EU Commission outlines pharmaceutical strategy
terms of innovation and R&D expenditure and is increasingly
under threat from newcomers, especially in India and China.
Although the European-based pharmaceutical/biotech industry is still a robust sector making a substantial positive contribution to the Union's trade balance, employment science base and public health it is declining in relative terms compared to the United States and growing challenges from India and the Far East.
One of the biggest barriers to responding to this challenge is that there is no single market in pharmaceuticals: national systems of pricing and reimbursement, assessments of cost/clinical effectiveness etc. vary enormously leading to an uncertain climate for investment and varying access times to the market.
In a speech at the European Federation of Pharmaceutical Industries and Association (EFPIA), Commission Vice-President, Günter Verheugen addressed these difficulties outlining elements of a new Commission industrial strategy for the pharmaceutical sector.
The strategy is intended to go beyond regulatory interventions by enhancing the environment for innovation and investment, reflecting on ways to give more market flexibility to industry and improving quality of information to patients and patient safety.
Verheugen said: "Europe must decide whether we want to continue to be a leading player in pharmaceutical innovation or whether we simply step aside and let others do the job. I have no intention of stepping aside."
"Not only is the pharmaceutical sector vital to our economy and science base but also it will be a key component in the enormous health challenges, which will dominate the political agenda for the foreseeable future," he added.
Verheugen added that but we need to see an equally strong commitment from industry to keeping Europe as a major centre for innovation. While in the late 1980s only 41 per cent of the top 50 innovative drugs were of American origin, in the late 1990s the US percentage climbed to 62 per cent. In 1992, six out of the ten top medicines in worldwide sales were European, while in 2002 this figure had fallen to just two.
During his speech, Verheugen focused on three areas of the proposed strategy. In boosting innovation and regaining the competitive advantage, he pointed out that long-term competitiveness of the pharmaceutical sector depended on support for its science base.
In particular, to take advantage of the new 7th Research Framework Programme (FP7) to support R&D projects that are relevant to the industry. To reiterate its commitment, the Commission proposed a new € 2.6 billion Entrepreneurship and Innovation Programme which will support SMEs and start-ups, a major feature of the European pharma-biotechnology sector.
Of particular importance will be the new Technology Platforms to foster public-private partnerships at the European level and bring together Academia, Industry, Member States and the Commission in order to pool limited resources to create added value.
The Commission also wants to look at ways in which they can be given more flexibility in establishing prices without compromising any capacity of Member States to protect their health care budgets. Verheugen recommended this reflection should look at the speed of access to the market, lifting of pricing controls for medicines that fall outside the state sector, parallel trade and the impact of the Transparency Directive.
Verheugen also focused on improving information and safety for patients in which the Commission intends to establish a public-private partnership to improve access to information on medicines for the public.
With the recent safety concerns, there is a need for a review of pharmaco-vigilance in Europe. The Commission proposed a public debate in which to consider options for improving the safe use of medicines at both the national and European level. A review of national and European pharmaco-vigilance has already been commissioned.
