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Europe's pharmaceutical R&D has recently come under a barrage of criticism. Nobel laureate, Kary Mullis, highlighted the issue of over-legislating biotechnology and the business industry expressed its dismay concerning the EU's overly cautious approach to any kind of development. Action is needed before the sector's future resembles the plot of a Shakespearean tragedy.
Last month, a Nobel prizewinner urged Europe to take a more positive approach to health technology. Dr Kary Mullis, who won the Nobel Prize for chemistry in 1993 for the discovery of the polymerase chain reaction, advised the European Parliament (EP) that Europe was exaggerating the risks of biotechnology and was in danger of passing up valuable opportunities by being too cautious. Delivering the inaugural annual lecture for the EP's Scientific and Technological Options Assessment office, he said Europe should take account of the opportunities of the biotechnology era. He put into perspective what he referred to as the 'hysteria' surrounding biotechnology. "The new vocabulary of biotechnology scares us. What was once called horticulture is now called genetic modification," he stated.
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"Politicians are over-legislating," he charged. He criticized them for demanding that up to 35000 chemicals, as yet untested, be monitored for toxicity - because it would lead to companies jumping on a bandwagon that should never have been set in motion in the first place - in the search to make money out of unnecessary testing. It would be impossible to test every single chemical for its possible effects on the endocrine system. "Everything is a chemical, there is an infinite number of chemical combinations and doses," he said.
But Mullis failed to convince all his audience. Nuala Ahern, Euro-MP for the Irish Green group, alleged that research proved that the male reproductive system is affected by the release of genetically modified organisms, and Greek socialist, Konstantinos Alyssandrakis, claimed that the rapid rate of advance was driving biotechnology into fields that were "not always in equilibrium with the environment."
During the same week, the EP committee for the environment and public health backed a call for tighter controls on another of the frontier technologies for health. It said there should be tougher limits on the donation, procurement, testing, processing, storage and distribution of human tissues and cells. The European Union (EU) has already proposed new rules in this area, but the Parliament committee demanded that they be toughened up.
It said there should be wider scope for the new rules, to ensure the traceability of tissues and cells of human origin. Guarantees were needed on donor consent and donor anonymity, it advised, and the committee urged further attention to be paid to the ethical issues raised. It insisted on a prohibition of research on human cloning for reproductive purposes and research designed to create human embryos solely for research purposes or to supply stem cells, including by means of the transfer of somatic cell nuclei. No tissues or cells derived from human embryos may be used for this purpose, it argued. And cloned human embryos and human/animal hybrid embryos produced by cloning, aggregation or any other procedure, and cells and tissues derived from them, should be excluded as sources of material for transplant.
Many Euro-MPs on the committee said that even though there was bound to be a role for the private sector in this field, more encouragement should be given to strong public and non-profit sector involvement in the provision of tissue and cell transplant services, and the related research. Exceptionally, regenerative tissue and regenerative cells may be retrieved under strict conditions, such as when the recipient is a sibling of a donor, the donation is potentially life-saving for the recipient and the potential donor does not refuse.
The committee member in charge of the discussion - the rapporteur as he is termed in EU jargon - was German doctor and Euro-MP, Peter Liese. He cheerfully recognized that the transplantation of cells and tissue is a rapidly expanding field of medicine that offers great opportunities for patients who have so far been suffering from incurable diseases, and great potential for economic development. But he also stressed that "this new therapy also carries with it certain risks" - as, he claimed, was proved by experience in the US.
So, on the one hand, although he said that the increase in cell and tissue transplantation and tissue engineering is to be welcomed; on the other hand, "care must be taken to ensure that quality and safety standards are observed and that fundamental ethical principles are respected." He evoked "the scandal of HIV-contaminated blood products … painfully present in the minds of many." And he went on to warn that cell and tissue transplants "present a greater risk than treatment with blood products" because procedures are lacking for destroying pathogens and the therapy process is very new. "There have already been fatalities that could have been avoided by observing stricter standards," he said.
Among the changes, Liese urged for - and won backing from his fellow committee members - was an integration of ethical issues into the new rules. Blood safety and quality of cells and tissues cannot be considered irrespective of the ethical issues, because the manner in which cells and tissue are obtained will have an effect on quality and safety, he claimed. "The view is expressed that it is not appropriate to regulate ethical issues such as informed consent or voluntary unpaid donations under a European directive. Your rapporteur firmly rejects this view," he insisted, claiming that existing EU rules on blood products, on clinical testing and on biotechnology patents "are unequivocal evidence that matters, which are generally regarded as ethical issues, can be regulated by the EU."
