E-DRUG: What is the impact of IP rules on access to medicines? A
systematic review.
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This recently published systematic review might be of interest to e-druggers.
Please find the open access article here
https://globalizationandhealth.biomedcentral.com/articles/10.1186/s12992-022-00826-4
Suggested citation:
Tenni, B., Moir, H.V.J., Townsend, B. et al.
Global Health 18, 40 (2022). https://doi.org/10.1186/s12992-022-00826-4
Abstract
Background
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.
Methods
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.
Results and conclusion
Five broad overarching themes and 11 sub-themes 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
licensing 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.
Brigitte Tenni
Brigitte Tenni
Senior Technical Advisor
Nossal Institute for Global Health,
The School of Population and Global Health
The University of Melbourne Australia
btenni@unimelb.edu.au