Wednesday, May 07, 2008

It's not that hard to understand (or maybe it is)

For years the big pharmaceutical companies have been the enemy. In fact, they have been THE ENEMY. While I consider that large corporations and conglomerates do tend to be on the other side of the divide in matters that involve competition, I cannot, perhaps because of certain personal events in my life, quite view the pharmaceuticals in that light. In fact, I never cease to be amazed by the developments in medicine that have taken place in the last thirty to fifty years. Of course, a good deal of that is thanks to developments in public health, made over the last 100 – 150 years, many of which our hospitals seem to be abandoning now, but that is a separate issue.

Pharma has been on the receiving end of attacks, excoriation and endless regulations. This posting is not intended as a detailed analysis of them all but a comment on the peculiar mentality or people who think they are in a position to run others’ lives.

This press release came my way earlier today. The title is “Innovative Medicines Initiative boost for Europe's pharmaceutical industry” and the idea is the usual straightforward way: let’s form another organization, throw lots of taxpayers’ money at ti and it will produce results that will put “Europe” ahead in the game. Fill in the blanks for what it is you want to get ahead in.
With the launch of its first call for proposals, the Innovative Medicines Initiative (IMI) got underway on 30 April. Joining forces, the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) hope to bring Europe back to the forefront of medical innovation.

Over the next five years, those two primary partners in the IMI Joint Undertaking (IMI JU) will invest €1 billion each, with an initial €123 million being channelled into research projects already in the 2008 funding period.

Following ARTEMIS (Embedded Computing Systems), ENIAC (Nanoelectronics Technologies 2020) and Clean Sky (Aeronautics and Air Transport), IMI is the fourth Joint Technology Initiative (JTI) to be launched.
Then there are details of what the research should concentrate on with a certain amount of self-congratulation and some breast-beating:
Europe's pharmaceutical industry still produces 35% of the world's pharmaceutical output, making it the second largest player in medicines manufacturing behind the US. The industry also important contributor to the European labour market: In 2004, the number of employed exceeded 612,000 with 103,000 highly-skilled employees in the research area.

However, Europe has lost a lot of ground in the area in recent years. Commissioner Potocnik stressed the fact that Europe once used to be called 'the world's pharmacy' with seven out of ten new medicines developed and produced in Europe some ten years ago. Today, however, a mere three out of ten new medicines are come from Europe.
The idea that scientific progress should be measured in the number of people employed is rather strange. Reminds me of the discussion in the dear departed Soviet Union about the number of writers there were from Tula province in the Writers’ Union. I can’t remember the exact figure but it was higher than the pre-revolutionary, which was one. The problem was that the one was Lev Tolstoy. Still, as Friedrich Engels said, quantity becomes quality.

Back to the pharma in Europe, which is underperforming but will no longer do so under the benevolent gaze of the Innovative Medicines Initiative. At the very end of the press release we find that there is a definite reason why there has been all this underperforming:
Speaking on behalf of the EFPIA, the federation's president Arthur Higgins pointed out that there is a growing concern in society about the need to spark pharmaceutical innovation. At the same time, the pharmaceutical industry is faced with increasing regulatory hurdles in a strategy of risk avoidance, he said, adding that 'there cannot be therapeutic roses without thorns.'

Meanwhile, the average cost for bringing a pharmaceutical product to the market has risen to approximately €1 billion. In addition, the challenges in biomedical sciences were increasingly more complex. 'We are the first to admit that we cannot solve all of these problems alone,' said Mr Higgins. He therefore called on all stakeholders including small and medium-sized enterprises (SMEs), academia, research centres, patient groups, public authorities and the research-based pharmaceutical industry to actively participate in new JTI.
Forgetting about the split infinitive for a moment, let us consider the fate of those SMEs that find themselves priced out by the ever increasing number of “regulatory hurdles” brought in as a result of pressure from various lobbying organizations, often with health and safety issues in mind.

What never ceases to amaze me is the insouciance of the regulators who first make it hard for businesses and enterprises to compete because of high taxes and even higher regulations, then use those taxes to set up official organizations and instruct the businesses to forge ahead. Anyone would think that entrepreneurship and development is something that can be legislated.

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