A new task force will examine European pharma’s competitiveness, innovation, and commitment to public health. The "G10" is not, as it may sound, an enlarged grouping of the world’s leading industrialized countries. It’s actually far more important than that.

G10 is the unofficial name for a committee of ten individuals established in March by the European Commission to improve pharmaceutical industry competitiveness and ensure its contribution to Europe’s healthcare goals. The group will meet three times within the next year and present a report to the commission no later than April 2002.

The committee was established following a meeting last year between Erkki Liikanen, European Union commissioner for enterprise and the information society, and David Byrne, EU commissioner for health and consumer protection. They examined a report claiming the European industry was falling behind its US counterpart, not because of R&D variations but because of greater demand for pharmaceuticals in the United States. One of the report’s proposals was further deregulation of the European market.

That report and the subsequent formation of G10 put the pharma industry back on Europe’s center stage. The tripartite discussions of the late 1990s, named the Bangemann Roundtables after the industry’s previous commissioner, tried to craft a sword that would cut through the Gordian knot of tension between the European Union’s commitment to a single market and member states’ insistence on retaining price controls.

But the sword wasn’t sharp enough. The initiative collapsed, and exhausted politicians, industry executives, and European Commission officials resigned themselves to simply hoping the problem would go away. The wholesale restructuring of the European Commission following its corruption scandals only deepened the vacuum.

Sharp Focus

The new process is intended to be very different. G10’s terms of reference pointedly state that it will be "time limited" and that only the ten team members will attend meetings. The Bangemann Roundtables were much larger and lengthier affairs.

The issues, on the other hand, are likely to be much the same. Whereas the Bangemann participants bravely sought to grapple with a seemingly insoluble situation-the creation of a single pharmaceutical market-the sleek G10 will review the extent to which current pharmaceutical, health, and enterprise policies achieve the twin goals of encouraging innovation and competitiveness and ensuring public health-at heart, similar issues.

At the group’s launch, Liikanen said he hoped the committee would be able to agree on policy approaches that won’t require the European Commission to take legislative action. He seemed to be saying that philosophy and radical action are out and pragmatism and incremental change are in.

The ten members of the team are

• Ulla Schmidt, German health minister
• ord Philip Hunt, British health minister
• Lars Rekke, Swedish minister for industry, employment, and communications
• Dr. Jose Miguel Boquinhas, Portuguese Secretary of State for health
• Angela Coulter, chief executive of the Picker Institute Europe
• Jean-Fran?ois Dehecq, president and CEO of Sanofi-Synth?labo and president of the European Federation of Pharmaceutical Industry Associations
• Andrew Kay, CEO of APS Berk and chairman of the European Generic Manufacturers Association
• Alessandro Banchi, board member of Boehringer Ingelheim and the Association of the European Self-Medication Industry
• Chris Viehbacher, chairman of Europe for GlaxoSmithKline Pharmaceuticals
• Ueli M?ller, president of the International Association of Mutualities.

With representatives from the OTC and generics industries on board, as well as Angela Coulter of the patient interest group Picker Institute Europe, it’s clear Big Pharma won’t have everything its own way. Picker Institute Europe is a registered charity with headquarters in Oxford, England, and branch offices in Germany, Sweden, and Switzerland. It is affiliated with the Institute of Health Sciences at the University of Oxford and is sister to the Boston-based Picker Institute, which has been developing and conducting patient-experience surveys since 1987.

Coulter says the industry is increasingly conscious of patients’ interests, but she anticipates hearing several differing views during the next year. There are no details yet about G10’s topics for discussion, but they are likely to be divided among the three broad areas of patient access, regulation, and innovation.

Public Pressure

Although the issue of access to drugs in developing countries has dominated the headlines recently, there are also concerns about whether the European Union’s various healthcare systems ensure equitable and cost-effective access to new products. Those concerns will only increase when the European Union expands to the east. Prospective eastern members are typically poorer, with different healthcare provisions, and are likely to resist forced attempts at privatization.

Access is already a major issue in the United Kingdom, where one task of the controversial National Institute for Clinical Excellence is to end postcode prescribing-regional variations in the use of medicines. Such variations also exist in other EU countries, and Coulter believes those without a NICE-type institute will eventually establish one.

On the subject of regulation, G10 is likely to return to some well worn themes. At such an early stage, it is difficult to gauge what their views will be concerning the free movement of pharmaceuticals through the European Union. But the European Commission has never favored an exemption for the pharma industry that would allow it to restrict parallel imports.

As the United States and developing countries move toward permitting parallel imports, it would be strange if the commission reversed its stance. There are no commission officials on G10, but any move to halt parallel imports would require legislation shaped by the commission, and Liikanen has already indicated he would prefer to avoid that route.

Another issue likely to come into the spotlight is the promotion of generics and OTC competition. In the past, Big Pharma has indicated that it would be willing to countenance the greater use of generics if that would free up resources for development of innovative therapies-what has been termed "headroom for innovation."

Intellectual property, the marketing authorization process, promotion of the science base, and public perceptions of biotechnology will be other key issues. In a separate but related move, the European Commission prepared information about biotechnology for the Stockholm European Council that took place in March.

Liikanen says biotech is widely recognized for providing the building blocks of some of the most promising technologies of the future. "But at the same time," he adds, "biotechnology requires a thorough debate on important ethical, environmental, and societal issues with all stakeholders involved to draw up a truly comprehensive policy in this field."

The commission believes the European biotech industry is still immature compared with that in the United States, although they have roughly the same number of companies. Many European companies are in their infancy, and the number of world-class players is low.

Philippe Busquin, commissioner for research, says, "Europe can be stronger in life sciences and biotechnology if we work together and if we create the right environment for research and innovation. We should fully exploit the potential these new technologies offer for our current and future well being, but in a responsible way and in a dialogue between scientists and citizens."