In the face of fast-paced technological advances in health and medicine, the field of law and policy seems to be stuck in a never ending game of catch up. Yet can the law really ever catch up? What are some of the important issues around law and new health and medical technology?

It was a full day packed with a diverse array of topics in health law and policy on the second day of the Canadian Conference on National Health Law entitled "Visions," by the University of Alberta's Health and Law Institute.

The overall theme was the "new," in terms of emerging research challenges, liability issues, technologies and paradigms in health law.

Emerging Research Challenges

Professor Trudo Lemmens, Associate Professor at the University of Toronto, Faculty of Law, opened the morning session with a discussion of Genetics and Health Information Privacy. He noted, hot on the heels of emerging new technologies in the field of genetics, the call for "openness" — a familiar rallying call by both scientists engaged in research and development (R&D), industry pundits and corporations.

"Biobanks" — which are literally stores of genetic information (The Human Genome Project is one popular example) — are increasingly being advocated as part of "publicly available" information.

"Biobanks" — which were in their inception aimed at facilitating the better understanding of gene interaction (with other genes and given environments) — now sit in the middle of the privacy conundrum simply because a variety of interests are pushing the limits on erstwhile taken for granted "informed consent" standards in both research and scientific treatment and experimentation. Yet even as the needs of R&D conflict with competing interests that range from individual privacy to public interests of access, Professor Lemmons noted how there continues to be a pressing need to guard against confounding which interests are invoked and who invokes them.

One interesting case study regarding a patent on breast cancer genetic data and testing methods in relation to it came from the work of Richard Gold of the Center for Intellectual Property Policy.

Myriad, a company which secured a patent over the testing technology as well as the genetic data, which was otherwise unchallenged in the US, ended up "in the eye of the policy storm," said Gold, when it attempted to market its tests in Canada.

While claiming the company did not choose to restrict R&D at all by making their information publicly available, its business plan included marketing a $3000 initial test for a genetic pre-disposition to breast cancer, and keep testing restricted to their Utah facility (requiring all material to be kept there). A cheaper follow up test available to the patient's other female relatives was licensed out to partner facilities.

Yet unlike the US, Canada raised several issues regarding the patent specifically with regard to the nature of the patents. For one, the scope of the patent (over the genetic data) was put into question. In what Gold characterized was also compounded by issues of "lack of trust," subsequent reactions by Myriad which included among others, cease and desist orders to those using their patented data in R&D, a confrontational stance in asserting Intellectual Property Rights and finally as a coup de gras, delivering to the Minister of Health, a set of strongly worded messages from US pharmaceutical corporations alongside a threat of US sanctions for failure to recognize Myriad's IPR in question, began a controversy which was lapped up by the media.

Ironically, the European Union reaction was not much different from Canada which also called into question the validity of the patents and ended up only recognizing a narrow right over a specific type of genetic information/mutations from Jewish populations. In the end, the rest of Myriad's patent was unenforceable in EU as well.

Clearly, the legal issue of "intellectual property rights" regimes impacts hugely on the accessibility of medical and scientific technology. Commercial interests and R&D interests (public and private) are usually united on the issue of "openness" during the R&D phase. Sharing information encourages innovation, facilitates verification and cross checks by the scientific community.

At this point, it is usually the interest of individuals and subjects of trials, patients and relatives who share common genetic material with subjects who come in conflict with "openness" paradigms. What does losing control of one's own genetic material mean for individual privacy? While R&D standards of consent are in general traditionally more stringent than actual practice in medical and health treatment interventions, doubts have always been raised about how realistic informed consent is. Biobanks either do not fully disclose the full range of applications for gathered genetic material nor do they always know beforehand what all the possible applications are.

In 2003, the World Health Organization itself expressed doubts about the effectiveness of "open blanket consent" models especially without a guarantee of anonymity.

On the other hand, at the point of invention and innovation, when issues of patentability arise, the discussion shifts somewhat and an altogether new set of issues arise. Ownership and control issues in the area of IPR have always been a problematic area and are usually the most contested site in cases of equity, justice and fairness. In the case of Myriad for instance, its insistence that it never intended to actually use its IPR on the genetic information to limit and inhibit breast cancer R&D and in fact sought to prove this by publicly making their data available to the public, its other acts have actually caused a chilling effect in the scientific community.

To be sure, different courts in different jurisdictions have decided differently. Prof. Lemmens noted how in US examples, patents got upheld in the face of claims by owners of genetic material to future commercial applications of their genes. The courts have upheld that there is no such right by the donor. Indeed a variety of legal fora and mechanisms was also acknowledged as severely limited in addressing a variety of situations that ranged from legal and ethical to medical and technological issues. In the end Prof. Lemmens noted that we need to take a second look at the promise of fixing "broken health care systems" through the speeding up of R&D and the "openness philosophy." Who is making this promise? Bringing ground breaking treatments faster to "the market" is not the same as actually bringing them to patients who need them the most.