EU drug discovery crisis?

If the EU industry is to remain competitive it needs to respond to challenges from the US, warns the G10

In the past decade or so, there has been a relentless shift of pharmaceutical research away from Europe and towards the US. Europe is in danger of losing its importance as a centre for the discovery of new drugs, and it was concern over this that led to the European Commission setting up the so-called G10 group (despite the fact that it had 13 participants) to look at competitiveness in the pharmaceutical industry.

Led by two commissioners - enterprise commissioner Erkki Liikanen and health commissioner David Byrne the high level group was made up of representatives of government, industry and patient representatives. The mission was to look at three major areas provision of medicines to patients, the single market and regulation, and innovation. It was given the incredibly short time-scale of less than a year to come up with conclusions, and the 14 recommendations the group devised appeared in the report on innovation and provision of medicines that was launched in Brussels in May.

The first recommendation concerns benchmarking: the group quite rightly felt that it was all very well coming up with ideas, but if there was no way of measuring their success, there was little point in the exercise. So the Commission has been charged to develop a comprehensive set of indicators covering industry performance; the prevention and treatment of disease; the relationship between the various EU and member state regulatory structures; and the availability, access to and uptake of new drug products.

A particular concern is the length of time it can take for new medicines to become available to patients. There can be a delay of up to five years between the first European consumers having reimbursed access to a new medicine and the last. This is clearly a big disincentive to pharma companies, which have only a finite length of time to exploit their patents in the market to the full. The group has recommended that ways should be explored for improving the introduction of innovative medicines to the market, and speeding up reimbursement decisions.

generic versions

The group also expressed concern about the slow uptake of generic versions of patent-expired medicines. This is, on the whole, so slow that a large amount of money that could be spent by governments and health insurance companies on innovative new medicines is swallowed up by older medicines that could, given a healthy generics market, be much cheaper. So a competitive generic market should be encouraged, as it should have a positive effect on the market for innovative medicines. Similarly, a more successful non-prescription market should be encouraged by simplifying the reclassification process for prescription medicines and allowing the same trademark to be used for both versions.

A further point on pricing was that member states' authority to regulate prices should cover only medicines purchased or reimbursed by the state; full competition should be allowed for other medicines and those sold into private markets. Sharing of data and information between member states, particularly about clinical efficacy and cost-effectiveness, should also be improved to raise the quality, consistency and speed of reimbursement and pricing decisions across the EU.

Fundamental to the improved competitiveness of the European pharmaceutical industry is ensuring that innovation is stimulated and the EU science base improved. While investment in r&d has doubled within Europe in the past decade, in the same period the rise in the US has been five-fold. European companies are increasingly seeing the advantages of moving more of their research base to the US; Novartis, for example, has announced within the past couple of months that it is moving its research headquarters to the US.

The G10 group believes that one of the best ways of stimulating research would be to encourage much greater integration of research across national borders within the EU, as it is currently overly fragmented, with often only weak links between research centres in different member states, and similarly poor collaboration between public and privately funded research. G10 recommends the creation of European virtual institutes of health, connecting all existing centres of competence on fundamental and clinical research.

Research needs to be actively encouraged, too. Clinical trials, in particular, should be supported on a European scale, with a database of trials and clinical research results being established. Research incentives should be implemented, particularly for orphan and paediatric medicines.

improve competitiveness

Finally, the group is clear that the needs of the patient must not be forgotten in the rush to improve industry competitiveness. It felt that the current ban on direct-to-consumer advertising was correct for prescription medicines, but there should be no restrictions for non-prescription medicines. However, patients do need access to quality, understandable information about their medicines, and standards should be developed to ensure the quality of such information.

It also suggests that legislation relating to patient information leaflets should be reviewed, and the views of users canvassed alongside those of the regulators and the industry. The current requirements for content and order in leaflets can often lead to confusing information, and this is a particular problem for over-the-counter medicines where a health professional is much less likely to have given the patient advice.

Safety must also be paramount, and systems for post-marketing surveillance should be optimised to ensure co-ordinated processes are in place for gathering data on adverse events and patient safety. The group also recommends that the EC should consider providing core funding for patient groups to allow them to participate independently in the debate and decision-making on EU health matters.

The final recommendation anticipates the future enlargement of the EU, to ensure that there is a level playing field within the expanded EU. The enlargement is bound to have an impact on the industry, and rules regarding parallel imports, in particular, need to be considered.

Despite the widely differing backgrounds of the members of the group, they have managed to come up with a set of recommendations that look workable. If the European pharmaceutical industry is to thrive, then they need to be made to work, as otherwise increasing amounts of pharmaceutical research will head across the Atlantic, and without a strong science base, the European industry is likely to lose its competitive edge.