Policy: Task Masters - Pharmaceutical Executive

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Policy: Task Masters


Pharmaceutical Executive

London-Government and industry have agreed there should be no weakening of patent protection in the effort to speed access to medicines in the developing world.

Following a year-long competitiveness study, a joint government–industry task force concluded that intellectual property protection is not in itself a barrier to access and that weakening it would be counterproductive.

Prime minister Tony Blair set up the task force in March 2000 after industry leaders expressed concern that the changing environment-particularly the establishment of the National Institute of Clinical Excellence (NICE)-was blunting its competitiveness. The Pharmaceutical Industry Competitiveness Task Force (PICTF)-co-chaired by Lord Hunt, government health minister, and Tom McKillop, chief executive of AstraZeneca-agreed on several measures to promote industry.

In addition to taking a forthright stance on patent protection. PICTF agreed that industry’s concerns about NICE’s policies should be examined in detail. Through NICE, the United Kingdom alone is using cost-effectiveness data at a national level to influence prescribing. Elsewhere in Europe, it is used only to determine reimbursement levels. Industry fears the agency reaches its decisions prematurely, affecting the National Health Service’s (NHS) use of new medicines.

With the controversy over whether to allow Viagra (sildenafil) prescriptions on NHS’ list of approved medications still fresh in its members’ memories, PICTF agreed that not all medicines coming to market would be appropriate for NHS use. The industry is therefore calling for arrangements to allow NHS prescribers using NHS facilities to issue private prescriptions of such medicines as well as to speed up the switch from prescription-only to pharmacy availability.

On the EU level, PICTF believes economies, industry, and patients will benefit from advancing the single market, but it calls for a gradualist approach: removing OTC and nonreimbursed medicine price controls and easing the sale of medicines in the private sector. The task force also wants changes in presubmission dialogue, among other improvements, to bring about "more predictable regulatory decision making, globally competitive approval times, and the possibility of more rapid availability of innovative medicines to European patients."

One subject on which industry and government failed to agree is the prohibition of DTC advertising. Both parties are examining how companies might be able to provide more information about medicines. The ban on DTC advertising is "unsustainable" in the long term, industry maintains, and changes in legislation are needed to deliver a "truly rational package and bring accurate information" to the public.

PICTF’s report comes as the UK pharma industry reports profits in of ?2.3 billion, prompting some to ask whether its competitiveness is really in danger of being eroded. On the other hand, Dr. Trevor Jones, director-general of the Association of the British Pharmaceutical Industry (ABPI), claims that several Japanese companies, which were thinking of investing in the United Kingdom, are now reconsidering because of British animal-rights protests.

PICTF has agreed that licensing procedures should be streamlined so resources currently devoted to administration can be reassigned to "promoting and supporting animal welfare," but it hasn’t provided any details. And amendments to UK criminal law clamping down on protesters might help reassure potential investors.

It is hardly surprising that a mood of self-congratulation prevails. PICTF declares it has produced an "impressive number of important outputs," a reply trumped only by Tony Blair, who professed himself "delighted" with its outcome. Whether the conclusions would have been the same had PICTF included prescribers or patient representatives rather than being what one newspaper called a "love-in" between government and industry remains a moot point.

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