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OTTAWA - A new federal law extending patent protection on new drugs will lead to a doubling of R&D spending over the next decade, Canada's pharmaceutical manufacturers have promised. But this $1.4 billion (Canadian) commitment, made through the 64- member Pharmaceutical Manufacturers' Association of Canada, has met with some skepticism. PMAC President Judy Erola acknowledged the problem when she testified last fall that "some have said that the industry has never invested this kind of money in the past so why would it be expected to do so in the future? We have not done so precisely because we were never sure that our investments would be protected for a defined period of time." A 1969 change in the patent act allowed generic drug manufacturers to produce copies of patented products once they had appeared on the market under what was called "compulsory licensing." This effectively reduced the patent protection offered the drug's originator, which was 17 years from the date of filing. BY TED AGRES Washington - A new law gives a civilian agency the authority to set standards on access to unclassified data, including scientific and technical information. The law ends a long debate over how to protect certain types of computerized data and wrests control of such decisions from the military. "We're very pleased," said Kenneth B. Allen, senior vice president of government relations for the Information Industry Association "It's a good piece of legislation. It doesn't address all of our concerns but it's a tremendous step forward." The law, called the Computer Security Act of 1987, passed The House last June after Frank Carlucci, then national security adviser, rescinded a 1984 administration memorandum to create a new category of "sensitive but unclassified" information. (See THE SCIENTIST November 30, 1987, p. 1). The Senate approved the measure on a floor vote shortly before adjourning last month; and on January, 8 President Reagan signed the bill. Administration officials initially opposed HR 145 because of fears that foreign intelligence agents could piece together national security secrets from information in unclassified computer databases. Many scientists and politicians; however, feared the 1984 memorandum would allow the government to restrict access to unclassified information contained in such commercial data bases as Mead Data Central's Nexis/Lexis and in libraries. The new law orders the National Bureau of Standards to set rules on civilian computer security. The Pentagon's National Security Agency is relegated to an advisory role but retains authority over standards for classified systems. Other aspects of the administration's information policies will be examined in the next few weeks at hearings before the Senate Judiciary Committee's subcommittee on technology and law. Of continuing concern are efforts to restrict presentations at scientific symposia and the impact of such policies on the country's worldwide economic position. Agres is assistant managing editor at The Washington Times. The pharmaceutical manufacturers claimed that compulsory licensing was disastrous for them. Under the new law, patent protection is assured for 10 years from the day the new drug is marketed. The PMAC supported this bill because, as Erola said, while it "does not provide a full 17 years of protection for our products, and does not. repeal compulsory licensing, it nevertheless does restore a fairer period of' protection for our products. Part of the skepticism about the likelihood of more research-specifically, an increase in R&D spending from 4.9 percent of sales to 10 percent, or $3 billion, by 1996 is based on the fact that most Canadian drug manufacturers are subsidiaries of multinationals based here. It was believed unlikely that such firms, mostly in the United States and the United Kingdom, would duplicate existing research facilities. Nevertheless the PMAC has published a list of Canadian investment commitments totaling $937.5 million for the next 10 years. Some 18 firms are named, while three commitments include the site of research without firm names attached. The firm with the biggest commitment, Merck Frosst Canada Inc., is a subsidiary of Merck and Co. Inc. in New Jersey. The company's $120 million commitment is for basic research, a spokesman said, and will include $20 million for a new research building and $100 million for new staff and other expenses. A current research staff of about 80 will be joined by 50 scientists and technicians. The 1987 research budget is about $15 million, with some $4 million spent on clinical research. The spokesman said that Merck Frosst's expanded research will be in the areas of "cures for allergies and respiratory ailments such as asthma and hay fever; inflammatory diseases such as arthritis; and skin diseases such as psoriasis." Glaxo Canada, a subsidiary of British Glaxo Holdings P.L.C., has made a commitmnet of $55 million for "basic research on the central nervous system, therapies for schizophrenia, migraine headaches, respiratory diseases and further development work in gastrointestinal and ulcer therapy." Glaxo plans to build a basic research unit at an as-yet undetermined site, to create about 100 jobs over the next five years and to hire a research director within the next several months. A spokesman said the plans were incomplete because of the recent passage of the new drug bill. Glaxo conducts all levels of clinical research but no basic research in Canada. According to Erola, the commitments represent new research money. She said multinationals plan their research budgets globally and allot funds to various facilities around the world. Canada has traditionally been considered an excellent place to do research, she said, because it has the appropriate infrastructure, educational standards and regulatory system and moderate costs. The only reason more research was not done in the past, she said, was the perception of a hostile environment. In the wake of the new bill, Erola said, the PMAC has been working feverishly to set up structures to carry out the research. A former Cabinet minister in the Liberal government, she acknowledged that the industry's actions will be under "intense scrutiny" by the public and govemment. Many observers are worried about higher drug prices; last month the Ontario government reported that prices for almost half the drugs sold in the province had risen faster than the consumer price index in the last six months. The PMAC has pledged to hold prices even with inflation, and the industry will continue to report annually to the Drug Price Review Board. A crucial part of its performance will be its R&D spending. A Cabinet committee will review the situation in four years, and a committee of Parliament will do likewise after a decade. Spurgeon is a freelance writer in Ottawa.

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