MOHAMMAD SHAHZAD, Universities Allied for Essential Medicines (UAEM)

Lead Author: Mohammad Shahzad
Additional Author(s): Thi-Yen Nguyen, Juliana Veras, Rachel Kiddell-Monroe
Organization: Universities Allied for Essential Medicines (UAEM)
Country: Canada, Netherlands, France

Abstract

Intellectual property (IP) management at universities and public research institutions (PRIs) has the potential to enable or restrict access to university-derived health technologies in all countries, but most notably low-resource settings. Today, universities own patents on nearly one in five drugs and are an indispensable part of the biomedical R&D process. Given their fundamental role in research as well as their responsibility to prioritize public interests in research and innovation, policy incentives for licensing of technologies derived from universities and PRIs must actively promote, and not restrict, access to health.

To address the incoherence that can arise from misaligned policy incentives, UAEM strongly advocates for the adoption and implementation of Global Access Licensing (GAL) policies at universities and PRIs. Having a GAL policy will allow universities and PRIs to incorporate access provisions in licensing agreements with industry partners to ensure access to the end product in low-resource settings. This is in contrast to socially responsible licensing - a broader set of approaches including attempts to safeguard access to the end product - which UAEM believes is insufficient for achieving global access of health technologies derived from universities and PRIs.

In order to assess how universities and PRIs can best manage their IP in accordance with public health objectives, UAEM recently conducted a survey of experiences in policy implementation of GAL in selected universities. Through interviews with licensing officers at technology transfer offices (TTOs) of universities including Harvard, Yale, and Oxford, we highlight specific GAL provisions utilized by these TTOs in licensing agreements to ensure global access of their health technologies.

UAEM recommends that the High Level Panel urges implementation of GAL policies at universities and PRIs, sharing of best practices among universities and PRIs, and development of adequate metrics of global health impact for licensed technologies resulting from publicly-funded research.

Submission

Submission to the UN High Level Panel on Access to Medicines (Submitted by Universities Allied for Essential Medicines)

Adoption of Global Access Licensing at Universities and Public Research Institutions



Summary

Universities Allied for Essential Medicines (UAEM) urges the High Level Panel to prioritise implementation of policies to ensure Global Access Licensing (GAL) of health related discoveries in universities and public research institutions (PRIs). This will be a key element in achieving the 2030 Agenda for Sustainable Development and, in particular, Sustainable Development Goal 3: to improve health and well-being for all. Given their fundamental role in research as well as their responsibility to prioritize public interests in research and innovation, universities and PRIs must seek policy incentives which actively promote, not restrict, access to medical technologies in low-resource settings.

Introduction

Dear Members of the UN High Level Panel on Access to Medicines,

UAEM welcomes the opportunity to make a submission on “Adoption of Global Access Licensing at universities and public research institutions”, to support the attainment of Sustainable Development Goal 3 and the 2030 Agenda for Sustainable Development.

As a student-led movement anchored in universities and PRIs worldwide, UAEM promotes global access to health innovations, notably through local and global advocacy for the implementation of GAL policies within universities and PRIs. We work to ensure that licensing of health-related technology is coherent with the social mandate of the institution, ensuring that products originating at universities make their greatest impact worldwide.



1. Background: Addressing the policy incoherence

In order to guarantee the fulfilment of the right to health, WHO member states have recognized the urgent need to scale-up global access to health technologies. In particular, Sustainable Development Goal 3 of the 2030 Agenda for Sustainable Development clearly states the need to "support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health." Despite major achievements in public health international provisions, national innovation policies are lagging behind in the creation of effective incentives to attain these goals.

Prevailing innovation policies, in some cases emulating the US Bayh-Dole Act of 1980, have historically addressed the problems of local competitiveness and economic growth by stimulating the creation of clusters of private product-development entities around universities(1), without considering their impact on future access to health products(2). The priority in this approach is the transfer of research advances to industry in order to create “spin-off” companies, high-revenue products, and investor returns.

National policies have encouraged universities to seek broad patent protection, while allowing them to establish internal policies on how to out-license rights to patented technologies, and allowing universities to have ownership of inventions resulting from publicly sponsored research(3). However, current legal frameworks pertaining to university Intellectual Property (IP) management do not address how IP should best be managed in order to protect public health.

