eMedCareers

‘Do Clinical Trials Have a Future in the UK? The Big Debate’

As a member of the ICR Special Interest Group I am pleased to announce a “Question Time” style debate we are hosting entitled ‘Do Clinical Trials Have a Future in the UK?’

This event will take place on Thursday 16^th September (from 2pm until 5pm) at the Joint Clinical Trials Unit at Guy’s and St. Thomas’ Hospital, London.

The debate is one not to be missed and is open to all members of the ICR and the wider Clinical Research community.

In a previous Pipeline blog post I stated:

Approximately 6% of the world’s clinical trials used to be conducted within the UK.  That figure has dropped dramatically and the commonly held view is that clinical trials run from the UK is they are too expensive, take too long to run and it is difficult to recruit patients.  With the emergence of India, China and other emerging markets the UK will never capture the market share it once had.  However, it is my own view that with the correct support and collaboration between Government, NICE, the ABPI, the Networks and the ICR that the UK can become competitive within Europe again.

This exciting event provides a unique opportunity to hear leading members of the drug development community lock horns over controversial questions put to them by a participating audience regarding the future of clinical trials in the UK.

Confirmed panellists include:

• Jane Bentley – Project Management Operations, Oncology Clinical Research
• Joanne Clarke – Clinical Studies Unit Director, Sanofi-aventis
• Alison Jeynes-Ellis – Medical and Innovation Director, ABPI
• Dennis Joseph – Area Head, Clinical Operations Europe, Pfizer
• Clare Morgan – Director for Industry, NIHR CRN
• Maria Palmer – Director of the UK NHS R&D Forum
• Carol Parish – Director of Clinical Development/Head of EU in Emerging Markets, Stiefel
• Jackie Powell – Director, Joint Clinical Trials Office, Guy’s Hospital
• Paul Wathall – Acting CEO for the ICR
• Kaye Hallett – Senior Director Clinical Operations from Quintiles

To gain Free Admission please pre-register, please visit www.icr-global.org, call + 44 1628 536960 or email Dean Powles dpowles@icr-global.org

European drug prices to be slashed stifling the development of new medicines and resulting in thousands of job losses.

Drug companies are expecting further price reductions to be enforced across Europe in the next 18 months.

European governments have started to introduce austerity measures in a trend that looks likely to continue in to 2011.

Greece

The most drastic austerity measures of any European country but this could have consequences across the region considering the affects of reference pricing and parallel imports.  Drug prices have been cut between 20-27%.

I previously mentioned the situation in Greece in an earlier blog entry

Germany

Pharmaceutical companies have historically been able to set their own prices in German leading to some of the highest across Europe.  The German government has proposed legislation to force drug prices based on a set cost-effectiveness criteria.

A price cap for patented drugs has also been introduced.  These measures aim to reduce prices potentially save the German healthcare system around 2 billion euros a year.

Germany is the third largest drug market and as it is a reference market for drug prices in many European Union (EU) member states this could lead to price reductions across Europe

Italy

The price of off-patent generic drugs has been cut by 12.5% for the remainder of the year.  In 2011 tenders will be introduced with the health system only allowed to buy products at the cheapest bid.  The measures could amount to savings of 600 million euros ($733.8 million)

Spain

The government has announced plans to cut the prices of patented prescription drugs by up to 23%.  This could equate to savings of roughly 1.3 billion euros ($1.6 billion).  The price paid by the government for generics has also been reduced by 25%.

France

The French public health insurer CNAMTS (Caisse Nationale d’Assurance-Maladie des Travailleurs Salaries) has recommended 21 cost-containment measures aimed at bringing savings of 2.2 billion euros ($2.77 billion) and limiting health care spending growth to 2.9% in 2011.

A study conducted by European School of Management and Technology (ESMT) concludes:

‘Cutting pharmaceutical prices will severely reduce the number of new medications making it to market.’

The study on ‘Pharmaceutical Innovation and Pricing Regulation’ identifies a direct link between strict regulation and low innovation.

Dr. Hans W. Friederiszick of ESMT CA quotes:

‘Our study shows the consequences that pricing and reimbursement regulation can have on pharmaceutical innovation. It also shows that, incorrectly applied, regulation can reduce the value of pharmaceutical projects and curtail the resources available to carry them out. Rational investors will naturally look for the most profitable investment choices, which is why regulation has a direct impact on the number and characteristics of the medications developed.’

The forced reduction in prices caused by imposed austerity measures by Governments across Europe is going to lower the return on investment.  We have already seen Big Pharma companies ‘pull out’ of R&D in some disease areas as their margins have been further squeezed and this is likely to continue.  http://www.emedcareers.com/pipeline/2010/03/03/depressing-news/

The result has been closure of research sites causing mass redundancies and less clinical trial being conducted.  Although there are a significant number or phase III trials current being conducted the lack of early phase trials entering the system is worrying.  We have certainly seen a reduction in the number of roles in Clinical Research advertised on the site.

Over the past few years the number of GP Representatives within the UK has halved with a shift to specialist Key Account Manager (KAM) role selling to local health managers within the 152 PCTs.

Andrew Lansley’s White Paper Equity and Excellence: Liberating the NHS released yesterday will turn this on its head and hand commissioning power back to GPs, in a similar system to the general practitioner fund-holding scheme introduced by the conservative Major government in 1991.
The Government proposals look to hand 80 per cent of the £105 billion NHS budget to consortia of GPs with an independent NHS commissioning board allocating budgets to these consortia.
Centre-right think tank Civitas states that there is little evidence suggesting GPs will be more effective at commissioning than PCTs.  In its report Civitas suggests that the plans could well lead to a dip in NHS performance and wipe out any chance of achieving the £20bn efficiency savings target.

GPs themselves seem to have mixed views regarding the proposals.  Whilst many believe this presents an opportunity for clinicians to lead from the front and make a real difference to their patients’ health it is also reported that many practices are not ready and the timeframe for implementation is extremely optimistic.

NHS Alliance press release

NAPC press release

In the white paper PCTs and SHAs will be scrapped and GPs will have full financial responsibility from April 2013.  So over the next couple of years are we  about to see a re-emergence of the primary care representative and the number of these  jobs increase within the UK.