JORDAN JARVIS, The Lancet Youth Commission on Essential Medicines Policies

Lead Author: Jordan Jarvis
Additional Author: Other members of The Lancet Youth Commission on Essential Medicines Policies
Organization: The Lancet Youth Commission on Essential Medicines Policies
Country: USA

Abstract

The Lancet Youth Commission on Essential Medicines Policies (YCEMP) was convened in March 2015 to examine access and promotion policies for Essential Medicines worldwide through a youth lens. The Youth Commission is comprised of 17 young professionals from 15 different countries, representing every region in the world.

We believe medicines should be available to all who need them, for both individuals and societies to realize their full potential, and to realize the human right to health and the right to science and culture, as recognised in the United Nations International Covenant on Economic, Social and Cultural Rights. This makes sense from both a public health perspective, and an economic perspective.

To achieve this, scientific progress and knowledge should be acknowledged as global public goods. This has significant implications for the current intellectual property and trade system, which places a disproportionate emphasis on the rights of innovators. Although those who develop drugs should benefit from their work, this cannot be at the expense of human lives. We can no longer tolerate a situation wherein the majority of the world does not have the opportunity to benefit from these developments. Indeed, the problems in the current systems restricting access to medicines, such as lack of affordability, will increasingly apply to all countries as costs of healthcare continue to rise dramatically, and new drugs are created.

In this submission, we outline specific recommendations for the High-Level Panel, and intergovernmental agencies. We recommend that:

1. An interagency task force on access to medicines be created to ensure policy coherence and improve access to medicines;
2. The task force develop indicators and monitor access to medicines in accordance with Sustainable Development Goal 3;
3. Global norms be devised to protect essential medicines within free trade agreements; and
4. Consolidation and coordination among UN agencies and disease-specific initiatives occur, to collect information around access to essential medicines.

Submission

Ensuring access to essential medicines is critical to reach Sustainable Development Goal (SDG) 3 calling for global action by Member States and stakeholders to achieve universal health care coverage, including “access to safe, effective, quality and affordable essential medicines and vaccines for all”. To ensure sustainable access to medicines, it is also necessary to focus on another target more relevant for the High-Level Panel on Access to Medicines (hereafter “HLP”): how to “promote research, development, innovation and increase access to medicines, vaccines, diagnostics and related health technologies to improve the health and wellbeing of all”.

This SDG target specifically states that this should be done in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) regarding flexibilities such as compulsory licensing and parallel importation to protect public health. Although we agree that this should occur, we would also urge the HLP not to be constrained by existing agreements and practices, and to consider novel solutions that might replace TRIPS.

RECOMMENDATION 1
Creation of an interagency task force on access to medicines to ensure policy coherence and improve access to medicines across all disease areas

YCEMP submits that concerns around innovation and access to essential medicines have been addressed to varying degrees across policy fora, typically directed towards specific disease areas such as HIV/AIDS, maternal and child health, or noncommunicable diseases (NCDs), and that this model could be replicated in achieving improved access to medicines more broadly.

For example, in 1996, the UN established the Joint United Nations Programme on HIV/AIDS (UNAIDS) to strengthen coordination across countries and intergovernmental agencies to address the HIV/AIDS crisis. Though its operations have not been without criticism, many would argue that UNAIDS has played a pivotal role in improving access to HIV treatment. In 2015, the target of providing 15 million people with treatment was reached - the first time in history that a treatment target has been reached by the deadline (UNAIDS, 2015).

In acknowledging that HIV/AIDS is a cross-cutting issue that impacts sectors outside of just health, UNAIDS took a multisectoral approach towards innovation and access to treatment. More recently, the UN Interagency Taskforce on the Prevention and Control of NCDs was formed to similarly assemble diverse actors from across the UN system to support the realization of government commitments the 2011 UN High-level Political Declaration on NCDs. How this taskforce will support the WHO goal to reach 80% availability of affordable essential medicines and technologies to treat NCDs in the public and private sector remains unclear. One of the objectives of the taskforce, however, is to address national capacity for R&D for the prevention and control of NCDs. Yet, concerted efforts must be made to link these efforts to broader discussions on R&D and access to medicines across other vertical disease programs and processes (WHO, 2014).