University Technology Transfer Offices (TTOs) are relatively new entities arising from the Bayh-Dole (and similar) legislation. They play a crucial role in facilitating the translation of basic research into downstream health products through the management of licensing agreements with industrial partners. There is mounting pressure on TTOs to generate income, which is thought to have an impact on the way universities' IP is managed. Today universities own patents on nearly one in five drugs(4). In addition, a growing trend of competition among research institutions has pushed universities in the direction of IP maximalism(5).

Civil society and representatives of academia have extensively criticised current innovation policies. for example, they have said:

- current policies are ineffective in avoiding market failures to develop treatments for health problems that disproportionately affect developing countries(6);

- innovation policies have created incentives for universities "to develop independent technology transfer programs and to manage IP in a highly individualized and even competitive framework, with respect to other universities", not only increasing transaction costs and delays in making research inputs accessible, but also encouraging the "underutilization of proprietary technologies"(7);

- current policies and incentives have not been able to guarantee sustainable and affordable access to resulting health innovations(8);

- where they exist, measurement criteria to evaluate the social impact of current innovation policy incentives have been reduced to traditional, inadequate metrics such as numbers of patents filed, revenue obtained from licensed patents, and number of startup companies created to commercialize university IP(9);

- TTOs are encouraged to adopt strategies of patent licensing that maximize revenue, while neglecting how university-based IP can be best managed in order to maximize the social impact of research(10).

The Commission on Intellectual Property Rights, Innovation and Public Health(CIPH)(11), the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPoA)(12), and the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG)(13), have all stressed the importance of developing licensing strategies to promote the management of IP rights to prioritise public health. In line with these WHO recommendations, UAEM is committed to advocating for sustainable IP management strategies at universities to maximise social impact(14).



2. Global Access Licensing as part of the solution

a. The Principles

UAEM drafted the Global Access Licensing (GAL) framework to guide the design of patent licenses. It aimed to ensure rapid access to the end product in low-resource settings, with minimum administrative burden and maximum use of dynamic market mechanisms (i.e. generic competition) to reduce prices in these settings as quickly as possible(15).


GAL Framework:

Goals
1. Access to medicines and health-related technologies for all is the primary purpose of technology transfer of health-related innovations.
2. Technology transfer should preserve future innovation by ensuring that IP does not act as a barrier to further research.

Strategies
3. Generic competition is the most efficient method of facilitating affordable access to medicines in resource-limited countries.
4. Proactive licensing provisions are essential to ensure that follow-on patents and data exclusivity cannot be used to block generic production.
5. University technology transfer programs should facilitate future innovation by patenting only when truly necessary.
6. A global access licensing policy should be systematic in its approach, sufficiently transparent to verify its effectiveness, and based on explicit metrics that measure the success of technology transfer by its impact on access and continued innovation(15).

We define GAL as any license that satisfies the criteria set out in the GAL framework. On the other hand, we define ‘socially responsible licensing’ (SRL) as a broader set of approaches to IP licensing that includes any attempt to safeguard access to the end product. Such an attempt was made by Association of University Technology Managers (AUTM) in 2009, when they published their SRL principles; the Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies, along with six leading research universities in collaboration with UAEM. Today, it's endorsed by universities all over the world(14) In our view, some approaches to SRL, which are not compliant with the GAL framework, are inadequate(16). That being said, we've witnessed numerous examples of good attempts at SRL and we applaud institutions who commit to such SRL strategies. We recognize that these are not as sufficient as GAL, but they're important steps in the right direction.

b. University experiences with implementation of GAL

In January 2016, the World Health Organization (WHO) and the Institut Pasteur organized a workshop that addressed the role of academic research and public health institutions’ licensing policies in ensuring development, affordability and availability of new health products. UAEM contributed a survey of the management of IP in line with public health objectives at universities and TTOs focusing on the implementation experiences of universities that have adopted access policies with elements of the GAL framework(17). This survey explored:
- Principles of GAL activities at the universities;
- GAL provisions included in contracts negotiated by the TTO;
- Examples of university-derived health technologies licensed under GAL provisions;
- Challenges and monitoring of access policy implementation.

