PharmacoEconomics & Outcomes News 395 - 18 Jan 2003

Future of pharmacotherapy about more than just money– Cameron Johnston –

If events over the past few years are any indication, it may well be that the future of pharmacotherapy is playedout as much in the courts and in the halls of government as it is in physicians’ offices, hospital rooms or researchlaboratories. At the Patented Medicines Pricing Review Board symposium held at the end of 2002 in Ottawa,Canada, Mr Tim Caulfield from the Health Law Institute, Edmonton, Canada, painted a complex, and sometimesless than attractive, picture of the future of pharmacotherapy.

Although the future might herald a brave new world of rather than serving as public institutions where learningbetter treatments for more diseases, achieving that goal is shared, will cease to function for the public good.might mean international legal battles over patented Cost an everpresent issuegenes and fundamental changes in the way basic Of course, no matter what new therapies are in theresearch is conducted at the university level. And of pipelines or how beneficial they might seem to an agingcourse there is the question of money, since new world population, cost is an issue that will not go away.developments are going to become more costly in time, In Canada, only slightly more than 30% of all drug costsand governments and insurance companies will not are covered by any kind of government programme, so aalways be willing to foot the bill for these new scientific growing issue concerning these therapies is sure to beinitiatives. whether the patient has private insurance, or whetherThe intellectual property debate some form of government-sponsored drug plan will

Mr Caulfield said that, while in the future, illnesses cover drug costs. According to Mr Caulfield, there arewill be diagnosed faster and more precisely and treated now approximately 35 000 DNA-based patentswith drugs that are more targeted to the particular worldwide, an increase of more than 10 000 singlepathogens – so-called ‘designer’ or targeted therapies – patents since 2001. Future medical research, as well asmany of these drug discoveries will hinge upon future medical technologies, will have to tread carefullyknowledge of genetics and the ownership of intellectual around the issue of who owns these patents and whatproperty. A well-publicised legal/ethical conundrum that ownership means to healthcare systems. "Thisconcerns an American company Myriad Genetics, which emerging commercialization will necessitate policyholds the patent for the two genes known to be changes on the part of the Canadian healthcare system,associated with breast cancer (BRCA1 and BRCA2). The but [fluctuations in international exchange rates] willcompany maintains that any and all testing for breast also make it more difficult for Canadians to access somecancer that uses these genes infringes upon its patents, of these technologies," he said. "We as a society need toand has launched court actions against physicians, understand the role of patents and gene patenting on ourinstitutions and diagnostic laboratories that have economy. We need to have more research on the risksattempted to use this technology. The Canadian and benefits of gene patents and gene therapies, and weprovince of Ontario has set up its own diagnostic need a system for mediating our policy options," he said.laboratory to perform these tests, saying that at Genetic testing likely to increase costs$Can3800 per test,* it is too costly to send specimens to The emerging trend in pharmacogenomics will alsoMyriad for diagnosis. Ontario appears set to confront entail significant costs, as healthcare payers insist thatMyriad in court over the issues of patent infringement, patients be genetically screened before receiving athe public good, and the right to patent a gene. particular drug or treatment. Such genetic testing mayPush for knowledge that can turn a profit also lead to ‘pre-emptive strikes’ against diseases that

"The government is encouraging gene patenting, but have not yet taken hold, but for which a patient carries athen they don’t want to pay for this testing [the Myriad particular gene. This ‘customisation’ is certain tocase]", Mr Caulfield said. This is far from being the only increase costs significantly because the potential marketcase where a government appears to contradict itself, he size for every new product will be reduced. Each drugadded. Universities and other investigators are recipient will have to bear a proportionately higherencouraged by governments to pursue the latest and percentage of the overall development costs. This raisesgreatest in genetics research, and governments legal issues as to whether a person’s genetic make-upwholeheartedly support these institutions making should be kept confidential, between the patient and themoney; as long as they act as if this knowledge should diagnostic laboratory, or whether the informationbe in the public domain, it seems hypocritical for them should be shared with healthcare professionals,to espouse the idea of intellectual property. At the same insurance companies and employers under certaintime, one can argue that a government operating with circumstances.tax-payers’ money should not be encouraging scientists The use of such information will force major changesor healthcare professionals to break existing patent laws. in patent legislation and will mean the industry, researchOwnership of genetic patents, in fact, may challenge the institutions, governments and private insurers will havefundamental raison d’etre of universities as centres of to draw up new predictive models to outline howscientific research. Rather than focusing on basic potential "populations at risk" should be managed, saidresearch, Mr Caulfield said there is now a push for Dr Steve Morgan from the Canadian Institute for Healthuniversities to pursue research that leads to patentable Services and Policy Research at the University of Britishresults – i.e. knowledge that can turn a profit. New Columbia. Dr Morgan pointed out that retail spendingdiscoveries will become closely guarded secrets, on prescription drugs in Canada has doubled over theavailable only to those who have the money to afford past 5 years, although the number of prescriptions beingthem, while universities conducting such research, written has not; no single market for prescription drugs

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Future of pharmacotherapy about more than just money - continued– continued

and no particular innovation has yet been identified as much public and scientific attention, but the Canadianthe primary driver of these cost increases. market accounts for only 2% of the world market overall.

Therefore, Canadian companies are forced to search theMore costly products to become standardworld’s markets for whatever drugs they have underFrom the viewpoint of pharmaceutical companies, development. In addition, the size of the Canadianmore costly products will definitely become the rule market also means Canada is linked inextricably – oftenrather than the exception. President of Aventis Pasteur as junior partner – with the rest of the world in anyLimited, Canada, J Mark Lievonen said drugs such as discussion over the future of pharmacotherapy. The‘Varivax’, ‘Prevnar’ and ‘Menjugate’, which cost issues that concern Canada in this debate may also$Can50–$Can70 per dose, incurred research and affect other countries, to a greater or lesser degree.development (R&D) and manufacturing costs of Given that this is primarily a medical-scientific issue, it is$Can600 million–$Can700 million each, and therefore an unfortunate reality that the legal profession is eager totheir higher price is justified. Also, he said, newer drugs get involved, making the practice of medicine in sometake much longer to develop (10–15 years, on average), countries even more of a legal minefield than it alreadyso there is a shorter time period under which they are is. Perhaps a more appropriate term for this futurecovered by patent protection; therefore, development aspect of healthcare might be pharmaco-legal-and discovery costs will have to be recouped in a much therapeutics.shorter timeframe. Moreover, even in the case of* Canadian dollarsexisting drugs, the costs of meeting regulatory

800888457requirements are still high, noted Mr Lievonen.Biopharmaceuticals is also an area that has captured

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