Death of EU gene patents directive

NEWS The report has

WASHINGTON PERSPECTIVE

Resounding echoes of Gallo

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set

off other William

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A explosions. NIH biophysicist and member of the National Academy of Sciences, wrote that all the royalties

ondary Hagins,

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Did Robert C Gallo, the renowned report in the Chicago Tribune drew a vitriolic letter from Dr Bernadine v should go to Pasteur and that Varmus virologist at the National Cancer Institute, misrepresent his part in the Healy, National Institutes of Health should apologise to Pasteur "on identification of the AIDS virus, and director, who is accused in the report behalf of present and past officials thereby cheat the Pasteur Institute of of shielding Gallo from government who engineered this appalling scientific glory and patent royalties? : investigations. Noting that the report coverup, and on behalf of the scienwas produced under Dingell, she tific staff of NIH". In 1992, after a long investigation, Hagins added: "I realize that Dr described it as a "package of fabrica- : the United States government said Varmus would likely be fired in short tions and distortions" and Dingell’s that indeed he did. But the govern"final spasm" after the November order if he attempted to do any of ment, unsure of its ability to prove a scientific case in a legal forum, withelection. : this ... For him, it would be a wonderful opportunity to become known As the report got around, it prodrew its findings of scientific misconduct after Gallo moved to appeal. duced further eruptions. Upon as the first NIH Director who actualHowever, last year the USA yielded receiving a copy from Serge Lang, a ly stood for something besides the efficient absorption of federal funds". the French a greater share of royalYale professor of mathematics interWith formal charges withdrawn v ; ties on the HIV blood test-and ested in misconduct issues, Dr and no official body pursuing the Gallo said he was looking for another Kenneth Ryan, of Harvard Medical : School, chairman of the Commission case, it is likely to fade away. job. Case over? Officially, yes. But, in on Research Integrity of the DepartDaniel S Greenberg bizarre ways, the Gallo case has ment of Health and Human Services, stated that he would make copies for recently been rumbling again, followmembers of the Commission, adding Death of EU gene patents ing the samizdat-style circulation of a "It obviously should inform our work directive that was three in report years preparation by congressional staff memand help in our deliberations". ; bers working for Representative John Two weeks later, Ryan received ’. The European Parliament has vetoed, by 240 votes to 188, the final draft of the : another copy, this one from two selfDingell. No need for furtive distribution in appointed monitors of scientific . Gene Patents Directive after 6 years of the electronic era. The 267-page integrity, Ned Feder and Walter debate. The text originally proposed by the Stewart of NIH. In 1993, exasperatreport is on the Internet, accessible Commission sought to establish European to the World Wide Web at: : ed by their independent investigathe conditions under which biotechnology tions and on ’. pronouncements http ://nyx10.cs.du.edu: 8001/patents might be granted in Europe. A key wstewart/ and entitled Institutional integrity matters, the NIH manageconsideration was the long-running ment reassigned them to routine ’. Response to the HIV Blood Test Patent and Matters. administrative duties, and directed Related : Dispute election them to stay off the fraud beat on November’s congressional returned Dingell to office but forced However, in government time. him from his powerful chairmanNovember, NIH said they could accept an invitation to testify to ships, and the authors of the report no longer work for Congress. FurRyan’s Commission. In response to a ’. not did authorise thermore, Dingell request to send along anything that release of the report. He has since might be of interest to the Commisissued a foggy statement regarding its sion, they sent Ryan a copy of the Gallo report, along with a spicy letter status, saying the review process had not been completed before the elecurging him to rid science of corruptoral changes. Nonetheless, the caretion. They also sent a copy of the work is documented of fully piece report and a similar letter to NIH difficult to ignore. : director Harold Varmus, of whom the report does not speak kindly. Reaffirming the findings against ; For their efforts, Feder and StewGallo, the report also asserts that senior US art each received an "Official Reprigovernment officials became so mired in protecting his mand" last month, from the NIH research claims that "Defending the official who gave them permission to indefensible became a reflex, until testify to the Ryan Commission. The ultimately, the cover-up was so burspecific offence cited was use of NIH dened with falsehoods that its col- : stationery in writing to Ryan, an act lapse was inevitable". ! described as "a flagrant violation of Strong words, and together with : my directive to you that you are not

others of a similar nature, the Gallo report has prompted strong reac- : tions. In January, an account of the

use government resources for activities related to scientific misconduct".

to

transatlantic dispute arising from the recognition accorded to "discovery" in US patent law, as opposed to European requirements for evidence of "invention". In the European Parliament, the minority Green group had provoked considerable nervousness in the powerful

agricultural lobby by repeatedly saying that farmers would have to pay royalties on the progeny of patented animals and seed collected from patented plants. But

the decisive consideration for the Socialists, who form the largest group in the assembly, was the wording of a key passage of the directive on human genetic medicine. The compromise that emerged from conciliation talks between the Parliament and the Council of Ministers on Jan 23 reiterated that "human beings, the human body or parts of the human being" could not be patented. The definition of those terms had been extended under parliamentary pressure to include "a gene, protein or cell in the natural state in the human body, including germ cells and products resulting directly from conception". But the text went on to specify that : inventions should not be unpatentable because of their human origin when this

