# \[e-drug\] What is the impact of IP rules on access to medicines? A systematic review.

**URL:** https://talk.edrugplus.org/t/e-drug-what-is-the-impact-of-ip-rules-on-access-to-medicines-a-systematic-review/46816
**Category:** e-drug
**Created:** [April 20, 2022, 5:37am UTC](https://talk.edrugplus.org/t/e-drug-what-is-the-impact-of-ip-rules-on-access-to-medicines-a-systematic-review/46816 "2022-04-20T05:37:17Z")
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### Author: ![Brigitte\_Tenni](https://avatars.discourse-cdn.com/v4/letter/b/e9bcb4/32.png) [@Brigitte\_Tenni](https://talk.edrugplus.org/u/Brigitte_Tenni)
#### Post date: [April 20, 2022, 5:37am UTC](https://talk.edrugplus.org/t/e-drug-what-is-the-impact-of-ip-rules-on-access-to-medicines-a-systematic-review/46816/1 "2022-04-20T05:37:17Z")

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E-DRUG: What is the impact of IP rules on access to medicines? A  
systematic review.  
----------------------------------------------------------------------------

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](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](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