The UAEM survey concluded:
- Having an access policy in place at the university/PRI increases the ability for the TTO to include GAL provisions in negotiated license agreements;
- Information about implementation of access policies by TTOs is scarce, and specific metrics or formal evaluation of implementation are largely absent;
- Anecdotally speaking, greater experience of access policy implementation decreases the challenges TTO face in implementation (such as successfully overcoming doubts of the prospective licensee);
- Access policy implementation does not pose a significant threat to university income nor to securing eventual licensing of patented technologies(18).

The workshop focused on how IP licensing is managed by universities and PRIs and how this impacts access to new health products. In particular, the lack of information and guidance on GAL poses a barrier to progress in IP management strategies. In order to close this information gap, a more systematic analysis of existing practices is needed and TTOs can contribute by sharing their experiences(19).



3. Implementation of GAL

UAEM believes that universities and PRIs should adhere to principles of public research for the broader benefit of society and patients. Many universities and PRIs have recognized the importance of providing access to public research and resulting health-related products through their patenting and licensing practices. Below we give selected survey examples of how universities incorporate access considerations into their IP management.

1. Formal adoption of a GAL policy
By formally adopting a GAL policy or framework, universities and PRIs commit themselves and private partners to principles which must guide licensing negotiations for all medical and health-related technologies.

In our survey, several TTOs reported that having a formal global access policy in place increases their success in including access provisions in licensing agreements with industry partners(12).

“Having the UCL policy in place has greatly increased our ability to negotiate GAL principles [...] there was [...] great difficulty in securing any changes to the terms of existing licences in place before GAL principles were adopted” - University College London TTO


2. Contractual and specific licensing approaches
a. Term sheet: universities and PRIs can gain leverage in the negotiation process by defining GAL and introducing the concept of global access at the outset of negotiations with potential licensees(18)
"We discuss at the very beginning what types of global access provisions will be relevant and included in the discussion. If we have a term sheet, we will include them [global access provisions] on a higher level on that term sheet" - Harvard University TTO

b. Contractual Definitions: Definitions are an important part of the license agreement. Exhaustive definitions of terms such as geographical market areas and pricing greatly increase the potential efficacy of included provisions.


c. Global Access provisions:
Examples:
Due diligence requirements
“The licensee agrees to use Diligent Efforts to develop and commercially exploit licensed Products in a manner consistent with [ethical and socially responsible licensing principles]” - University College London TTO

March-in rights
"If the therapeutic is a compound that just needs to be made and our licensee isn’t making fast enough to meet the need, than you have stronger provisions that say, basically, we can bring someone else in to meet that need.” - Harvard University TTO

Limited patenting in developing countries
“...Discretion for Harvard to refuse to file or maintain Patent Rights in any Developing Country unless: (a) Licensee demonstrates that doing so would materially increase the locally-affordable availability of Licensed Products or equivalents thereof (e.g., generic products) in such country and (b) Licensee agrees that Harvard holds final decision-making authority re enforcement of such Patent Rights in such country.” - Harvard University TTO


Non-Suit obligation
‘licensee won’t file its own patents that would claim licensed products in those developing world territories’, but that’s a tall order to get into a licensing agreements – but one fallback that we’re often successful with is that they agree not to pursue infringers of those patents in developing world provided that the infringing activity is not intended to export the product back to a major market country” - Yale University TTO

Monitoring/reporting product development
"Every company that we enter into a license agreement with has to report no less frequently than annually on the development activities that they have undertaken” - University of British Columbia TTO

Marketing territories and pricing
“The Licensee shall use Diligent Efforts to supply the Licensed Products to customers in At-Cost Markets at a Cost-Based Price [and to meet market demand for the Licensed Products in those markets]” - University College London TTO


GAL is feasible for universities. Many of the same concerns are raised over and again by TTOs questioning the impact of introducing such policies. What we have seen and heard is that revenue generated from technology transfer practices at universities and PRIs does not constitute a significant source of university income. (Patent royalties comprise only 0.5-2% of total university revenue(20) and TTOs often do not break-even(21,22) ).

Furthermore, the economic realities of market segmentation for low- and middle-income countries (LMICs) support the position that adoption of GAL practices will not pose a threat to pharmaceutical sales or university royalties(20). LMICs represent a very small source of revenues and profits for pharmaceutical companies. PhRMA’s annual industry reports reveal that 93.2% of all total pharmaceutical revenues in the year of 2013 came from consumers in the US, Canada, Europe, and Japan(23).

