As one of Europe’s top performing high-technology sectors, the innovative capacity of the pharmaceutical industry is crucial
to its future. In 2011, companies invested an estimated €27.5 billion in R&D in Europe, but despite this high contribution,
there is ongoing concern that regional innovation levels are dropping (1). The pharmaceutical industry has placed some of
the blame on additional regulatory hurdles that have been introduced, as well as the austerity measures favoured by governments
in response to the current economic environment. Other factors intrinsic to the way that R&D is conducted, however, are also
believed to have played a part.
There is widespread agreement that the former R&D approach, which was productive in the past, is no longer sufficient to meet
expected drug output targets and that there is a need for new thinking. Although they often target the pharmaceutical industry
with cost containment measures, European governments have realised that it is not in their interests to cripple companies’
ability to innovate. Between 1995 and 2005, there was a noticeable drift in pharmaceutical research activity towards the United
States, which was believed by many companies to offer a more conducive environment for research (1). Europe’s standing as
a location for innovative R&D is also challenged by competition from emerging economies. However, Europe is taking measures
to boost innovation. One of the region’s most significant efforts is through the Innovative Medicines Initiative (IMI), which
recently launched its eighth call for projects and allocated €242.7 million in funding.
The development of the Innovative Medicines Initiative
In late 2002, the G10 Medicines Group brought together top European industry and public health decision makers to develop
a strategy for improving Europe’s competitiveness in innovation. One important achievement was the establishment of a system
of EU indicators to enable comparisons to be made between the EU and its major competitors. The G10 Medicines Group subsequently
published a report on its findings for the European Commission, outlining proposals for concrete action to be taken to boost
innovation (2). One of the conclusions from the report was that better cooperation between academic science and industrial
science, which frequently occurs in the US, would be beneficial to Europe.
Although not specifically identified in the report from the G10 Medicines Group, the thinking of an effective division of
labour between academic and commercial organisations was influential in the creation of the IMI, which was launched in May
2007. IMI’s stated objective was to reinvigorate the European biopharmaceutical sector by creating public–private collaboration
where competitors in the pharmaceutical sector work together with counterparts from academic research, as well as with regulatory
agencies and patient organisations. To date, IMI has funded projects in the areas of safety and efficacy, knowledge management,
and education and training following responses to its call for proposals. The European Commission’s Seventh Framework Programme
contributes €1 billion to the IMI research programme and this sum is also matched by member companies of the European Federation
of Pharmaceutical Industries and Associations (EFPIA).
Does IMI work?
As a joint undertaking between the European Union (EU) and EFPIA, the IMI has the backing of very powerful institutions, which
shows a genuine commitment to revitalising Europe’s research environment. From the outset, however, there have been concerns
about whether the IMI could operate in practice. In 2010, The League of European Research Universities (LERU) wrote a letter
to the IMI board to highlight what it perceived as deficiencies in the system (3,4). LERU’s key criticism was that the benefits
from collaboration were skewed in favour of commercial organisations and that a lack of reassurance was putting off top academic
organisations from participating in IMI. Concerns noted were that academics tended to be underfunded for their participation
and that IMI’s intellectual property policy was vague and favoured the industry. Academics also complained about the level
of bureaucracy when dealing with the management of pharmaceutical companies. Despite this criticism, IMI rejected LERU’s views,
stating that 155 universities and 24 SMEs had taken part in projects as part of the first call for proposals and so interest
in IMI could not be called into question.
In 2011, the first evaluation of IMI was conducted by a panel of independent experts. The panel based its findings on documents
and other published information, as well as interviews with a wide range of IMI stakeholders, participants of IMI-supported
research projects and representatives of regulatory bodies, patients organisations and research associations. This was then
followed be a performance evaluation, which involved a strengths, weaknesses, opportunities and threats analysis to develop
suitable recommendations (5). Overall, the panel appeared to have a positive impression of IMI. Although it was noted that
IMI was hampered by bureaucracy in its initial set-up, projects had been successfully launched and were continuing to be developed.
Interest in IMI has also been high. The first call for proposals led to 138 expressions of interest received for 18 topics
with 1294 participants from 36 countries and interest levels do not seem to have dropped during subsequent calls for proposals.
In general, the panel felt that the public–private collaborative model was sound. Nevertheless, flaws were identified that
the panel felt were taking too long to address. One of these was the intellectual property issue described by LERU in 2010.
Another area was communication, which was felt to be weak on several fronts. There was also concern that not enough was being
done to publicise IMI to attract a wider range of stakeholders and to provide interested parties with reasons as to why they
should consider participation. There were also worries that mixed messages were emanating from within IMI and that not all
parties involved in communication were sufficiently empowered.