Health Law

Reports abound of an apparent innovation crisis in the pharmaceutical sector, with some sources citing escalating drug development costs, declining new drug approvals, and an increasingly stringent regulatory environment. Concurrently, commentators refer to the death, or at least the decline, of the blockbuster model of drug development—where large, brand-name pharmaceutical companies rely on a portfolio of drugs that gross more than U.S. $1 billion per year—which has dominated the pharmaceutical sector for decades.

Decreasing the Data Deficit: Improving Canada’s Drug Regulatory System: Paper by Trudo Lemmens & Shannon Gibson now publicly available on SSRN.

Ontario’s new Minister of Health Eric Hoskin argued in a recent Toronto Star op-ed article for a national pharma plan as an essential component of equitable health care. Federal Health Minister Rosa Ambrone appears also supportive of exploring the development of such a plan. The arguments in favour, based on equity and cost containment, are strong. The development of such a plan will only increase the need to ensure the production of reliable drug safety and effectiveness information. Shannon Gibson and I discuss in a recent paper in the OUP journal Medical Law Review (Shannon Gibson & Trudo Lemmens, "Niche Markets and Evidence Assessment in Transition: A Critical Review of Proposed Drug Reforms" (2014) 22(2) Med. L. Rev. 200-220 available online here for people with UofT library access; and here in a pre-print version on SSRN), how the development of niche pharmaceutical products for which often exorbitant prices are being charged, creates additional pressure to adjust existing drug regulatory and funding systems. As pharmaceutical development strategies evolve and drug products become more complex, regulatory and policy responses must be able to evolve along with them.