The fundamental ethos and creativity of cancer research is threatened by too much management and excessive regulation, says a Keynote Comment in The Lancet Oncology, January 2008 issue. The Comment also adds that there is a serious lack of regulation harmonization between countries.
Author Professor Richard Sullivan, London School of Economics and Political Science, London, UK and former Director of Clinical Programmes at Cancer Research UK, writes "For the past decade we have witnessed the inextricable rise of the business over-management of public-sector research and the layering of one set of regulations on another."
He explains that Europe is laden with various directives which have added complex and sometimes contradictory regulation to cancer research. Few lessons have been learnt, says Sullivan, and European regulatory policymaking carries on failing.
Sullivan argues that the member countries of the EU themselves are partly to blame. Their differing approaches to research governance and national legislation has resulted in a series of complex and diverse rules being applied to cancer research. An example is the varied regulation of the use of human tissues, which seriously impede the networking of tissue banks for cancer research between countries.
As funders, academic centers, and health care systems over-manage, individual European researchers have to spend enormous amounts of time and effort dealing with an ever-growing maze of rules and regulations.
The USA and Europe still have quite differing regulatory requirements for clinical trains. This lack of harmonization and of simplification of regulations seriously undermines transnational collaborative cancer research.
Cancer research should be subject to "Proportionate, fit-for-purpose regulations," Sullivan writes. "The research community must unite and engage with the regulatory policymakers directly, with the support of patient groups, to drive harmonization and deregulation".
An accompanying Leading Edge editorial draws attention to the numerous failures of the European Commission (EC) processes and calls for the consultation processes for EU directives to be improved.
The Lancet Oncology argues that the postponed implementation of the EU Physical Agents Electromagnetic Fields Directive 2004/40/EC from April 2008 until April 2012 is yet another example of the failure of the EC consultation process.
This directive was put forward to address public concern about the safety of telecommunications and aimed to limit the exposure of workers to risks of electromagnetic radiation, such as those working in the electricity, welding, and telecommunications industries, as well as people who work with MRI scanners. However, its implementation was delayed because of concerns about the lack of evidence on which the levels for recommended maximum exposure to electromagnetic fields for MRI workers were set.
The directive had adopted exposure limits that were based on internationally recognized 1998 guidelines. However, the limits were criticized as being based on biological effects that take place at doses that are not proven to have adverse health effects.
The evidence that was the basis for a set of 1998 guidelines should not have been used and added into the directive as absolute numbers, The Lancet Oncology argues. A report in June 2006 from the UK House of Commons Science and Technology Committee identified several problems with the consultation process: failings in the transmission of correctly weighted scientific information from experts in the UK and EC regulatory bodies; a heavy reliance on a single source of evidence; insufficient response by the regulators to the concerns of radiologists; and a slow response by the MRI community to realize the consequences of the directive for working practices.
The Lancet Oncology concludes: "If the mistakes of the past are not to be repeated, the consultation process for EU directives needs to be improved. Effective measures have to be put in place to ensure scientific evidence from the experts is translated, given appropriate weight, and transmitted and listened to by politicians in a more rational and pragmatic way," The Lancet Oncology concludes.
"The good, the bad, and the ugly: effect of regulations on cancer research"
Richard Sullivan
The Lancet Oncology Vol 9 January 2008
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