Clinically dead?
The economic crisis and EU red tape have led to a sharp drop in the number of clinical trials in the EU
Over the past decade, Europe’s pharmaceutical industry has faced a serious problem – a decline in the output from research being conducted. The reasons are myriad, including a lack of confidence in investment and austerity-driven budget cuts. But what inhibits researchers most, they say, is cumbersome EU regulation.
In 2001, when the EU passed the clinical trials directive, the aim was to harmonise the way in which drug trials are conducted to facilitate more information-sharing and avoid duplication. But, according to researchers, the requirements that have been in place since 2004 have resulted in a bureaucratic tangle that has slowed down the pace of research. Even small-scale clinical trials can require huge amounts of documentation.
The European Commission acknowledges that the problem exists and is trying to do something about it. “It is too complex when it is a multi-national trial, an assessment is repeated in each member state,” said Paola Testori, director-general of the Commission’s health department. “It has a negative impact not only on the pharmaceutical industry but also on patients.” The Commission estimates that the directive contributed to a 25% decrease in the number of clinical trials between 2007 and 2011. The number of clinical trials in Europe each year is now less than half that conducted in the United States.
Last year the Commission put forward a proposal to revise the directive and simplify the authorisation procedure by requiring only one application per clinical trial – although this would still be subject to approval by each member state concerned. The proposal would also give the Commission the right to check that the rules are being properly applied.
The European pharmaceutical industry has welcomed the proposal, but it is concerned that it may be watered down by the member states and overburdened with transparency requirements by the European Parliament.
The proposal would allow member states to opt out of the ‘single EU submission’ for some sensitive issues such as stem-cell research. But several member states want this opt-out to be much wider, covering areas such as medications that are used by ‘vulnerable’ people. “That is something we are concerned about, [that] it would fragment the assessment,” said Gabriella Almberg, head of government affairs for the European Federation of Pharmaceutical Industries and Associations (EFPIA). “There is no proper definition of what is a vulnerable person…it could be almost everyone.”
Almberg said the industry is also worried about moves by Glenis Willmott, a centre-left British MEP who is guiding the legislation through the Parliament, to expand the directive’s transparency requirements. The Commission’s proposal requires that clinical trial results are made public and seeks to make it easier to tell whether a trial is ongoing. It would set up a ‘transparency database’ where companies would have to publish summaries of their clinical study reports one year after they are conducted. But Willmott wants to see the full reports published. “A simple summary has the potential to be biased and misleading,” she said.
Almberg said such a requirement could risk the disclosure of commercially sensitive information before a company has had a chance to market its drug. “We would be concerned about having to publish that before we have the medicine on the market,” she said. “We also question the value – patients don’t have an interest in this when the medicine is not available to them anyway.”
The issue has become one of the most contentious in the revision of the directive, and Willmott held a special hearing on the issue yesterday (10 April). Health campaigners say the revision should put questions of transparency and patient safety ahead of commercial concerns.
One aspect of the Commission’s proposal that has concerned both the pharmaceutical industry and health campaigners is its failure to set out a framework for ‘ethics committees’ in member states, which look at patients’ rights issues in clinical trials, such as informed consent. There have long been complaints that the 2001 directive allowed member states to operate these bodies in widely divergent ways, and the 1,800 ethics committees active in Europe do not systematically communicate.
The Commission proposal has created alarm because it does not specify that the analysis of ethics should be carried out at national level. MEPs want to make clear that ethics is a national competence. The Parliament’s environment committe will vote on the proposal next month.
Financial concerns
The slowing down of clinical trial activity in Europe cannot be blamed entirely on the EU directive. The economic crisis plays a part too. Member states are trying to constrain spending on national health services as part of general austerity drives, and industry complains of a reduction in incentives for investment in research and innovation.
Measures adopted have included increased VAT on medicines and strict new pricing environments. Spain has lowered the price of generic medicines by 30%, while the UK has cut 1.9% off branded National Health Service medicines. Germany has introduced a price freeze on reimbursable medicines.
All of this, combined with the general economic downturn, has made pharmaceutical companies increasingly cautious about investing in long-term research. Even if a revision of the EU’s clinical trials rules reduces administrative burdens, economic conditions could still hold down research budgets.