Bulletin of the World Health Organization

Patent pooling to increase access to essential medicines

Esteban Burrone a, Dzintars Gotham a, Andy Gray b, Kees de Joncheere c, Nicola Magrini d, Yehoda M Martei e, Charles Gore a & Marie Paule Kieny a

a. Medicines Patent Pool, 7 Rue de Varembé, 1202 Geneva, Switzerland.
b. Division of Pharmacology, University of KwaZulu-Natal, Durban, South Africa.
c. Netherlands Antibiotic Development Platform, University Medical Centre, Utrecht, Netherlands.
d. Essential Medicines and Health Products Department, World Health Organization, Geneva, Switzerland.
e. Hematology-Oncology Division, University of Pennsylvania, Philadelphia, United States of America.

Correspondence to Esteban Burrone (email: eburrone@medicinespatentpool.org).

(Submitted: 29 December 2018 – Revised version received: 22 April 2019 – Accepted: 26 April 2019 – Published online: 11 June 2019.)

Bulletin of the World Health Organization 2019;97:575-577. doi: http://dx.doi.org/10.2471/BLT.18.229179

Access to medicines is key to achieving universal health coverage (UHC); however, such access can be hindered by unaffordable prices. A good example of improvement in access to medicines is treatment for human immunodeficiency virus (HIV) infection. Global coverage was very low in 2000, with only 611 000 people receiving treatment; however, in 2017, 21.7 million people were on treatment.1,2 This increase was partly due to access to affordable, quality-assured generic HIV medicines in low- and middle-income countries.1

One way to achieve better access to new medicines is patent pools, which allow third parties to acquire non-exclusive licences for the intellectual property needed to develop products. While patent pools have existed for several decades in other fields of technology, such as in digital technologies, they are a relatively new concept in public health, where they have been applied to address some of the access challenges in low- and middle-income countries.3

To improve access to antiretroviral treatment in low- and middle-income countries, Unitaid established the Medicines Patent Pool in 2010 as the first public health patent pool. Later, the patent pool’s mandate was expanded to treatments for tuberculosis and hepatitis C. The patent pool has negotiated most of the licensing agreements with pharmaceutical companies that have enabled competitive generic manufacture of antiretrovirals in low- and middle-income countries before patent expiry. These licences have also facilitated the development of new formulations that are particularly needed in resource-constrained settings, such as certain fixed-dose combinations and paediatric formulations. To date, the patent pool’s generic partners have distributed 22 million patient-years of treatment, allowing global savings of 1.06 billion United States dollars (US$), according to a biannual analysis undertaken by a leading auditing company.4

In 2016, the Lancet Commission on Essential Medicines Policies, the World Health Organization (WHO) and other stakeholders called for the patent pool to expand its mandate to a broader range of patented essential medicines.5,6 Here, we outline the findings of a released feasibility study on expanding the patent pool’s mandate,7 laying out the public health case for adapting its model to disease areas beyond the initial three focus diseases. In May 2018, the patent pool acted on the results of the feasibility study and expanded its mandate to include other patented essential medicines.

Essential medicines

WHO’s Model list of essential medicines comprises medicines that meet the priority health needs of the population and that should always be available and affordable in all countries. WHO’s model list is updated every two years by the Expert Committee on the Selection and Use of Essential Medicines, which considers submissions based on public health relevance, efficacy, safety and comparative cost–effectiveness.8

Competitive generic manufacture could lead to significant price reductions for patented essential medicines in low- and middle-income countries. Such reductions have recently taken place for certain oncology medicines following patent expiry and generic market entry. For example, in South Africa, the price of a leukaemia medicine on WHO’s model list has decreased by 98.5% since 2012, to US$ 400 per patient per year in 2019, following generic market entry.9,10 Therefore, public-health-oriented licensing could contribute to price reductions for other essential medicines that are still under patent protection in low- and middle-income countries.

The feasibility study identified various categories of patented medicines for which public health-oriented licensing could be an important strategy to improve access (Table 1). These categories include patented medicines on WHO’s model list and others that have received favourable clinical assessments by the expert committee. We analysed relevant epidemiology, treatment landscapes, market sizes and pricing in low- and middle-income countries, supplemented with case studies from several countries to better understand local contexts.7 As patents are granted at the national, or regional level, and patent status (that is, whether a drug is protected by patents) can vary significantly between countries, we also undertook an analysis of the patent landscape in a sample of low- and middle-income countries.7 Finally, we looked at the potential impact of the patent pool’s expansion, the possible challenges in ensuring that licences result in increased access and possible ways of addressing such challenges.

Based on assessments made by WHO’s expert committee, the feasibility study identified five categories of products that could be potential candidates for licensing via the patent pool. These categories are: (i) patented medicines included in WHO’s model list; (ii) patented medicines that are not yet included in the list, in part due to insufficient cost–effectiveness at current prices; (iii) patented medicines that show promising clinical data and may merit inclusion in the list in the future if clinical benefit is confirmed; (iv) patented cancer medicines that require further review; and (v) new patented antimicrobials (Table 1).