Discussions around health, trade, and intellectual property with regards to access to medicines illustrate that this is not only a health problem, but entrenched in other domains. It is only through ensuring policy coherence between different processes and disease areas, with an appropriate focus on access to medicines, that improvements will be made.

We envisage that the three key functions of an interagency task force on access to medicines would be as follows:
1. Coordination of interactions between health, trade and intellectual property organizations to ensure that access to medicines remains a priority in all activities;
2. Facilitation of a process to secure consensus around establishing a new and more equitable system protecting and balancing innovators’ and patients’ rights, which would ultimately replace TRIPS (and the current system of pharmaceutical patent protection); and
3. Provision of technical assistance to public research institutions to implement humanitarian licensing, as well as to educate researchers on their rights and moral obligation as innovators to ensure equitable access to innovations by the public.

Coordination between health, trade and IP organisations
An interagency task force would play a key role in ensuring that different policy processes in the fields of health, trade and intellectual property remain coherent, and do not actively undermine access to medicines, as has occurred too frequently in the past. An interagency task force would interact with other health, trade and IP organizations, such as the World Health Organization (WHO), the World Trade Organization (WTO), and the World Intellectual Property Organization (WIPO) as well as other UN agencies to maintain access to medicines as a priority goal of each of these organizations, and facilitate collaboration between these bodies to continually improve access to medicines. We do not propose to establish a new UN agency; this would be inefficient, and supplant existing agencies’ roles. Rather, an inter-agency task force would ensure coherence and collaboration between these agencies, and can assist in follow-up of the recommendations of the HLP.

This model has been used successfully in tackling other complex tasks, and we believe it could be replicated in the access to medicines space to improve coherence and facilitate agreement between stakeholders. Other settings in which this approach has been successful include:
- The interagency task force on noncommunicable diseases
- UNAIDS
- Every Woman Every Child initiative (within the office of the UN Secretary General)

Facilitation of new access to medicines consensus
It is the view of YCEMP that simply creating new mechanisms to promote the use of TRIPS flexibilities, or the enforcement of the Doha Declaration, will be insufficient to secure the system changes that are needed to make access to medicines genuinely equitable worldwide. Instead, an new system should be developed to replace the present TRIPS/pharmaceutical patents system that recognises the public importance of medicines, and better balances the rights of patients and consumers with those of innovators, for a number of reasons.

Firstly, pharmaceuticals have only recently become a key element of trade law, and indeed, have frequently been excluded from patent protection entirely in the past in certain countries. In the view of YCEMP, recent misconceptions that pharmaceutical patent protections are inevitable, and inseparable from trade law, undermine access to medicines and stymie discussions around implementation of a replacement system that could work more effectively for all stakeholders. TRIPS represented the first time that intellectual property was conceptualized as a trade issue (Dreyfuss, 2010). Until 1995, although many countries provided protection to pharmaceutical products, other countries had not, primarily on the basis that these products were too important to the welfare of their citizens (Dreyfuss, 2010). Indeed, in 1986 over fifty countries did not recognize patent protection for pharmaceuticals (So and Oh, 2011). Certain developing-country members of WTO, opposed to the inclusion of IP in trade agreements, were ultimately won over by concessions in other areas of manufacture, and bilateral trade pressure from the USA (Ottersen et al, 2014). YCEMP is of the view that TRIPS is now (incorrectly) seen as an entrenched institution from which pharmaceuticals cannot be removed, and stringent intellectual property protections for pharmaceuticals are also perceived as inarguable. This is simply untrue. TRIPS and its attendant requirements for reform of individual countries’ patent protections for pharmaceuticals do not adequately balance the needs and rights of innovators and patients, and there is no sufficiently compelling historical or public policy reason why this system in its current form need remain in place.

