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EU conundrum

With Blair's premiership in its twilight years, Roy Lilley asks if he will be able to make his mark on Europe

About three million years ago, I can remember the first time Labour had a serious go at running the country. They got into a terrible mess. We owed a shed load of money to something called the International Monetary Fund (IMF) and the situation got so grave that we needed to borrow a shed load more.

Denis Healy was the Chancellor of the Exchequer at the time. He was unceremoniously summoned by the gnomes of the IMF to explain his fiscal and monetary strategy. Embarrassing, or what?

Healy was a very good photographer, a raconteur and loquacious speaker. I think history will judge him all fingers and thumbs when it came to juggling the nation's finances. Nevertheless, as an orator he gave us the image of being 'savaged by a dead sheep'.

He defined the difference between tax avoidance and tax evasion as being the 'thickness of a prison wall', and he was the man who said: 'When you're in a hole, stop digging.'

Healy got into a mess with foreigners and Labour looks set to do it again. Europe is in a hole, everybody is digging and the hole is getting deeper!

Tony Blair, a fluent French speaker, did the rounds to try and figure out the extent of the damage before he took over the EU presidency for his six months.

Bear in mind that, after being chastened by a lacklustre election result, he said he was going to concentrate on hospitals, schools, and law and order.

Under reform
Reform of public services has been more tricky than he thought. Modernisation, money and more targets than a shooting range haven't really produced much that is memorable.

In the twilight days of his premiership, he is saddled with a battle over old Europe, insane financing and a 25-strong membership that is about as diverse as NASA and a bicycle, and not much time to turn it all around.

Italy is demanding its Lira back. Germany, paralysed by an election result as dense as a Bavarian sausage, wants its economic glory days back. Denmark wants a new government. Luxembourg wants to know what's going on. Poland wants to keep sending its plumbers to France, and France wants to keep giving its farmers gold plated shovels. It is a mess.

Recent reports said Tony Blair had warned France that the EU would never regain the confidence of its citizens unless President Chirac agreed to far-reaching changes in its priorities and direction. That's code for: substantial reductions in the money channelled to French and other farmers, and an end to the traditional dominance of the Franco-German alliance.

Blair's message, delivered after what were clearly tough talks with Chirac, was intended to direct attention away from Britain's £3bn budget rebate and back towards France's rejection of the EU constitution.

If we want to reconnect people withthe idea of the EU, we have to set a new political direction and reconnect the priorities which the people have with the way we spend money, said Blair.

Then there is the constitution. Call me sad, call me an anorak, call me a nerd and send me a bobble hat ñ but I confess, I have read it. It is not a bodice ripper but it is bloody clever.

Read it as a Euro-sceptic and you will be ready to slash your wrists. Read it as a Europhile and you will be ready to break open the champagne. All sides can claim it goes too far, not far enough, is too complicated, too simple, too transparent, is hiding things: it is a masterpiece.

In truth, it is probably a serious attempt to make sense of the nightmare of enlargement, accession countries, democracy, voting and all that sort of stuff that might make a disparate group of countries arrive at the odd sensible decision.

What of health?
So, where are we and what are the implications for Euro-health?

Although the European-based pharma/biotech industry is still making a bob or two and a sizeable contribution to the EU's trade balance, employment in science and public health is declining in relative terms compared to the US. Europe also faces growing challenges from India and the Far East.

The big problem is that there is no single market in pharma. National systems of pricing and reimbursement, assessments of cost/clinical effectiveness and all the rest of it, vary enormously leading to an uncertain climate for investment and varying access times to the market.

They say one of the great things in life is to be in the right place at the right time. Tony Blair certainly has the knack. Presidency of the EU (and having chaired the G8) gives him huge leverage to deal with the host of issues he faces.

Let's take a look at them:
Third World debt is all but written-off, shifting the focus to projects dominated by education and health. Pharma has had difficulties in marketing in Africa ñ everyone wants the drugs and no one can afford to pay for them. There is likely to be a shift in this equation.