Some TTOs are also concerned that parallel importation will allow technologies licensed under global access terms in LMICs to be be illegally diverted back to high-income countries (HICs)(17). However, there is no empirical data or evidence to suggest such flows of medicines and drugs from LMICs to HICs(24). Furthermore, this potential concern can be addressed in the licensing agreement through steps taken by the WTO: requiring use of different packaging, pill color, and pill shape to facilitate identification of illegal importations, where this is feasible and does not significantly increase the price of the product(25).



4. Impact on the right to health: using GAL in practice

The antiretroviral Stavudine, discovered and patented by researchers at Yale University, was exclusively licensed to Bristol-Myers Squibb (BMS). BMS's price was prohibitively expensive for most countries with high HIV prevalence. In 2001, public pressure from students, researchers, and MSF led Yale and BMS to allow South Africa’s leading generic manufacturer, Aspen Pharmacare, to produce generic Stavudine. The price dropped 30-fold from $1600 per patient per year to just $55, representing a 96% reduction(26). This case is one of many examples demonstrating how IP management at universities and PRIs can restrict access to university-derived health technologies(27).

When GAL is implemented, the result is strikingly different. In 2008, Dr. Kishor M Wasan developed an oral formulation of Amphotericin B, a novel agent against Leishmaniasis, at the University of British Columbia (UBC). This was the first technology where the rights to commercialization were licensed using UBC’s Global Access Principles, a policy adopted by the University Industry Liaison Office at UBC in 2007. In return for rights to develop and sell the drug for blood-borne fungal infections in the developed world, iCo Therapeutics agreed to produce and distribute the drug at-cost for treating leishmaniasis in the developing world(26).

By leveraging their ownership rights and managing their IP in a socially responsible manner, universities and PRIs can address the legal barriers to global access of health-related technologies posed by patents and data exclusivity.

5. Limitations around GAL implementation

It is clear that simply having a GAL provision on paper will not be enough to ensure access. To achieve GAL universities and PRI will need to address certain key issues which at present are often absent in the way universities and PRIs implement GAL. For instance, there has been a notable lack of transparency and information asymmetry in the licensing environment between academic institutions and industry partners can make it difficult to assess challenges and opportunities faced by universities seeking to facilitate global access of their medical technologies. Additionally, there is very limited sharing of experiences and best practices regarding socially responsible management of IP by universities and PRIs. This is, in part, due to the confidentiality and lack of transparency associated with licensing agreements and contracts.

It is important to note that GAL is just one of many measures needed to ensure global access to medicines and health technology. Alone, GAL does not solve issues such as chronic underfunding of diseases which primarily affect poor patient populations.


6. Recommendations

To promote availability of affordable health technologies, UAEM calls upon the High Level Panel to recommend governments:

- Make Global Access Licensing of health technologies at universities and PRIs mandatory for all publicly funded research. Develop and implement policies to ensure fully open and transparent technology transfer processes at universities and PRIs;
- Ensure fully open and transparent access to downstream development stages of the product;
- Actively facilitate open sharing of best practices between universities and PRIs on the socially responsible management of IP;
- Require the implementation of global health impact metrics for all health technologies produced by publicly funded research, such as those utilized by UAEM’s University Report Card(28).


7. Conclusion

The management of IP at universities and PRIs has the potential to enable or restrict access to university-derived health technologies(2). UAEM strongly advocates for the adoption and implementation of a formal GAL policy at universities and PRIs. Having seen the adoption of such policies in some of the world’s leading research universities, we seek to engage in constructive dialogue with the UN High Level Panel on Access to Medicines, regarding the potential that GAL offers, and how we can best achieve it.

"University research matters. It has the capacity to make an impact locally, nationally and globally; enriching our lives, driving our economy and contributing to greater global understanding. We also recognize that the role of a research university extends beyond innovation and encompasses a responsibility to promote a global, civil society.”(29) - University of British Columbia TTO

We welcome the opportunity to present our findings to the UN High Level Panel and to help drive this critical agenda forward so as to ensure that the fruits of publicly funded biomedical research are available for all.

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