This invitation is not just about ‘sharing vaccines when a pandemic occurs’, it is not about ‘more global funding by the G7 or G20’ nor about ‘temporary waivers of IPR. This proposal is about global action to work towards an effective Global R&D Preparedness Ecosystem – and to improve the R&D capability of low- and middle-income countries as essential component of global preparedness and R&D Equity

A pragmatic conceptualization of a Global R&D Ecosystem opens the doors to purposeful participation by any country, no matter their stage of scientific and economic development. Any country can and should co-create, make improvements and be supported in their efforts to improve their capacity for R&D and towards scaling knowledge and products for equitable responses to any global threat. 

R&D Equity is core to achieving the SDG 2030 agenda and essential to pursuing global health, equity and development in the decades to come

 Global R&D Equity

Essential Link to Global Preparedness

INVITATION to ACT

Council on Health Research for Development (COHRED)

September 2021

Contact person for information, explanation or expression of interest:

Prof. Carel IJsselmuiden, Executive Director COHRED

1-5 route des Morillons, 1211 Geneva, Switzerland

cohred@cohred.org

 

The purpose of this call to action is to co-create a unique platform to strengthen the Research and Development (R&D) ecosystems of low- and middle-income countries as an essential component of global preparedness and efforts to realize the sustainable development goals. 

This invitation is, in first instance, directed at nations as those that implement and lead. 

Beyond nations, this invitation is to all others committed to support the growth of capable R&D ecosystems in low- and middle-income countries.

Dependence on global solidarity and generosity is not a reliable approach to global preparedness – neither for pandemics nor for global challenges resulting from climate change, growing socio-economic inequities and other major determinants of global health and well-being. A capable and flexible Global R&D Ecosystem comprising capable and re-purposable national R&D ecosystems – including in low- and middle-income countries – is a far better option for global preparedness and equitable access.

The R&D Equity initiative is uniquely positioned to achieving that.

 

Solving Vaccine Inequity requires R&D Equity

Contents 

 

Introduction

1. Lessons in Global Preparedness from the COVID-19 Pandemic 

Why is global R&D Equity necessary for the future preparedness?

Global R&D Equity confers a safer future for everyone

2. Global Pandemic Preparedness – a multitude of actions but no comprehensive global plan for equitable prevention, preparedness and control 

3. R&D Equity – the action agenda

Supporting the SDG 2030 Agenda

Creating a platform for comprehensive global action in R&D preparedness

4. Financial and Other Engagements to support the Commission’s work

5. Working with COHRED

Appendix

Key Reference Documents

Abbreviations used

 

Introduction

The ongoing COVID-19 pandemic demonstrates that the world is not yet geared to deal effectively and equitably with the prevention and control of major global challenges. The COVID-19 pandemic has highlighted the systemic inequities that pervade our societies and that are fundamental to our collective inability for rapid and effective control of the pandemic. “Vaccine inequity” and “vaccine nationalism” are both key symptoms and causes of ineffective pandemic control. They are a failure of both global justice and of global preparedness.

There is no reason to believe that the world is any better prepared to address other global challenges to health, well-being and equitable development, including challenges expected to result from climate change, threats to water and food security, and growing socio-economic inequities.

Yet, it does not have to be this way. The COVID-19 pandemic is also showing that – as a global community – we are becoming better at global collaboration, science sharing, technological innovation, and scaling production of interventions that work. These are highly positive developments on which to build the global vision and value of R&D Equity.

One of the most important but under-recognized developments in the control of the current pandemic is the active participation of middle-income countries in producing and scaling equipment, diagnostics and vaccines. Global health and development have for decades relied overwhelmingly on high-income countries’ expertise, finances and goodwill. This is now being replaced by a new paradigm in which middle-income countries are or are becoming equal partners in the global pandemic response. Thanks to the contributions by China, India, Russia and the potential contributions by many other countries such as the Philippines, South Africa, Mexico, Cuba, Thailand, Senegal and others, control can be much more rapid, effective and equitable for low- and middle-income countries accelerating global pandemic control at the same time. With the political, technical and financial support from high-income countries wishing this development to grow and succeed, meaningful technology transfer may begin to occur.