The UK has identified nutrition and obesity as priority issues for its six-month term; issues that have already been high on the agenda of other EU institutions, in particular for European Commissioner Markos Kyprianou.

Blair will be looking to make real progress on a number of nutritional issues. He is also expected to continue to reduce inequalities in health outcomes.

There is a shadowy, so-called, high-level group on health services and medical care established by the Commission in response to a report on patient mobility and healthcare developments in the EUin December 2003.

You can bet the UK will pursue the work done to facilitate this and assess the importance of developments in the internal market for health systems. This might have profound implications for pharma.

It is highly probable that Blair will want to evaluate the EU e-health strategy and think about what comes next. We all know IT is the cornerstone of all modern-isation programmes.

The UK Presidency is also likely to want to continue to support the ongoing work on legislative proposals for regulating pharmaceuticals for children, tissue engin-eering and the revision of legislation on medical devices. All very important for Euro-pharma to keep an eye on.

If this is starting to sound like a list, that's because it is. There is a lot coming up and Euro-pharma will miss it at its peril.

Love or hate him, Blair understands that the public wants the EU to deliver tangibles. He has got the message andthe smart money is on him delivering.

There's more
Let's not forget the ongoing work to prepare the EU for pandemic diseases. The EU is taking this very seriously and there is a planned simulation exercise on communicable disease control in the diary for November 20-22.

After that, the developing European Centre for Disease Prevention and Control will acquire a new prominence and, inthe UK, the Public Health Executive isdue to be operational round about now.

The emphasis on patient safety is good news for our own chief medical officer, Liam Donaldson, who is also chair of the World Health Organisation Alliance for Patients. One of the main points on its agenda will be anti-smoking.

In all this, however, there is one issue the great and good have left out. There is one thing they could do that would change the face of the pharmaceutical industry forever: putting medicines of value in front of poor patients more quickly.

It's not rocket science but they either won't do it, can't do it, or haven't thought of it. What is it? Simple. The biggest problem pharma faces is keeping new medicines affordable. R&D, patient safety, confidentiality and interminable trials means that by the time pharma is sure it has something safe that works, about 14 years of patent life have expired.

Then there is designing and setting up manufacturing facilities. That leaves about six years to launch the product, establish the brand, get doctors to prescribe it and health system payers to fund it.

Is it any wonder medicines are so expensive? As drugs, many of which deal with end-stage conditions, become more sophisticated, payers are left with mind-boggling moral and ethical dilemmas about how to afford them. This is only going to get worse.

The solution? If Blair wants to mark his presidency as well as make his Prime Minister-ship truly memorable, he has one simple task: change EU patent law and allow pharma a two-stage protection: R&D protection and marketing protection. He could be remembered for putting medicines within the reach of people.

R&D patents could extend to no more than 10-15 years, and marketing authorisation for a further similar period. That way, pharma is not compressing its cost recovery, marketing costs and profit margin into a barmy six-year period.

Cost recovery and margins could be recovered over a longer period, prices would be saner and more healthcare systems and patients would benefit.

Yes, there are probably a thousand ways to cheat, fiddle and defraud a system like this but it would be the job of the regulators to make sure it didn't happen.

Europe is grinding to a halt. It won't work with 25 disparate economies, electoral systems, national identities and let's not forget the languages. Post-enlargement, the EU has 20 languages with equal rights as official and working languages.

All can be used in communication within and with all the EU institutions. Translation of regulations, directives, and draft documents must be ensured for each and every one of them. Estimates suggest that after enlargement 2.5 million pagesa year will have to be translated for theEC alone. The cost of that is Ä800m.

Goodness knows how much it is in proper money. In case you are interested, I make it that 20 languages creates a total of 190 possible combinations.

Europe is in a hole. Healy was right we should stop digging; do the simple stuff, adopt a common EU working language and ensure people get the medicines they need. Tony, that's the job, the people's priorities ñ and the heritage.

The Author
Roy Lilley is a healthcare author and broadcaster

2nd September 2008

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