduce the time that it takes for national decisions to be made on pricing and reimbursement of medicines so that such decisions are, as a rule, taken within 120 days for innovative medicines and within 30 rather than 180 days—as is currently the case—for generic medicinal products.
The salient points to note are that detailed discussions are expected to begin at a meeting of the Council working group on pharmaceutical and medical devices that is scheduled to be held this week, on 20 April 2012, and that the presidency will consider a revised directive on 22 June 2012.
The committee has two choices. It can note what I have said and decide to take no further action. Alternatively, it can monitor the progress of the proposal in the longer term and write to the Scottish Government to ascertain its position on the matter and to find out the anticipated impact, if any, on the quality of healthcare and the costs to the NHS in Scotland; what discussions the Scottish Government has had with the Department of Health concerning the proposal and the nature of any such discussions; and whether it shares the view of the UK Government that
“the consistency of the Commission’s proposal with the principle of subsidiarity has yet to be examined”.
It is for the committee to make that decision.
Thanks. Do members have any comments?
I have just one comment. There have been discussions in the UK for some considerable time about moving from the long-established pharmaceutical price regulation scheme system to a value-based system. From reading the documents that we have before us, that seems to be quite important to when the directive might be enacted, so I suggest that we should go for the second option rather than the first one. We should also do so because of another matter that is peculiar to the current situation, which is the highly significant and unresolved issue of export. I do not know how relevant that is to the Commission proposal; Richard Lyle may know about that.
There is a continuing problem of restriction of supply by the pharmaceutical industry to reduce the likelihood of export by pharmacists, a number of whom still export. The result is that some of my constituents face considerable anxiety about the supply of their prescription medicine. The Royal Pharmaceutical Society, the community pharmacists and the pharmaceutical industry appear to have been unable to resolve the issue amicably between them in a way that protects patients. I find that very disturbing.
I do not know—and I cannot work out from reading the cover note—whether the new transparency directive, which relates to the export or transfer of goods, will make the situation better or worse. That is another reason why I would like the second option to be followed.
I agree with Dr Richard Simpson’s comments. In order to alleviate his constituents’ concerns, we may wish to put the issues that he has raised to the Scottish Government, which in turn could contact the UK Government.
Is everyone content with that approach?
Members indicated agreement.
We will go for the second option then. Thank you.