Secondly, TRIPS has proven to create an environment hostile to the realization of legitimate public health goals, despite repeated attempts to redress the present imbalance between innovator and patient rights. In the past, TRIPS flexibilities have infrequently been implemented by developing countries. Although these have started to be more aggressively utilized over recent years, such use is still “exceptional” (Ottersen, 2014). The Doha Declaration, too, does not appear to have provided developing countries with comfort that they would not be subject to penalties or trade sanctions for taking advantage of TRIPS flexibilities. Since 2006, use of compulsory licences has “diminished markedly”, and even where countries have strong incentives to utilize them, equally strong countervailing pressures exist not to utilize compulsory licences (Beall and Kuhn, 2012). Indeed, the Doha Declaration has been said to have “promoted only to a limited extent” the incorporation of TRIPS flexibilities into domestic law (Correa and Matthews, 2011). Repeated attempts have been made by WTO and other organizations, including WHO, to encourage countries to utilize the “Paragraph 6 System”, allowing for compulsory licences for certain pharmaceuticals to be issued in developing countries for production of medications for sale solely in countries with insufficient or no manufacturing capacity (Beall and Kuhn, 2012); this system has only been used once. In YCEMP’s view, the fact that these extraordinary, laudable efforts to improve the operation of TRIPS vis-a-vis consumers of medicines have only slightly redressed access problems, indicates that it is necessary for the present system to be entirely reexamined for change to occur at the required scale.

Thirdly, the TRIPS agreement has also been noted to have paved the way for intellectual property to become essential in trade agreements – not just those negotiated through the WTO – with the result that changes to national IP regimes are made not for health improvement, but to effectively pay for trade concessions, with the immediate effect of preventing access to medicines (Smith et. al., 2009). For countries with weak legal and economic infrastructures, the immediate benefits of increased trade “easily overshadow” the effects on increased IP protection on social welfare, which are more difficult to quantify (Dinwoodie and Dreyfuss, 145). Some have even noted that there is no clear evidence that costs incurred are compensated by “often volatile” trade advantages obtained in exchange for increases in IP protection (Smith et. al., 2009).

Finally, the inherent imbalance in TRIPS away from public health, and towards increased patent protection for pharmaceuticals, has raised the price of medicines in developing countries, putting the benefits of research out of reach for many. According to certain commentators, TRIPS “virtually assures” that diseases affecting the poor will be neglected (Dreyfuss, 2010). Moreover, as developing countries represent a small share of the world’s pharmaceutical market, the marginal added value of stronger patent protection in LMICs has been estimated to be small, and unlikely to outweigh access costs (El Said and Kapczynski, 2011). The promised direct benefits of TRIPS accession for LMICs, such as technology transfer and increased innovation, have also largely failed to materialise (Baker and Avafia, 2011).

It is for these reason that the Youth Commission believes that the current system needs to be revisited ab initio, rather than repeatedly modified in an attempt to improve access to medicines. Agreement must be reached on a new, fairer system of protections that more equally balance the rights of innovators with those of consumers of medicines, whilst minimising any chilling effect on research, development and distribution of those medicines.

An inter-agency task force could create a process bringing together all key stakeholders in the access to medicines space, with a view to securing consensus necessary to create a formal agreement (a treaty or otherwise) concerning access to medicines. It is only through a formal process involving all stakeholders – including the pharmaceutical industry – that a consensus can be reached that could translate into a corresponding unanimous vote at WTO to remove pharmaceutical patent protection from TRIPS altogether. Although we note that reaching consensus on a fair system that better balances rights would be challenging, and that it is difficult to predict what such an agreement would look like, it is the submission of the Youth Commission that this process is both necessary and overdue.

Provision of technical assistance to public research institutions
Public sector research institutions, such as universities and nonprofit research institutes, play a significant role in medical innovation. Such institutions have been estimated to have contributed to the discovery of as many as 21% of new drugs developed recently in the United States (Stevens et al, 2011). In the United States, the passage of Bayh-Dole Act (Public Law 96-517) allowed universities to file, own, and license the IP generated with government research funds. Many countries have since adopted similar practices (Cervantes, 2016). Universities have established "technology transfer offices" (TTOs) to transfer knowledge to the marketplace, by either by licensing a technology or facilitating methods for commercialization . However, there is a large diversity in the structure and organization of TTOs, both within and across countries (OECD, 2003). We are concerned that the licensing decisions made by TTOs may substantially undermine the sharing of research and other products developed in universities. This has implication on access to medicines because a lack of technical expertise, awareness of the diversity of licensing options, and asymmetrical power relations between researcher and licensing corporation may hinder the adoption and implementation of humanitarian licensing.