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involved, for example, "an invention including industrially applicable parts obtained in a technical manner from the human body in such a way that they can no longer be ascribed to a particular individual". This would have applied even when the structure of such invention was "identical to a part of the human body". : This revised wording failed to satisfy : those MEPs fundamentally opposed to ideas of commercial "rights to life", especially among the large German Socialist contingent. One of them, Evelyne Gebhardt complained that the directive was still too vague and left room for different interpretations in areas where "total clari- : ty" was necessary. Elsewhere, the absence from the text of an unqualified prohibition of germ-line therapies would leave the door open for future recourse to these techniques, she said. : There have been mixed responses to the veto. The enviromental group Greenpeace hailed the "responsibility" shown by the assembly in "preventing the genetic engineering industry gaining monopoly control over human genes and animals and plants through the use of patents". That view was not shared by Willi Rothley, the hapless German MEP who had spent 5 years steering the proposal through its parliamentary scrutiny, as

Cheap German re-imports of pharmaceuticals The Federal Court in Karlsruhe has ruled that "re-imports" of drugs produced in Germany itself or by daughter companies . of German firms abroad are permissible. These drugs are often cheaper abroad than in Germany and German wholesalers and chemists can take advantage of this price difference. For example, 20 aspirin tablets manufactured by Bayer cost DM 6.85 in Germany but re-imported, they might be available in pharmacists’ shops for less than DM 5. Re-imported drugs

Swiss law for safer blood decree for intensifying of blood supplies, scheduled to come into force on Jan 1, is awaiting approval by Parliament. The Federal Public Health Office will become responsible for ensuring that all blood products undergo thorough standardised tests, including those for hepatitis B and C, and for HIV. The same will apply to organ transplants. Blood donors will be required to complete a detailed questionnaire. : The new measures are in accordance with the recommendations of the Blood and AIDS working group set up by the Ministry of the Interior after it was established that blood products supplied to hospitals by the Swiss Red Cross-the : body handling almost the entire distribuA government

quality control

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rapporteur for the assembly’s Legal Affairs Committee. But he chose his words with care because it was his own Socialist colleagues’ opposition to the draft that sealed the fate of the proposal. : Rothley pointed out that the decision would do nothing to impede the steady stream of gene applications to national patent offices-and to the non-EU European Patents Organization (EPO) in Munich, which operates under the terms of convention law. "I am not sure that the Parliament has not made a mistake", said Rothley. "The Parliament’s victory may prove to be pyrrhic because patents will continue to be awarded", he said, adding that the EPO is already receiving applications involving germ-line therapies. "In the EU, we did have the chance to influence patent law and we must have lost that opportunity", he said. : But other MEPs insisted that the vote would have an impact on policy: the very absence of EU legislation would deny governments the opportunity of behind the pretext of "law imposed from Brussels" to avoid national debate on awkward ethical issues. These members predicted that national administrations and the EPO would take heed of misgivings raised in the European Parliament’s years of debate.:

Views also diverged on what the loss of the directive would mean for the research community. Mario Monti, the European Commissioner responsible for "single market" trade issues warned the Parliament on March 1 that a vote against the directive would "push the EU out to the fringes of biotechnology research effort". Without a harmonised EU framework of rules, he said, "other people will do this work in the USA and Japan and prices in the EU will suffer". Moreover, the whole issue of what "ethical guarantees" should be demanded would pass out of European control. But biotechnology industry spokesmen were less than devastated by the Parliament’s decision. Dr Nicholas ScottRam for the UK Bio Industry Association commented: "Those who argue that the Parliament’s vote represents a disaster for European research are going a bit over the top". He and others felt it would be a matter of "business as usual" with the EPO and national patent offices. Technically, the directive is now "dead", although the European Commission could conceivably come forward later with a heavily revised version.

are recognised by the Federal Drug Agency : In Germany 95% of the drugs are sold to the pharmacists via wholesalers, whose payment is directly proportional to the over-the-counter price of the drugs. At present only 1 % of the drugs on the Getman market are re-imported, whereas in

health insurers and patients of DM 560 million. However, these estimates are thought unrealistic by the German pharmaceutical industry. They point out that most of the 500 to 800 re-imported drugs (mainly for cardiovascular diseases and pain killers) are competing with both generic and proprietary drugs. They claim that higher drug prices in Germany-on average 10 to 15%-are justified through the higher cost of drug development and the value-added tax rate of 15%, and that the public is prepared to pay a premium for quality products.

hiding

Great Britain and the Netherlands the is about 8%. : The court decision was welcomed by federal Minister of Health, Horst Seehofer, as well as the largest obligatory health insurer, AOK. "The German market has become more European", he said, welcoming the estimated savings for amount

tion-were the source of HIV infection among a number of patients, including haemophiliacs. The Public Health Office estimates that 80-100 people were infected by HIV-contaminated blood between 1982 and 1993 (see Lancet 1994; 343: :

797). The sole person to have been formally charged so far as a consequence of these infections is Prof Alfred Haessig, 74, the then director of the Red Cross central laboratory. He is accused of having allowed preparation and sale of blood derivatives in which HIV contamination a suspected possibility. The next juridicial step-an examination of the was

context in which contamination about-was to have been taken in Geneva, from Feb 28 to March 24. The investigating judge had summoned some

entire came

Arthur

Rogers

Annette Tuffs

witnesses, 18 of them doctors (includ10 professors) for hearings behind closed doors. At the last minute, proceedings were postponed, at least until next month, because Haessig, who has rejected the accusations against him, was in hospital following a heart attack. Legal moves in the Geneva court started in May, 1992, with a complaint lodged by a 27-year-old haemophiliac. His example was followed by six haemophiliacs and 30

ing

other persons elsewhere in the country who had received transfusions. The federal high court then decided that all such cases should be heard in Geneva because of the expertise involved. In the meantime one of the haemophiliacs has died. Their lawyer is seeking to have charges brought against other officials. three

Alan

McGregor