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Reflector is Pharm Exec's Brussels correpsondent.
Reflector points to a number of recent alarm signals that have seen European pharma move further towards dangerous territory.
A frightening vulnerability underlies the supply of medicines. Occasional glimpses emerge of just how thin the ice is on which Europe's and much of the world's health is skating. Ignoring too many warning signs for too long may plunge more of Europe's pharmaceutical firms into the depths, and the consequences could be disastrous for patients.
This may sound too apocalyptic a vision at a time of such promise for medicine and for new medicines, when exciting new therapeutic avenues are being opened up by breakthroughs in science and technology. But complacency may be going out of fashion. A year ago, only a few dangerous radicals were predicting that sub-prime lending and the trading in complex instruments derived from it would provoke a global financial crisis. Now the Cassandras have been proved right. And a decade ago, those predicting catastrophic global warming were regarded as hair-shirted prophets who should be kept away from polite company. But in the run-up to the Copenhagen climate summit at the end of this year, no responsible government any longer doubts the scale of the risks the entire planet faces from man-made emissions.
One of the recent alarm signals the radiopharmaceutical shortage late last year has already been alluded to in this column. The European Medicines Agency (EMEA) has this month released a report revealing just how close to crisis this episode came. There is no need to enter into details here: last summer safety problems obliged the Dutch authorities to temporarily shut down the reactor in Petten (the Netherlands) that normally accounts for about 60% of all radioisotopes used as part of radiopharmaceutical medicines products in Europe, and about one third of the world supply. There are only four other reactors around the world used in the production of medical radioisotopes in Belgium, France, South Africa and Canada. At the time reactors in Belgium and in France were undergoing planned maintenance; the South African facility closed for routine maintenance in September. The supply of therapeutic products and diagnostic agents was thus imperilled.
On this occasion, some commendably fast footwork by regulatory authorities and manufacturers averted the worst effects. But the episode demonstrated the weaknesses that can spring from comfortable and careless assumptions. EMEA has since urged some serious rethinking, including better co-ordination of scheduled maintenance of reactors, standardisation of uranium targets used in the different reactors in the European Union, and planning for replacement sources, since most of the reactors currently used in the EU and worldwide for the production of radioisotopes face permanent closure in 2015, when they reach the end of their working life. A task force of scientists, clinicians, regulators and industrialists has also been set up to explore possibilities for alternatives to radiopharmaceuticals in diagnostic and therapeutic procedures.
Radiopharmaceuticals is a relatively small component of healthcare. But what is true for radiopharmaceuticals is also true, in some respects, for the much bigger sector of vaccines. For years, vaccine manufacturers a similarly select group have been pointing out that neglect of effective contingency planning by public authorities is leaving the entire world vulnerable to supply shortages in the event of a major pandemic. SARS and bird flu are only the latest scares that have shown that, in an increasingly globalised world, infections in one continent can quickly and easily spread elsewhere. Outline planning for responses by health authorities has repeatedly suggested up-scaling of vaccine output in the event of an emergency. But as manufacturers have equally repeatedly pointed out, unless provision is made for keeping spare production capacity available (and few governments are prepared to make such provision) then sudden up-scaling is just not going to be possible.
Now the latest threat much wider than merely to sub-sectors such as radiopharmaceuticals or vaccines has come as a knee-jerk reaction to the current economic crisis. Ulla Schmidt, the health minister of Europe's largest economy (and largest drug market), Germany, has just suggested that all pharmaceutical manufacturers should adjust their pricing policies for reimbursed medicines to take account of public spending constraints created in the wake of the credit crunch. This could be the start of an extremely slippery slope. Public funding is being made available to rescue banks and carmakers, but at the same time pharmaceutical companies are expected to cut into their own profits to bail out national health authorities. This could tip whole swathes of the industry's manufacturing capacity and research over the edge, with consequences for jobs, revenue generation and innovation. If drug firms do not vigorously reject such a stratagem, they could find themselves damaging their own health, and that of their patients too.