European Commission

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.

It has come to this.  The world’s top tennis players rush their shots to beat an 11pm curfew.  Bruce and Sir Paul are turned-off mid-performance.  And they don’t use real javelins in schools.

Looking across the the athletics field at my sons’ school sports day, I spied a clutch of children competing in the javelin.  Except this is not a javelin as I remember it.  It’s more like one of those foam beach toys.  But nowehere near as good.  In fact it’s probably more like throwing a giant, over-ripe banana.  I admire the optimism of a small boy as he lets fly.  I imagine his disappointment as it is carried sideways by the wind and belly-flops to the ground.  There is no point to the javelin I mused.

UK scientists who have long complained about the blunt and risk-averse nature of the current EU Clinical Trials Directive, will no doubt be pleased by the Commission’s announcement today to bring in a sharper legislative instrument.  The new ‘Regulation’ will mean lighter touch regulation for ‘low-risk’ clinical trials and a streamlining of the regulatory process across the EU.  This, married with the EU’s recent enthusiasm for making trial data publicly available, also looks like good news from a patient perspective. Nature coverage here.

Whether it stacks-up against the five ‘wishes’ that the European Patients Forum (EPF) expressed during the consultation about the existing Directive remains to be seen.  The Forum hoped that any revision of EU law would result in:

1. Ensuring meaningful patients’ involvement across all aspects of clinical trials;

2. Giving patients access to quality information regarding clinical trials;

3. Meaningful informed consent;

4. Transparency concerning the results of clinical trials;

5. Access to treatments after the end of clinical trials.

Faster, quicker, leaner trials, yes.  Rules that reflect patient choice, voice and experience, I fear not.

The Commission’s own web pages have a stack of information available about the new Regulation including a ‘Citizen Summary.’ That all other documents constantly refer to research ‘subjects’ betrays the fact that the full extent of the patient agenda is not quite part of their core philosophy.  Indeed. the summary is just that, it doesn’t really convince in explaining how citizen rights and interests have been reflected in the proposals.

When is science, or more particularly medical research, going to wake-up to the fact that the effectiveness of modern regulation and modern regulators hinges on a partnership between those being regulated and their consumers?  Perhaps closer to home we might have greater cause for optimism.  The new Health Research Authority (HRA) has just had its second public involvement workshop and is working through the options of what might be tangible outcomes of this work as part of its business plan.

Back in Brussels, I hate to say it, but it still feels like we are being given foam arrows.  And with none of the fun of the beach.

Enjoy your summer holidays.

If you are interested in the EU Directive on Information to Patients, known colloquially in La Grande Place as 2001/83/EC, then this article from InPharm which went online this afternoon will get you up to speed with the latest changes made by the European Commission.

The most significant of the three recent changes seems to be that health professionals who present information on drugs on behalf of pharma companies should declare what they have been paid and by whom.

I have not been following the Directive that closely I am afraid – I think the EU legislative process has been deliberately designed on the basis that people will lose the will after a certain length of time.  However, the underlying debate as it has travelled through its various stages has been how to ensure the EU does not go the ‘direct-to-consumer’ route as seen in the US.

I mentioned yesterday about the EU Commission’s plans to radically overhaul its approach to funding research and innovation.  As expected these were launched in the form of a green paper today which is now open for public consultation until 20 May 2011.  Quick summary as follows ( eGov also has quite a good overview).  The aim is for:

– Greater coherence in the funding of EU research and innovation based on a ‘Common Strategic Framework’

– Greater simplication to release researchers and innovators from red tape (but not like balloons I suspect) when they apply and have to account for funding

– Stronger leadership including a strengthening of the role of the European Research Council

– Maximising impact and value for money

You can also read the Commissioner, Máire Geoghegan-Quinn’s, speech at this morning’s press conference or her blog here for more details.  In fact one has to applaud the many and varied ways in which one can participate in the consultation process.  The main European Commission Research and Innovation website is also worth a look – it has to be one of the most colourful sites in the sector.

And for all those Euro-skeptics out there, it seems only appropriate to repeat the Wednesday evening TV mantra of ‘You have to be in it to win it.’

The news that Pfizer is to close its R&D facility in Sandwich in Kent has shaken us from our sleepy winter hollows.

I’ve been watching the reactions and comments come over the wires as I am sure you have.  This is clearly a company going through considerable transition as it tries to change with the times – see the Reuters round-up of their results today for a good insight.  And essentially its the sort of hard-headed business decision that US companies seem prone to take about their global operations when restructuring.