In its report, WHO Consultative Expert Working Group on Research and Development: Finance and Coordination (CEWG) highlighted the role of humanitarian licensing as a way to solve the issue of high prices due to monopoly by introducing licensing strategies to ensure these products become available in LMIC either through further sublicenses with generic companies, or else by requiring the private company to ensure affordable access (Chen et al. 2010). With a strong push from civil society and academia, some universities have already adopted similar policies in their TTOs. For example, the “Global Access License Principles” of University of British Columbia (Wasan et al., 2009) encourages licensee to ensure global access. The policy saw a success shortly after it was implemented, leading to an agreement for oral Amphotericin B, a novel agent against leishmaniasis developed by a university researcher, to be sold at lower price in developing countries. Similar example of licensing policies or guidelines can be found in other universities such as Emory University, University of Edinburgh, University of Oxford, University of Washington, the University College of London, and Boston University (Chen et al. 2010). There is, however, little data on universities outside the USA and Europe.

Patenting university research has been shown to facilitate the transfer of technology from university to industry, but also to delay systematically the publication of research findings and hinder the dissemination of scientific knowledge (Penin, 2010). There is also an increasing number and stacking of “upstream” patents for basic research results, accompanied with a high portion of exclusive licensing (Sterckx, 2009; Lemley, 2007) without consideration of ensuring access in the future. We are concerned that licensing decisions made by many public institutions and their researchers may not be fully informed, as a result of lack of knowledge on humanitarian licensing; moreover, at the current pace, many universities are lagging behind in terms of adopting such important practices in IP to facilitate local and global access.

The High-Level Panel has the opportunity to lead globally and to set international norms that will influence the landscape and culture of research institutions towards equitable access. We therefore call for the establishment of a working group, as part of the interagency task force on access to medicines, which could serve the following functions:
1. Provide technical support to TTOs, and share best practices, for humanitarian licensing if patented discoveries and/or other licensing approaches that prioritise access to the end product globally
2. Leading a process establishing international norms whereby the success of research teams is not merely based on numbers of patents obtained, but rather, the accessibility and effectiveness of innovations, , especially within LMICs.

RECOMMENDATION 2
Functions of the interagency task force on access to medicines to include selecting measurable indicators and working with relevant stakeholders to create an Essential Medicines Scorecard to monitor access to essential medicines

An interagency task force could have an important role in determining the indicators and data required for monitoring of access to medicines under the SDGs. While the Millennium Development Goals (MDGs) incorporated access to medicines as a necessary precondition to achieving certain targets, and then later became a target itself as part of MDG 8, the monitoring of progress around access to medicines received little political attention, especially in comparison to other targets. The SDG agenda provides a renewed opportunity to better address access to medicines by setting specific indicators for measurement on access for SDG targets 3.8 and 3.9. To ensure progress towards these targets, there must be better measurement of access indicators across countries, but also greater accountability of all relevant stakeholders - particularly at the national level. The interagency task force should collect regular reports and data from UN Member States on policies and progress, which should be made publicly available through a WHO-hosted essential medicines data repository (see Recommendation 4).

As part of this regular data collection, YCEMP recommends that an “Essential Medicines Scorecard” be developed, to monitor the implementation and impact of national essential medicines lists (NEMLs) on access to medicines locally. YCEMP envisages that the interagency task force would convene relevant stakeholders to devise the Scorecard, and assist WHO in collecting relevant data from Member States.

Essential Medicines Scorecard: an accountability tool
A national essential medicines list (NEML) should describe medicines deemed essential for the population and serve as a guide for “procurement and supply of medicines in the public sector, schemes that reimburse medicine costs, medicine donations, and local medicine production” (WHO, 2016). NEMLs can also be used as an advocacy tool to improve availability and accessibility of essential medicines (Hill et al, 2012). Research across various countries has demonstrated that, when medicines are included in NEMLs, they are more frequently available than non-essential medicines (Bazargani et al, 2014) and are often more affordable than those which are not on NEMLs (Twagirumuzika et al, 2010). One reason for this is because inclusion on NEMLs can prompt governments or other purchasing bodies to take action to obtain lower prices. For example, after implementation of a NEML in Palestine in an effort to contain costs, average medicine prices declined, along with utilization (Hamidi et al, 2008).