To build a world that is truly prepared – for everyone – we need to build on these major advancements. The ability of countries and regions to use and share science, use and share research and development, and do so in a spirit of partnership, solidarity and with a view to global impact is what will determine how quickly and effectively future challenges can be prevented and controlled.

A pragmatic conceptualization of a Global R&D Ecosystem opens the doors to purposeful participation by any country, no matter their stage of scientific and economic development. Any country can and should co-create, make improvements and be supported in their efforts to improve their capacity for R&D and towards scaling knowledge and products for equitable responses to any global threat.

R&D Equity is core to achieving the SDG 2030 agenda and essential to pursuing global health, equity and development in the decades to come.

1. Lessons in Global Preparedness from the COVID-19 Pandemic

The COVID-19 pandemic is far from over and the global response is at a critical phase. Stark contrasts still undermine progress, with vaccine inequity being one of the most urgent and visible issues, posing a threat to ending the pandemic and to global recovery. Over 75% of all vaccine doses have been administered in only 10 countries while the lowest income countries have administered less than half a percent of global doses – at this time.

Why is global R&D Equity necessary for future preparedness?

“A pandemic is not over until it is over everywhere”. 

A major obstacle to pandemic control is that many countries do not possess the R&D institutions, trained human work force, technical and production capabilities and financing facilities – they do not have the capable R&D ecosystems needed for local preparedness and control. As a result, global preparedness fails as well.  Neither global vaccine donations nor ‘temporary IP waivers’ are sufficient nor timely, and neither enable countries to begin solving their own problems – let alone being able to contribute to global pandemic control.

The solution to solving global problems cannot be found in a world returning to its past – in which high-income countries use their expertise, their funding, their approaches and their sense of solidarity to solve the problem for others – and, at the same time, fail to address the fundamental underlying inequities. This cannot remain the model for the future. Low- and Middle-Income Countries have to be active participants in developing their own and the global R&D ecosystems.

A defining feature of the current global preparedness is that national investments in R&D capacity have been the real driver of change. In high-income countries with the investment in basic science leading to the development of mRNA vaccines, and in middle-income countries with their ability to scale production for other low- and middle-income countries.  Without the vaccines and technical support of China, Russia, India and other middle-income countries such as Mexico and South Africa, that have actively invested in the growth and development of their own R&D ecosystems, this pandemic will continue for much longer.

Having capable R&D ecosystems to address their own health, equity and development challenges without having to depend solely on high-income country support is essential for a better, healthier, more equitable and a safer world for everyone.

Global R&D Equity confers a safer future for everyone

Countries with high-performing R&D systems and infrastructure, including local and international partnerships and networks, can use this capability also to address many other global developmental challenges. R&D system growth as a result of COVID-19 pandemic control can be repurposed to address the health, economic, and sustainable development challenges posed by other global pandemics and existential threats– including environmental pollution, climate change, economic inequities and social instability.

The R&D Equity initiative is co-created to become the multi-sectoral platform ready to tackle the challenge of improving global R&D ecosystems as essential for global health, equity and sustainable development.

2. Global Preparedness – a multitude of actions but no comprehensive global plan for equitable prevention, preparedness and control.

Given the impact on health and well-being, on mental and social health, on the global economy, and even on political relations, the COVID-19 pandemic has given rise to a massive mobilisation of national and international efforts to deal with its consequences.

Broadly speaking, there are two kinds of efforts – those focused on ending the current pandemic (COVAX, temporary IP waivers, ACT-A, vaccine diplomacy, mental health interventions) and those focused (also) on preparedness for future pandemics. (The Independent Panel, CEPI, science collaborations, World Economic Forum group). All of these call for massive resource mobilisation for a single problem – pandemic control – without much reference to all the other priority R&D needs facing low- and middle-income countries.

The responses seem similar to control efforts following large epidemics in the recent past, such as Ebola Virus Disease outbreaks in West-Africa: once the epidemic has been brought under control, substantive action stops. If we are to achieve global preparedness and more equitable action in dealing with future global challenges, then much more needs to be done in inter-pandemic periods.

