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Self-replicating drugs committees are a 'virus' that need to be treated

A 'no entry' signPeople used to say "What is EMIG?", whereas now they are asking what EMIG's position is on the big issues facing the pharmaceutical industry. For those unfamiliar, the Ethical Medicines Industry Group (EMIG) is an association of more than 80 member companies focusing on the myriad political, business and regulatory issues affecting our members.

Eighty per cent of members are small to medium-sized enterprises (SME); some, at £100m+, are way outside the SME category and about ten per cent are biotechs. This enables EMIG to have a unique perspective on doing business in the UK.

When setting our 2010 strategy, we surveyed our members and, while generic substitution, over- and under-delivery of the Pharmaceutical Price Regulation Scheme and performance of the Medicines and Healthcare products Regulatory Agency were big issues, one stood out  a mile – market access. While some people may consider market access to be the preserve of the big players, it is an even more critical issue for SMEs.

The process of decentralising decision-making in the NHS would seem to make sense. However, that process has taken on a life all of its own and has become a virus that has slowed, almost to a standstill, the flow of innovative new medicines to patients.

We have all seen the uptake graphs of new products post-launch that show European affiliates' growth racing ahead while it takes three to five years before the UK begins to show any impact.

If your product is selected for a health technology appraisal and is successful, it becomes subject to NICE guidance and attracts statutory funding. If it is unsuccessful, it may take the Patient Access Scheme route and may therefore be funded.

Consequently, as the portion of the drug budget attracting statutory funding for those select newer products gets bigger, the portion that pays for all the existing drugs and newer 'smaller' drugs, gets smaller. Products which fall under NICE guidelines, even when 'endorsed' by guidelines, may be blocked by primary care organisations on cost.

Here is where the virus begins to work:
• At national level, we have NICE, All Wales Medicines Strategy Group, Scottish Medicines Consortium and N Ireland
• At 'subnational' level, we have the London New Drugs Group, the Midlands Therapeutics Review and Advisory Committee, the North East Treatment Advisory Group
• The primary care trusts themselves that hold the medicines budget and have their own formulary groups
• Every hospital has its own drug and therapeutics committee and now priority-setting groups are springing up
• There are practice-based commissioning formularies, area prescribing committees and mental health trusts.

These are examples of hurdles at every level and there are even more groups assessing, duplicating and adding unnecessary time and cost to getting medicines to those who need them.

It's certainly one way of increasing employment and keeping the medicines bill at bay. However, is that the role of the NHS? It has been said that if every hurdle was removed and doctors (what happened to them?) could prescribe as they were actually trained to do, then we would have change left over.

The reality is that assessment groups will not go away and they shouldn't. But there needs to be a balance and a serious assessment of what is being achieved and at what cost.

EMIG has set up a Market Access Group to identify how to work more closely with Government and the NHS to improve the access to medicines by patients by reducing the number and the cost of barriers and thereby incentivise companies to invest in innovations that are so needed.

If you want to know more, contact Leslie Galloway at

Leslie Galloway


The Author
Leslie Galloway is chairman of the Ethical Medicines Industry Group (EMIG)

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24th February 2010


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