So, a comment on Pfizer’s view of the UK as a place to do science?  No.  As a place to do business?  Possibly. 

But perhaps we should treat it as though it were the former.  For, ultimately, the impact is the same.  The loss of a world-class R&D facility in the UK.  As others have said today, it shows we need to up our game in how the Government and those across research work with industry.

Meanwhile…and no link between the stories is intended…I’ve been absorbing today’s report by the European Commission (see also BBC News)  ‘ Innovation Union Scoreboard’  It looks at the research and innovation performance of the 27 member states of the European Union.  The basic story is that the UK is rated an ‘Innovation Follower’ (just outside the ‘Innovation Leader’ category) and is playing catch-up with those ahead of it at a slower rate than its peers in the ‘Follower’ group. 

If you look at the country profile for the UK on page 50 it says some complimentary things about the UK having an ‘open, attractive, research systems’ and the stats show we are above average in the number of non-EU doctorate students (relevant to the immigration debate surely) and public R&D expenditure.  On most of the remaining indicators the story is not so good.

The European Commission, whose way with words is to be eternally admired, says the report is evidence of an ‘Innovation Emergency.’  I am not sure what to do in an ‘Innovation Emergency’ are you?  Other than look for my patent box of course.

On the face of it you might think this a very Friday afternoon sort of article.  But, as a discussion of how European foundations operate in a research funding context, it is is extremely interesting. 

The news peg for it is that plans are afoot by the European Commission to present a regulation for a European Foundation Statute by the end of 2011.  Very simply the Statute would make it easier for foundations and charities to operate across the EU including raising funds.  The idea has been in the works for some time and there is a public consultation open until February 28th.  See the European Foundation Centre website for more information – they also have a very active research forum.

I am not that keen on the European Commission’s pitch that this would enable charities to fill the gaps left by cuts in public expenditure on research by EU Governments (remember that argument from the spending review?).  Nonetheless the idea of enabling charities to generate greater funds is to be supported.

You may be interested to know that AMRC has been successful in getting an ESRC internship this Spring to look at NGO activities in support of medical research across the UK – as a comparative study but also to help direct our efforts to build cross-border alliances.  Currently our strongest links are with equivalent organisations in the US, Canada and Eire.  I am certain we could play an important role in marshalling voices across Europe in the same way as happens among disease-specific patient communities.  And Genetic Alliance UK is well-known for its work in this arena.

Towards a European AMRC, that’s what I say.

A Happy New Year to you all.

Given that we are all likely to have to suffer several months of phoney elections wars not to mention the odd leadership coup that isn’t I thought it would be refreshing to start the year off with a hard, solid fact.

In 2008-2009, AMRC’s member charities funded 166 clinical trials in the UK to the cost of £69 million.  I mention that because today AMRC publishes its response to the European Commission public consultation paper on how well the EU Clinical Trials Directive has worked in practice since it came into law in 2001.

Clinical trials are research studies that involve patients or healthy people and are designed to test new treatments.  In recent years charities have shown increasing interest in funding trials as part of their overall research strategy (for more on what trials are and what they are not, have a look at this excellent leaflet and booklet published by UKCRC). 

UK charities are perhaps unique across Europe in both raising public donations to fund such work and in fulfilling the more traditional patient group role in terms of information and advocacy.  From events I have been involved which have involved Non-Governmental Organisations (NGOs) from other EU countries, funding trials is just not on their radar screen.

So we should be proud of the role that charities play in funding trials in this country.  And we should recognise that the sector has a very important part to play in shaping a revised Clinical Trials Directive in the common interests of patients and science.

Briefly, the current Directive is a good example – of which there seem to be all too many these days – of legislation passed with the right intentions but with little heed paid to the practicalities.  Few if any would argue with the Directive’s aims of promoting patient safety and achieving greater harmonisation and simplification across Member States.  But the result is law which has, at the very least, represented a significant challenge in terms of implementation.  At its worst we have seen an increase in regulation and bureaucracy, associated negative impacts in terms of costs and time-delays.  All of which are counter-productive to the ultimate aim of enabling clinical trials to be set up and conducted, safely and at the same time efficiently

In this month’s issue of The Times” ‘Eureka’ magazine, Mark Henderson has written an interesting piece about what one might call the ‘science deficit’ in the EU which lies at the root of  such law reaching the statute book.  I agree with his observations.  But we should not also gloss over the fact that the UK failed to engage early and activly in the process of crafting the Directive last time around.  It would be irresponsible of us to make the same mistake again in making this a better piece of legislation in the interests of patients.