An innovative approach

On 11 December 2007, the European parliament adopted the report on the creation of a joint European technology initiative for innovative medicines, for which I was the rapporteur. The innovative medicines initiative (IMI) is a major  step forward to encouraging large-scale research programmes and is a clear break with the traditional approach of public financing of European programmes by embracing the public-private partnership method. PPPs are redefining the traditional frontiers between those who produce, develop and commercialise the results of research projects. Knowledge creation thus becomes a collective activity, where universities and other academic establishments no longer have the monopoly on scientific production but instead work hand-in-hand with business.

The European commission needs to look at the needs of European researchers from a different angle. The EU is the world leader in many research fields, but it is facing a growing number of challenges not only from traditional competitors such as the US or Japan but also from emerging markets such as India or China. The EU sometimes appears to fall foul of paradoxes that stop it from fulfilling its potential. For example, it has proved extremely hard to convert the fruits of European innovation into new products, patents or jobs, while many small and medium-sized enterprises (SMEs) find it hard to grow and succeed on the wider international stage. In particular, the productivity of European research and development (R&D) in the pharmaceutical sector has been in free fall for the last 30 years, despite a constant increase in financial investment in R&D.

Over the last 25 years, R&D spending per medicine launched on the market has risen from €54m to €880m – an average annual increase of 11.8 per cent. At the same time, the length of time it takes before new medicines become profitable has significantly increased: from 2.5 years in the 1960s to 6.5 years in the 1990s. Moreover, the failure rates of new medicines have also increased: increasingly large numbers of molecules have to be tested in order to find just one that could eventually prove viable.

The IMI will finance pan-European PPPs focusing on biomedical research, and has already been warmly welcomed by many SMEs working in the field of biotechnology. SMEs are key drivers of the European economy, and have many strengths – but they also have a number of weaknesses, including getting access to sufficient funding and managing their often meagre resources. The IMI is an initiative created jointly by the European commission and the European federation of pharmaceutical industries and associations (EFPIA) and is unique in that it brings together public authorities, patients, universities, hospitals and representatives from the pharmaceutical industry around the same table.

The IMI has a total budget of €2bn for 2008-2013, a not insignificant amount. The contribution of €1bn from the European commission will go directly to SMEs and universities, while bigger companies will contribute their own funds to the initiative, which will also help the SMEs and universities by providing them with the tools to assess the safety and efficacy of medicines, as well as giving them access to better research infrastructure and knowledge.

IMI will also help support the development of new areas of expertise, new research tools and new methodologies in order to ensure that safer, better targeted medicines are brought more rapidly on to the market. This in turn will bring better healthcare for patients, especially those with cancer or neurological, inflammatory, metabolic or infectious problems.

It is important to remember that the aim of the IMI is not to produce specific treatments but to identify the ‘bottlenecks’ in the R&D process, such as safety procedure, the effectiveness of medicines, knowledge handling and teaching and training. Progress in these four key areas would allow researchers to discover and develop new and better medicines more quickly – in particular for ailments that are currently neglected. The collective approach of the PPP will mean that there is less risk for SMEs and should help them to develop new products more rapidly, thanks to the shared infrastructure, resources and equipment. For the first time, the IMI will bring together the expertise and skills of SMEs, particularly those in the biotech arena, with those of research institutes, major pharmaceutical companies, patients’ associations and regulatory authorities.

The initiative will be coordinated by a secretariat that will be financed and run jointly by the commission and EFPIA. The first calls for tender were published on 30 April. Public research institutes and SMEs will have until 15 July to form consortia and reply to the tender, which is focusing on neurodegenerative, metabolic and inflammatory diseases. The research programmes considered to be the most promising will receive funding of €123m in total for 2008, excluding further investments from the major pharmaceutical companies, which should be around €170bn.

Some critics are concerned that this is an overly complicated way of going about supporting medical research, but in reality it will make it easier for everyone involved to work more effectively and to reduce the risks inherent in the development of medicines. From 1 July to 31 December 2008, France will hold the rotating EU presidency, and I believe that it is important for France to encourage any kind of initiative that works along the same lines as the IMI. It is thanks to this kind of initiative that we will, perhaps, one day find a means of treating diseases such as Alzheimer’s, one of the health priorities of the French presidency.

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