EU Commissioner Raises Hopes For 'Leukaemia Busters' Exemption

9.00.00am UTC (GMT +0000) Tue 21st Oct 2003

A top European Commissioner has raised hopes that the work of local charity Leukaemia Busters may be able to continue unaffected by new EU restrictions on clinical trials.

Commissioner Erkki Liikanen says in a letter to Hampshire MEP Chris Huhne, who raised the issue on behalf of Leukaemia Busters, that he is 'confident that some of the concerns would be properly addressed' during preparation of guidelines on the directive.

The problem arises because the directive states that there should be only one sponsor for clinical trials, whereas charities like Leukaemia Busters often club together with universities and others to fund non-commercial research and trials. The EU procedures are aimed at big pharmaceutical companies, and are overly bureaucratic and costly, said Mr Huhne.

'This is a real problem for research into conditions like Leukaemia that affect relatively few, because the big drug companies are not interested. Research is up to charities and academics who must not face new obstacles' said Mr Huhne.

Commissioner Liikanen, however, assures Mr Huhne: 'Your concerns regarding potential hurdles to research have been taken on board and were discussed during a Pharmaceutical committee meeting'. He says that it is clearly not the intention of the Commission that the implementation of the clinical trials directive in national law should have a prohibitive effect on prospects for european research.

'On the contrary' Mr Liikanen says, 'it is the intention of the Commission to strengthen a European clinical trials environment in the interests of the European Research Area and the European citizens'.

Mr Huhne said that Mr Liikanen's letter was encouraging as far as it goes, but he will not rest until the Commission has clearly exempted charities like Leukaemia Busters or found another way around the provisions. Mr Huhne has tabled formal parliamentary questions to elicit a clear decision from the Commission.

'This issue is urgent because the UK Department of Health is putting the provisions of the EU directive into UK law, and will do so in the usual rigid Whitehall way unless they receive clear guidance to the contrary from the Commission' said Mr Huhne.