ABPI

At last! A patient-centred statement on the proposed EU Clinical Trials Regulation

First, a brief history of time in the Europe Union (EU).

It goes slowly.

That’s it!

For the last two years or so the European Commission has been consulting on plans to revise the European Clinical Trials Directive.  The Directive has been in force since 2001.  Researchers hate it.  To be fair so do many patient organisations.   The main complaint is that it slows down research into new drugs particularly in swotty Britain where we tend to do everything by the book and then bind it in gold leaf.  That’s probably because of a) our schooling, b) we are brought up as subjects and, c) because of the same tendencies that make us enjoy queuing (select  from the above as you see fit).

Over the summer the Commission published a draft proposal for new legislation or ‘Regulation’  for consultation and it is being considered by the European Parliament.  Cue the usual confetti of responses from organisations and alliances of organisations stating what they do and don’t like.  My basic summation of these responses thus far is that they think it’s much better because they won’t need any more gold leaf.

Last Thursday, the European Public Health Alliance (EPHA) – an association of non-governmental organisations from across Europe – issued its own revised policy position.  It is to be applauded for being the only one I have seen this far which pushes the Commission hard to consider certain aspects of growing importance to patients in trials:  the right to clear information; openness and transparency, and public involvement in all aspects of clinical trials.  The following para taken from their website gives you a taster:

‘From this perspective it is also vital that clinical trials reflect the populations that are meant to benefit from them – for example women, older people and ethnic minorities – and that access to clinical trial data and reports is as open and transparent as possible, which implies full public disclosure in a central database to protect public health interests. Moreover, patients’ involvement in the process is essential; while this is foreseen in the present proposal, the extent to which patients will be able to influence the process still requires clarification.’

By contrast, this statement issued by UK commercial and non-commercial organisations could, and should, have taken a much stronger line on public involvement than it does.  Particularly given many of the signatories, a number of  whom I admire greatly and are highly supportive of the agenda.  But public involvement is only really mentioned in reference to the Regulation’s proposed panel for reviewing trials.  Such documents – jointly written and needing to be agreed by many – are often a difficult compromise.  But this one does leave the impression that research is the dominant force, spinning a golden thread of ‘we know best.’

The UK has often set the international standard for public involvement in health research.  So I hope this is not one of those examples of our country going to sleep on the job only to wake up and find that our European neighbours are way ahead of us.  As I say, time passes slowly in Europe but not when you are asleep.

About these ads

1 reply »

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s