Canada/US: Competition Bureau will not investigate GSK efforts to stop cross-border sales by internet pharmacies

On 21 March 2003, the Competition Bureau of Canada announced it would not proceed against GlaxoSmithKline (GSK) for its actions to block Canadian-based internet pharmacies from exporting medicines to the United States.     

UK Commission concludes international patent laws hinder access to medicines in developing countries

On 12 September 2002, the UK Commission on Intellectual Property Rights, an independent body established in May 2001 by the British government, released its report analyzing the impact of international agreements on patents. The report, Integrating Intellectual Property Rights and Developmental Policy, makes 55 recommendations "aimed at aligning [intellectual property] protection with the goal of reducing poverty".     

Honduras: government intimidates people with HIV/AIDS asserting right to medicines

In August 2002, the Honduran Ministry of Health violated the human rights of four Hondurans living with HIV/AIDS by releasing their names to a national newspaper.     

Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada

Advances in pharmacogenomic research and increasing industry interest in personalized medicine have important implications for the way that orphan drug policies are interpreted and applied. Concerns have been raised about the potential impact of pharmacogenomics and new genomic technologies on our understanding of how disease categories are delineated, and subsequently, how the concept of rare disease should be defined for the purposes of orphan drug policies. This article considers whether orphan drug legislation can be drafted in a way that will maximize benefits and minimize concerns relating to the impact of pharmacogenomics on orphan drug research and development. After reviewing the issues that may arise at the intersection of orphan drug policies and pharmacogenomics, this article will discuss the potential impact of pharmacogenomics at two critical points: orphan designation and approval of the drug product. At each of these points, the relevant aspects of current US orphan drug legislation are examined, focusing on the extent to which recent amendments may address concerns that have been raised previously. This analysis will then provide the foundation for a critical review and recommendations regarding the proposed new Canadian orphan drug framework.     

Canadian students join struggle for access to treatment

Canadian students have joined the struggle for global access to treatment. This article describes initiatives at McGill University and the University of Toronto.     

Global access to treatment: achievements and challenges

As mentioned in the previous issue, this section of the Review addresses issues related to improving access to adequate and affordable care, treatment, and support everywhere. It replaces the section previously called "Patents and Prices." In this issue, we feature a review of achievements and challenges in recent years in opening global access to HIV/AIDS treatments. The article - one of a series commissioned to mark the tenth anniversary of the Canadian HIV/AIDS Legal Network, discussing past developments and future directions in areas of policy and law related to HIV/AIDS - describes the developments that recast the debate about access to treatment from one focused on patent entitlements to one focused on the right to health and treatment. It analyzes the role of national and international activism, strategically constructed alliances, and principled leadership in achieving this change. And it discusses continuing obstacles to equitable access to HIV/AIDS treatments for the world's population.     

US patent infringement statute extends to the international market for copies of US software

In a patent infringement action involving the internationaldistribution of Microsoft's Windows software, the United StatesCourt of Appeals for the Federal Circuit has interpreted USpatent statute 35 USC section 271(f) as extending infringementliability to foreign computers assembled with copies of softwarereplicated abroad from a US-made master version.     

UK: Hemophiliac wins access to recombinant factor VIII

On 17 July 2003, the England and Wales High Court granted a hemophiliac leave to appeal a decision to refuse to provide him with recombinant factor VIII, a treatment for hemophilia not derived from human blood. The applicant had been infected with HIV and hepatitis B, C, and G through tainted blood products.