Leslie Dan Faculty of Pharmacy, Toronto, ON, Canada.
Global Health. 2012 Apr 3;8:7. doi: 10.1186/1744-8603-8-7.
The reform of pharmaceutical policy can often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a legislative amendment that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only two orders of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda have been exported. Future use of the regime appears unlikely. This research aimed to examine the politics of CAMR.
Parliamentary Committee hearing transcripts from CAMR's legislative development (2004) and legislative review (2007) were analysed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analysed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR.
In 2004, policy debates in Canada were dominated by two themes: intellectual property rights and the TRIPS Agreement. The right to medicines as a basic human right and CAMR's potential impact on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by experience in implementing the legislation and hence a greater representation of the interests of potential beneficiary country governments.
The Canadian Government designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access.
药品政策改革往往涉及到相互竞争的社会和商业目标之间的权衡取舍。加拿大的《药品获取机制法案》（CAMR）是一项立法修正案，允许对药品的生产和出口实行强制许可，以惠及发展中国家，旨在调和这些目标。自 2004 年通过以来，仅向卢旺达出口了足够 21000 名艾滋病毒/艾滋病患者使用的两种抗逆转录病毒药物。该机制的未来用途似乎不太可能。本研究旨在考察 CAMR 的政治背景。
对 CAMR 立法发展（2004 年）和立法审查（2007 年）的议会委员会听证记录进行了分析，使用内容分析技术来识别参与辩论的利益相关者如何构建问题。随后使用框架、机构和利益的框架对这些发现进行了分析，以确定这三个维度如何塑造 CAMR。
2004 年，加拿大的政策辩论主要围绕两个主题：知识产权和《与贸易有关的知识产权协定》（TRIPS 协定）。药品作为基本人权的权利和 CAMR 对创新的潜在影响几乎没有被讨论。以加拿大工业部和国际贸易部为主要机构，保护知识产权和确保与美国保持良好贸易关系的目标似乎优先于鼓励通过仿制药竞争来实现药品的可负担性。结果是对 WTO 第 6 节决定下专利灵活性的解释更为有限。最引人注目的发现是，对发展中国家受益方在试图利用强制许可时可能面临的潜在障碍几乎没有讨论，包括它们不愿利用 TRIPS 灵活性、它们希望追求技术发展以及 WTO 第 6 节决定固有的限制。相反，这些问题在 2007 年被提出，这在一定程度上可以归因于实施立法的经验，因此潜在受益国政府的利益代表更多。
加拿大政府将 CAMR 设计为最后手段。增加发展中国家受益方的投入，并转向将健康权优先化的机构，可能会导致制定出更好地实现负担得起的药品获取的政策。