The patent pool’s current focus is primarily on small-molecule medicines, rather than biotherapeutics, as further analysis is required to better understand the potential for patent pooling to contribute to affordable access to biotherapeutics.

Early licensing

The patent pool’s model contributes to accelerating affordable access to new, improved treatments in low- and middle-income countries in partnership with the pharmaceutical industry. To achieve this goal in HIV, licensing arrangements for new medicines considered promising by WHO has sometimes been necessary before their inclusion in WHO’s model list, as in the case of dolutegravir. The patent pool signed a licensing agreement with a pharmaceutical company for dolutegravir in 2014. By the time the medicine was added to WHO’s model list in 2017, several patent pool sub-licensees had filed for approval of generic versions, including a new fixed-dose combination, with the WHO prequalification programme.

Under an expanded mandate, the patent pool will work in partnership with WHO and other key stakeholders to identify promising medicines for which agreements with patent-holders can be established early, to accelerate access to important new treatments in low- and middle-income countries.

Challenges and opportunities

As the patent pool begins work in new disease areas, several challenges could arise, such as constrained health systems and limited diagnostic capacity in many low- and middle-income countries, particularly in relation to certain cancers. Another challenge is the lack of large, international donors for scaling up treatments and contributing to the introduction of new products outside the domains of HIV, tuberculosis and malaria. This challenge has already been encountered in hepatitis C, where uptake of products licensed by the patent pool was initially limited to the private market due to the lack of large viral hepatitis treatment programmes. However, more recently, government treatment programmes have begun to be established in certain low- and middle-income countries in the context of broader national strategies on viral hepatitis, partly thanks to access to more affordable medicines.

Governments and global health actors are increasingly recognizing the need for expanded treatment programmes for noncommunicable diseases. Political commitments at the recent United Nations high-level meeting on noncommunicable diseases will need to be followed by robust action to attain UHC. Access to affordable treatments can contribute to the development of public health programmes, including for more active screening and diagnosis. Greater availability and affordability of improved treatments with greater efficacy, easier administration, lesser side-effects or less monitoring requirements can also contribute to reducing health systems costs (Table 1).

The work of the patent pool takes place in the wider context of various policies, instruments and initiatives that can contribute to addressing the challenges in making essential medicines available, affordable and accessible in resource-constrained settings. Patent pooling is one way of contributing to the affordability of products and over the years, governments have taken different approaches to ensuring affordable access to medicines. Approaches have included price negotiations, health technology assessments, reference pricing, new procurement models such as a subscription model and the use of flexibilities under the Agreement on Trade-Related Aspects of Intellectual Property Rights. For patent pooling to succeed in new areas, the patent pool will need to work closely with various partners, particularly governments, to explore other barriers to access and to facilitate uptake of products licensed by the patent pool.

Public health-oriented patent pooling has become a proven access strategy since the establishment of the patent pool. In our feasibility analysis, we found that licensing through the patent pool could offer significant public health impact. In many low- and middle-income countries, some of the newer medicines for noncommunicable diseases are not available, not registered or used only by a small proportion of the population, mostly in the private market, with significant out-of-pocket payments. Licensing through the patent pool could potentially accelerate access to improved treatments in countries that might not be considered as significant commercial markets. Suitable royalty provisions could provide adequate compensation to patent holders, while enabling access to lower-priced alternatives.

As a next step, the patent pool is working closely with WHO and other key stakeholders to develop a robust framework for identifying priority medicines where a patent pooling model could have the greatest public health impact and enable wider access to essential medicines in low- and middle-income countries.


Acknowledgements

We thank our colleagues at the Medicines Patent Pool.

Funding:

The feasibility study was funded by a grant from the Swiss Agency for Development and Cooperation.

Competing interests:

EB and CG are employees of the Medicines Patent Pool. DG and YM serve or have served as consultants to the Medicines Patent Pool. AG was a co-chair of the Lancet Commission on Essential Medicines Policies and chairs the Proposal Review Committee of Unitaid. He is a member of the WHO Expert Panel on Drug Policies and Management. KdJ was Director of the Department of Essential Medicines and Health Technologies at WHO, when WHO suggested to the UN High-Level Panel on Access to Medicines that the scope of Medicines Patent Pool be expanded to include other patent-protected essential medicines; he was also member of the Lancet Commission on Essential Medicines. KdJ also serves as the Vice-Chair of the Expert Advisory Group of the Medicines Patent Pool. MPK is the Chair of the Board of the Medicines Patent Pool. NM is the Secretary of the Expert Committee on the Selection and Use of Essential Medicines. NM, KdJ, AG and YM served as members of the Medicines Patent Pool feasibility study Steering Group.

References