CRA report is optimistic

10 January 2005 00:01  [Source: ICB]

The decline in the number of new drugs approved in the EU and US between 1999 and 2003 does not represent a continuing trend, according to a recent report by Charles River Associates (CRA), commissioned by the Enterprise Directorate of the European Commission. ‘Based on our analysis’, says CRA, ‘the very low level of authorisations in 2002 and 2003 were unusual...Without any targeted regulatory remedies we would expect the number of new active substances to return to the level seen over the last 10 years.’

The report, commissioned at the start of 2004, was prompted by the decline of approvals for new active substances, which fell from 27 to 17 in the EU from 1999 to 2003. There was also a decline in the number of marketing applications for new active substances, which fell from close to 40 in 2000 and 2001 to 25 in 2002 and 34 in 2003. In the US, approvals fell from 35 to 21 over the same period.

CRA also found little evidence supporting the accusation that the industry is focusing only on blockbuster drugs or ‘me-too’ products. But it did find that the US is developing more biologics drugs than Europe and that there is a clear global trend of increasing R&D expenditure over the past decade. ‘The “crisis”, therefore, is that the number of new products has not increased whilst the overall level of resources being invested has risen dramatically.’

Once it became apparent the fall-off in new drug approvals was not structural, the CRA report focused more on the medium term issues, says Tim Wilsdon, one of the authors.

CRA recommends a number of actions to stimulate the innovation of new drugs and overcome the long-term reduction in productivity. The main two, it says, are to clear the bottlenecks in Phase III development, and to improve Europe’s attractiveness as a location for innovative activity in the medium term.

After these, it has additional recommendations, including:

- fundamental changes to the reimbursement system;

- vigilance over the competitive effects of mergers;

- close consideration of the incentive impact of therapeutic reference pricing;

- development of a common methodology in the EU for assessment of relative clinical and cost effectiveness; and

- improved access to venture capital funding in the EU.

The CRA report will be put out for discussion by the Commission, ready for consideration in the Spring as part of the drive by the Luxembourg and UK presidencies of the Commission in 2005 to ‘improve the state of the competitiveness of the pharmaceutical industry’ in the EU.

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