95% of developing countries have published NEMLs, and 86% of these have been updated in the past five years (WHO, 2010). Although a number of these countries employ an evidence-based drug selection process (Pharasi and Miot, 2013), in many countries the process and criteria for selection onto NEMLs are unclear due to a lack of transparent reporting. How NEMLs are determined, as well as who determines these, have a great impact on people’s health, so transparency is vital for accountability. Moreover, the current paucity of data on availability and accessibility of medicines restricts the monitoring and evaluation of country progress. However, increased investment in research in this area, and consolidation of national data on essential medicines in a WHO repository, would also allow for future evaluation of country progress utilizing the Availability, Accessibility, Acceptability and Quality (AAAQ) framework in accordance with a right-to-health approach.

For the above reasons, we suggest that an Essential Medicines Scorecard be developed by the proposed interagency task force, in collaboration with relevant stakeholders, as an accountability tool. The Scorecard might evaluate the following areas:
1. Monitoring the impact of NEMLs on essential medicines through:
a. Use of the NEMLs to ensure affordability, accessibility, acceptability and quality of medicines (especially in improving economic accessibility through lowering out-of-pocket medicine expenditures)
b. Removal of regulatory barriers and implementation of mechanisms for fast-tracking of essential medicines as priority goods, which may involve recognition of WHO prequalification
c. Availability of NEMLs and clinical guidelines for use in all health care facilities and by all health care providers
d. Effect of NEMLs in lowering public and out-of-pocket medicine expenditures

2. Monitoring the process by which Member States develop and maintain NEMLs
a. Occurrence of periodic, evidence-based revisions to select essential medicines for NEMLs
b. Application of clear and transparent criteria and procedures for NEML selection and revisions, including standard operating procedures, public participation, and public reporting of selection outcomes and justifications
c. A national drug policy framework supporting the EML and its implementation

A periodic review of each state’s scorecard would allow for public evaluation and comparison of countries’ progress towards realizing access to affordable essential medicines. YCEMP recommends that the proposed UN interagency task force be involved in the development of the Scorecard, but that an external body that is not governed by Member States undertake administration and implementation of the Scorecard.

RECOMMENDATION 3
Development of global norms to protect essential medicines within free trade agreements.
through trilateral cooperation between the World Health Organization, World Trade Organization, and World Intellectual Property Organization

High income countries have dominated shaping the implementation of TRIPS and its flexibilities across both countries and regions, through free trade agreements. Most notably, the U.S.has adopted a method of “forum shifting” in pursuing its IP agenda, thereby increasing the odds of successful negotiation by not limiting its efforts to an international arena (Sell 2011). Through this approach, governments voluntarily concede to expand IP protection in ways that restrict access to affordable medicines, in exchange for market access. With each FTA’s IP provisions becoming the baseline for the next agreement, the U.S. has been largely successful in pursuing an increasingly stronger IP rights agenda for medicines (Lopert & Gleeson, 2013).

Methods used for expanding IP protection in free trade agreements include provisions that enable “evergreening”, whereby minor modifications, such as new doses or delivery mechanisms, can result in new patents being granted over existing medications without any proof of increased clinical efficacy, extending monopoly protection by up to 20 years (Collier, 2013). Another IP provision commonly pursued in FTAs is requiring periods of ‘data exclusivity’ for biologic drugs, with terms lasting beyond the typical 20-year patent period. Data exclusivity prohibits drug companies from citing the patent holder's clinical trial data when seeking a marketing license from regulators (Reichman, 2009). In practice, this would mean that if a generics manufacturer wished to receive approval for a generic version of a medicine before the expiration of data exclusivity, they would need to conduct their own clinical trials - something that would be in contravention of the Helsinki Declaration (World Medical Association, 2001). These methods of seeking expanded pharmaceutical IP protections, however, are not exclusive to FTAs.