Liese accepts that there is "great controversy" in the member states and in the EP regarding the use of human embryonic stem cells and the cloning of human embryos. A majority of Euro-MPs has always rejected the production of embryos for research purposes and the cloning of humans at all phases of their development, he pointed out - even if, as he acknowledged, there are differing opinions regarding what approach to adopt to embryos produced for the purpose of artificial insemination and to embryonic stem cells in the laboratory.
In the business community, there is increasing dismay concerning these repeated calls for caution in every aspect of pharmaceutical development - whether it be the direction of research, the economics of the industry or the cost of health care. Brian Ager, the normally quiet-spoken director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), was driven to extravagant language recently when he defended the industry at a London (UK) conference.
"The European pharmaceutical industry is a key asset," he insisted, "one of the leading high technology sectors in Europe." Citing its ‚18.8 billion research spend, its ‚28 billion trade surplus during 2001 and its 560000 jobs, he described it as "a leading contributor to the EU science base and economy" making an "undeniable" contribution to health care.
Yet, he went on, the industry is now at a crossroads because of government pressures to control health costs, tighter regulatory demands and controls, a deteriorating EU climate for business and escalating research costs. Most EU markets still do not allow drug firms to price their own products, there are widespread delays in market access for new medicines and the trade distortions in the fragmented EU market are about to be increased by EU enlargement. Above all, he spoke of "regulatory overkill" through "the patchwork of national controls" in Europe. "The world is getting tougher," he said, and "We need a new way forward."
Ager repeated the industry's long-standing calls for encouragement for research and development (R&D) through the stimulation of research and adequate intellectual property protection, and adequate rewards for innovation by giving new medicines rapid access to the full European market at "equitable prices." And in a final gesture of impatience, he demanded that the EU should, at last, move to "actions, not just words."
EFPIA's president, Sir Tom McKillop, CEO of AstraZeneca, has recently been making the same point. "The pharmaceuticals industry is a major investor in EU R&D and a revealing barometer of innovation in Europe during recent years," he said in a recent statement. It is also a signpost to a possible road ahead to a better R&D future.
He too embraced the 'crossroads' theory: "Although we are still one of the leading high technology sectors, we face the challenge of declining competitiveness in the face of our main competitor, the United States," he warned. The US now represents 47% of the global market, having risen from 31% during the last 10 years. During the same period, European representation has decreased from 37% to 24%, said McKillop. And "the US appears more enthused by new scientific advances and Americans seem more interested in science itself."
By contrast, "In Europe, patients are less well informed and health care systems are slower and less willing or able to accept, adopt and integrate new technologies." He attributed some of the slowness in access to regulatory delays in obtaining market approval, and to "the significant time needed for negotiation between companies and governments regarding the pricing and reimbursement of new products" - in some EU countries "with prolonged delays well in excess of a year."
It's all at stake in the immediate future, McKillop argued. "A top level debate is currently taking place involving the European Commission, national governments and EFPIA - representing the research-based pharmaceuticals industry - which will decide whether Europe will maintain or, more desirably, improve its innovative strength during the coming years."
What the EU has to do now, he said, is to develop some of the fine principles that have been enunciated by EU authorities into practical steps that will deliver a more competitive European environment for pharmaceuticals and health care. For McKillop, one of the principal targets is still the industry's old concerns regarding parallel trade in medicines between EU countries. He estimated they now affect sales of approximately ‚3.5 billion per annum, "and could be costing the R&D-based industry as much as ‚1 billion, much of which could have been re-invested in research and innovation." Overall, he said, the significant growth of parallel trade in recent years undermines the attractiveness of Europe as an environment for the pharmaceutical industry. As a result, there is a trend to increase investment overseas, he alleged; at the moment, investment in R&D in the US is growing at twice the rate of Europe. During the last 10 years, even the major EU pharmaceutical companies have changed the distribution of their R&D spending to the benefit of other regions.
And for the EFPIA president, the prospect of EU enlargement makes this problem even more acute. "Changes resulting from enlargement could further weaken the European pharmaceutical industry through increased parallel trade," he warned. "All parties must work with the candidate countries to ensure that they achieve the full benefits of accession without damaging the EU health care market through parallel trade."
Hamlet-like, Europe's pharmaceutical industry is poised between success and failure: external circumstances are not entirely propitious for its success - particularly the disregard for its capacity for imagination and innovation. So now it must decide: "Whether 'tis nobler in the mind … to take arms against a sea of troubles, and by opposing end them."