Public-private partnerships like Europe's Innovative Medicines Initiative, the EU’s mechanism that promotes new treatment R&D, are crucial to the industry's future, according to Paul Stoffels, Chairman global R&D pharmaceuticals at Johnson & Johnson.

Speaking at a Dec. 3 conference at the Belgian Senate on improving health equality across Europe, Stoffels and other leaders, including EU health Commissioner John Dalli and GlaxoSmithKline PLC CEO Andrew Witty, stressed the key role of the EU, alongside industry, in assuring the future of European pharmaceutical innovation. The conference was hosted by the European Federation for Pharmaceutical Industries and Associations.

IMI's funding is set to expire in 2017 and there are as yet no concrete plans to update the €2 billion ($2.65 billion) budget – currently provided equally by the European Union and the pharmaceutical industry. Reasonably enough, IMI funding post-2017 is wholly dependent on the initiative's results to date. It's far too early for anything significant yet, though; the initiative only really got going at the end of 2007. But IMI Board Member and CEO of UCB SA, Roch Doliveux, is confident.

In June 2010, IMI presented its first fully functioning research projects across major illnesses including Alzheimer's, asthma, cardiovascular disease, chronic pain, depression, diabetes and schizophrenia.

Europe Ahead Of U.S In Public-Private Collaboration

Europe’s governments argue that IMI – set up in order to improve the R&D process by supporting a more efficient discovery and development of better and safer medicines – has placed the EU ahead of the U.S in terms of advancing pharmaceutical R&D. Certainly the EU has invested more in this type of cooperative project than the U.S. government, anyway. Moreover, the European Commission's support to companies, and its success in harnessing them to work alongside each other, sets Europe apart from the U.S, according to IMI Executive Director Michel Goldman. “Those in the U.S. are really wondering how we have succeeded in Europe to get all the stakeholders working together,” he claimed.

IMI has managed to link together a network of academic institutions, small and medium-sized enterprises, biopharmaceutical companies, regulatory authorities and patients, as well as governmental authority in the form of public-private partnerships. However, what is unique about the IMI as compared with other public-private partnerships is that each project involves a collaborative approach by seven to 20 private companies, a first for the European pharmaceutical sector.

These private-public collaborations are particularly important now because of waning interest from struggling venture capitalists, particularly in early-stage medicines discovery and development, said Stoffels. “Development of translational medicine [translating early science into clinical benefit], which has traditionally taken place in the biotechnology sector, is almost not happening anymore,” he noted.

While most pharmaceutical research globally is still funded privately – IMI is a deviation from this norm – the industry is regulated by governments.

As regulators, health technology assessment agencies (like NICE in the U.K.) and payers step up their requests for robust benefit/risk data from industry to prove the added value of their new drugs; the danger is that industry's investment in R&D will be greatly reduced, Stoffels said, adding that there is evidence that this is already happening today. Pfizer closed six of its 20 research facilities, including two in the U.K., after buying Wyeth, and published plans to cut 15% of its R&D staff. “You see massive mergers happening because big companies can’t survive anymore," Stoffels said, adding that the current environment, in his view, doesn't really support "a vibrant biotech/pharmaceutical industry for the future.”

It is against this backdrop that public-private partnerships like IMI have to be encouraged, Stoffels continued. However, they will only be successful when there's real cooperation between governments and industry umbrella groups on the one hand, and manufacturers themselves on the other, said Goldman. “I think that, to establish this kind of collaborative approach, which is so badly needed, Europe probably has an advantage [over the U.S.] in that it is multicultural. We are therefore used to people with different visions working together,” he concluded.

Europe can't exactly boast a spotless track record when it comes to different governments working together, but Goldman may nevertheless have a point. Still, as Stoffels stressed, it doesn't actually matter who is leading the field in terms of public-private partnership support for R&D innovation. “What is important is that we both [the U.S. and the EU] invest in it,” he said. In theory, in a global setting, both sides would benefit from each other’s commitment to these activities.

Who Owns What?

With such a large number of pharmaceutical companies and academic institutions involved in IMI, the issue of allocating intellectual property rights (IPR) is somewhat complex. Clearly defining and allocating those rights from the outset was a key priority for IMI's architects. There are three types of IPR: "background IPR," which refers to data and know-how held by a participant prior to entering the collaboration; "foreground IPR," which comprises results (including data, know-how and information) generated during the project within that project's remit; and "sideground IPR," meaning data generated by a participant during the project, but outside of the project's specific objectives.

Each participant remains the exclusive owner of its background IP but is free to license, assign or otherwise dispose of these rights. Foreground IP belongs to the participant(s) who generated it. This may give rise to joint ownership. In such a case, unless otherwise agreed in the Project Agreement, each joint owner may use this IP, including the right to grant non-exclusive licenses, provided the owner gives prior notice to any other joint owners and offers "fair and reasonable" compensation. Sideground IP belongs to the participant(s) who generated it

Project participants agree from the outset neither to disclose nor use confidential information received from others. However, participants may use, exploit, sublicense or otherwise commercialize their IPR as they see fit beyond the research use rights described in the IPR Policy. Where a participant seeks to exploit foreground IPR, its use will be negotiated between the parties involved.

The rules are clear, but as with any project involving multiple parties, there is room for disagreement. Although there are no problems to date arising from IPR issues, they may arise in the future as projects are completed. Still, against a backdrop of increasing collaboration and partnership across the industry more broadly, the hope is that IPR will not block progress.

A European Solution

Public-private partnerships are by no means a new development across Europe in the pharmaceutical sector. For example, in the German federal state of Lower Saxony, the government has established a network of academic institutions and pharmaceutical companies to focus on improving innovation, the economy and the region’s international competitiveness.

Last year the French government joined with industry to set up the €139 million InnoBio fund, aimed at supporting domestic biotech SMEs. In Belgium, the LRM fund was born out of a regional government regeneration initiative in the northeastern area of Limburg. Although its focus extends beyond the life sciences, it has invested in seven biopharma companies to date and typically takes a stake of up to €5 million over the life of the investment (usually five to 10 years).

The EU and its member states have begun to understand that the future of the pharmaceutical and biotechnology markets depends on government and industry co-operation. While such collaborations exist in the shadow of ever-tougher government cost-control measures, the fact that they exist at all, both on a national and regional level, offers hope that innovation will be safeguarded across the continent for the future.

By Faraz Kermani

Public-Private Partnerships Like IMI Crucial to Industry's Future, Argue Leaders

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