Since the early 2000s, multinational pharmaceutical companies have sought to influence high income countries’ IP agenda by serving in key advisory positions to trade ministers while other low- and middle-income countries may have more limited technical expertise in these same areas inhibiting their ability to create a counter agenda that would uphold TRIPS flexibilities (Lopert & Gleeson 2013). Additionally, public access to negotiating texts have become progressively more restricted, and agreements have provisions that bar release of the finalized text until two to four years after adoption (ref). For example, the recently signed Trans-Pacific Partnership (TPP) negotiations have been criticized for its lack of transparency. Civil society had no access to the negotiating text, while concurrently, the U.S. Trade Representative (USTR) has solicited input from industry both formally through its Trade Advisory Committee (Love et al. 2011) and informally through direct requests for input to negotiating text [REF].

It has become imperative that all stakeholders come together to develop a more balanced and inclusive approach to IP rights trade agreement negotiations, specifically in regard to access to medicines. The recently developed multilateral body of the WTO, WHO, and World Intellectual Property Organization (WIPO) Trilateral Cooperation is an ideal forum to bring together stakeholders to develop best practices in IP rights provisions coherent with already established WTO rules and resolutions passed through the WHO and WIPO (WIPO 2014).The body was formed in 2008 to pool together expertise to study pricing and procurement practices of medicines and increase inter-organizational cooperation (WIPO 2014).

Multilateral organizations have also been concerned about the impact of the FTAs in undermining their role (Blanco 2013). In July 2013, the Trilateral Cooperation published a report, with contributions from both civil society and industry, in response to an increasing demand “for strengthened capacity for informed policy-making in areas of intersection between health, trade, and IP, focusing on access to and innovation of medicines and other medical technologies” (WIPO, WHO, WTO 2013). The report also acknowledges the intensifying “need for cooperation and coherence at the international level”. Finally, middle income countries with large generics markets have been active in passing legislation to modify their patent system to protect public health. In October 2013, the South African Department of Trade and Industries launched its much-anticipated Draft National Policy on Intellectual Property, which includes recommendations to reform South African patent law to allow for the use of TRIPS flexibilities (Daniels, 2013).

Thus, the time is ripe for the Trilateral Cooperation, with its established networks of both state and non-state actors, to convene stakeholders to draft a best practices template for IP provisions in FTAs.

The creation and adoption of model language around intellectual property and pharmaceutical products will allow for a norm-setting process in which essential medicines are protected within these agreements. Such adoption will also prevent forum-shifting and ratcheting up of intellectual property rights by developed countries and industry creating a form of “soft law” for Member States to look to for guidance.

We acknowledge that the process will be lengthy and difficult, given the requirement of resolutions at each of the three multilateral organizations, as well as influence from powerful vested interests in developed countries.However, there is resounding support at the national and regional level from civil society and international organizations to put forth such recommendations. Such model language, however, will only have true effect if adopted by Member States through their legislative processes.

Accordingly, YCEMP recommends that best practice guidelines for intellectual property and pharmaceutical products within Free Trade Agreements should be created by the WHO/WTO/WIPO trilateral cooperation mechanism, and that countries should utilize these guidelines to draft model language, and adopt and implement legislation to realize the protection of essential medicines within Free Trade Agreements.

RECOMMENDATION 4
Consolidation and coordination among UN agencies to collect information around access to essential medicines

As alluded to in the second recommendation, we propose that WHO host a comprehensive and transparent essential medicines data repository. Member States should be encouraged, through incentive structures, to submit regular reports on their progress toward the access to medicines indicators set by the UN interagency task force and other stakeholders on access to medicines. The UN interagency task force should facilitate technical assistance and take steps to mobilize resources to assist Member States in collecting and evaluating data on national progress toward universal and equitable access to medicines. Additionally, the interagency task force should support WHO in consolidating relevant data from diverse UN agencies, global procurement agencies and donors and hold actor accountable to meet the SDGs.

This data should include standard operating procedures and processes for the selection of essential medicines (via National Essential Medicines Lists); steps taken and progress on making medicines on the NEML available, affordable, accessible and of high quality within the country; concrete steps taken toward Universal Health Coverage; and the submission of public data on essential medicines availability, accessibility and affordability (using evidence-based tools, such as the WHO/Health Action International Survey Methodology).

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