BioWorld International Correspondent
BRUSSELS, Belgium - The European Agency for the Evaluation of Medicinal Products is setting up a new working group on pharmacogenetics as a response to the pace of development in the field. The aim will be to foster dialogue both among European experts and between the EMEA and companies.
The EMEA rationale is that large quantities of exploratory scientific data are being generated with the use of pharmacogenetic and pharmacogenomic approaches. To ensure that the assessment of marketing authorization applications can benefit from the required expertise and from clearer understanding of all surrounding issues, the new group will monitor technical progress in the field. It also will provide input on pharmacogenetics to the EMEA, the European Union's medicines regulatory agency in London, for the preparation of regulatory guidance - and act "as a dedicated forum for briefing sessions with sponsors," according to the announcement of the group's establishment last week.
The briefing sessions with sponsors are intended to be informal discussions covering any jurisdictional, regulatory or scientific aspects raised by a firm's planned drug development programs using pharmacogenetic approaches. The talks could take place prior to any formal approach by firms to seek scientific advice or to submit applications to the EMEA. And they will be in a format that respects their "highly confidential nature" - with any reports remaining as internal confidential reference documents, and with all participants bound by confidentiality undertakings, and obliged to declare any potential conflict of interest in advance of each session.
Nobel Prize Winner Defends Biotech In Parliament
Nobel Prize winner Kary Mullis told the European Parliament last week that Europe was exaggerating the risks of biotechnology. Delivering the inaugural annual lecture for the Parliament's Scientific and Technological Options Assessment office, he said Europe should take account of the opportunities of the biotechnology era, too.
He put into perspective what he referred to as "hysteria" surrounding biotechnology: "Genetic modification is nothing new," he contended, citing such precedents as corn, wheat and seedless watermelons.
"The new vocabulary of biotechnology scares us. What was once called horticulture is now called genetic modification," he said. He argued that biological warfare was no new phenomenon, either.
"Politicians are over-legislating," he charged. He criticized them for demanding that up to 35,000 chemicals, as yet untested, be tested for toxicity - because it would lead to companies jumping on a bandwagon that should never have rolled 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, who won the Nobel Prize for chemistry in 1993 for the invention of the polymerase chain reaction, failed to convince all his audience. Irish Green Group Euro-MP Nuala Ahern 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."
Closer Checks On Tissues, Cells Called For
The European Parliament committee on the environment and public health last week backed a call for tighter controls on the donation, procurement, testing, processing, storage and distribution of human tissues and cells. The committee welcomed proposals for new European Union rules in this area, but demanded that they be toughened.
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 said, but in the case of gametes, it should be possible to waive anonymity in order to respect the right of children to know their genetic parents.
The committee urged further attention to ethical issues. 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 if there was bound to be a role for the private sector in this field, more encouragement should be given to strong public- and nonprofit-sector involvement in the provision of tissue and cell transplant services and related research. Exceptionally, regenerative tissue and regenerative cells may be retrieved under strict conditions, such as where the recipient is a sibling of a donor, the donation is potentially lifesaving for the recipient and the potential donor does not refuse.