人们普遍认为,专利和数据独占性等知识产权法律要求会影响药品的获取,但是到目前为止,还没有对这个主题的经验证据进行全面的审查。世界贸易组织的《与贸易有关的知识产权协定》(TRIPS)要求成员国实施知识产权保护的最低标准,包括药品专利,但也包含旨在解决获取药物障碍的“灵活性”。国家知识产权法还可以包括超出TRIPS要求的TRIPS-plus规则。我们旨在系统地回顾衡量知识产权规则对药品获取影响的文献,是否作为TRIPS的结果实施,其他贸易协定中的TRIPS-plus条款,或单方面的政策决定。
我们搜索了Proquest,Scopus,WebofScience,PubMed,JSTOR,Westlaw和LexisNexis.同行评审的文章,包括政府报告和其他灰色文献。如果文章是定量的,它们有资格被纳入,在英语中,包括成本的衡量标准,价格,药物的可获得性或可获得性,是关于知识产权或数据独占性规则的,于1995年1月至2020年10月期间发布。91项研究符合我们的纳入标准。我们系统地回顾了研究结果,并使用改进的质量评估模板评估了其质量。
根据文章的重点,确定了五个广泛的总体主题和11个子主题。它们是:贸易协定(分为欧盟自由贸易协定和包括美国的自由贸易协定);TRIPS灵活性的使用(分为强制许可和平行进口);专利到期/通用进入/通用途径(分为比较研究和单一国家研究);专利政策(也分为比较研究和单一国家研究)和TRIPS-plus规则(分为数据独占性,专利期限延长和二次专利)。大多数研究不关注具体的贸易协定,但在TRIPS-plus条款上,这也可以在一些贸易协定中找到。这篇综述的主要发现是,TRIPs-plus知识产权规则所造成的更强的药品垄断,一般与药品价格上涨有关,延迟了可用性,增加了消费者和政府的成本。有证据表明,TRIPS的灵活性可以促进药物的获取,尽管迄今为止药物的使用有限。很少有研究包括资源匮乏的环境,这表明需要在对获得药物的影响可能更具破坏性的环境中进行更多的研究。
It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive
review of the empirical evidence on this topic. The World Trade Organization\'s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains \'flexibilities\' designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically
review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions.
We searched Proquest, SCOPUS, Web of Science, PubMed, JSTOR, Westlaw and Lexis Nexis. Peer reviewed articles, government reports and other grey literature were included. Articles were eligible for inclusion if they were quantitative, in English, included a measure of cost, price, availability of or access to medicines, were about intellectual property or data exclusivity rules and published between January 1995 and October 2020. Ninety-one studies met our inclusion criteria. We systematically reviewed the studies\' findings and evaluated their quality using a modified quality assessment template.
Five broad overarching themes and 11 subthemes were identified based on the articles\' foci. They were: trade agreements (divided into EU FTAs and those that include the USA); use of TRIPS flexibilities (divided into compulsory licencing and parallel importation); patent expiry/generic entry/generic pathway (divided into comparative studies and single country studies); patent policies (also divided into comparative studies and single country studies) and TRIPS-plus rules (divided into data exclusivity, patent term extensions and secondary patenting). Most studies focused not on specific trade agreements, but on TRIPS-plus provisions, which can also be found within some trade agreements. The main finding of this
review is that the stronger pharmaceutical monopolies created by TRIPs-plus intellectual property rules are generally associated with increased drug prices, delayed availability and increased costs to consumers and governments. There is evidence that TRIPS flexibilities can facilitate access to medicines although their use is limited to date. There were few studies that included resource poor settings, signalling a need for greater research in such settings where the impact on access to medicines is likely to be more damaging.