The effectiveness and sustainability of a more equitable global R&D preparedness ecosystem and R&D Equity needs long-term effort, global collaboration and willingness of countries and other actors to commit major financial resources. It needs leadership which must emanate from the countries themselves, not taken over by the traditional global or bi-lateral institutions leading past efforts.

Investments in R&D ecosystem development will only happen if these investments will also contribute to social and economic progress, job creation, reduction of inequities, and mitigation of climate change impact.

R&D Equity implies R&D ecosystem development as an essential link to global preparedness for many other risks to health, well-being, and socio-economic development. The Global R&D Preparedness Ecosystem needs to be inclusive, flexible, responsive, and should create an R&D ecosystem that can be repurposed rapidly, effectively and equitably to deal with new challenges, and at the same time serve as essential components for achieving the SDG 2030 agenda.

Although there are a multitude of national and multilateral initiatives, private sector efforts and non-profit calls to action, there is no shared global vision of global preparedness. R&D Equity aims to fill the gap that exists in the contribution of science and science implementation in the global vision of global preparedness.

3. R&D Equity – the action agenda

… manufacturing capacity of mRNA and other vaccines must urgently be built in Africa, Latin America and other low- and middle-income regions. Vaccine manufacturing is highly specialized and difficult. Boosting production takes time so enabling it must begin now.

(The Independent Panel report, May 2021, p13)

Comprehensive action is required now to prepare for the future. At this time, there are many ideas, many organizations, many initiatives, many business plans but no obvious coordinator of a concerted, inclusive and global R&D Equity effort.

To achieve success in R&D Equity requires substantive support from many quarters, primarily, but certainly not exclusively, from governments, particularly in low- and middle-income countries themselves.

Effective partnerships with business, academia, science bodies, financiers and philanthropies, and non-profit organisations are essential for success. For this reason, we have to look beyond the usual inter-governmental bodies to realize the full potential of R&D Equity and achieve capable national and global R&D preparedness ecosystems.

Supporting the SDG 2030 Agenda 

Building ‘Global R&D Preparedness Ecosystems’ is a long-term, inclusive, multi-sectoral, generic and resource-intensive effort. It is not one concerted effort but will consist of many different efforts and initiatives at many different levels. Such investments are not realistic, may not be ethical and are unlikely to be sustained if they do not also serve other national and global development goals and priorities at the same time. SDG 2030 compatibility is key to success of R&D Equity and global preparedness.

To guide action towards global R&D equity,  COHRED proposes five core values:

1. Actions have to be equity focused – within countries and between countries.

2. Actions have to be deeply collaborative – between public, private and non-profit sectors, between nations, and between science and the general public.

3. Actions have to include low- and middle-income countries as active and equal players, with explicit roles and responsibilities to contribute to local and global R&D preparedness.

4. All actors have to consider and use the inter-pandemic and inter-global-challenge periods as essential preparation time for investment and support.

5. Actions cannot be constructed as another ‘vertical programme’. Effective and equitable global preparedness requires many resources and impacts on so many aspects of societies that it cannot succeed if it is designed as (yet) another ‘vertical programme’. R&D Equity has to be seen as a key input into national and global growth and development, trade, exchange, and technology transfer – in brief – as a major contributor to achieving SDG 2030 Agenda.

R&D Equity Action Agenda

Based on these values, the global R&D Equity initiative should start with a 3-year intensive preparation, planning, mapping and co-creation phase to:

• Convene the Commission on R&D Equity for Global Preparedness 

-Driven by LMICs with support from other parties interested in working towards equitable global preparedness

-Decide and agree on responsibilities and inclusive decision-making

-COHRED will act as host and incubator – leaving open the organizational options for the future

• Generate a Global R&D Equity Atlas 

-Define scope and content of R&D ecosystems and R&D Equity

-Map R&D Equity globally – develop agreed indicators

-Provide country- and region-specific data on R&D ecosystem readiness

• Link R&D Equity to other Global Preparedness efforts and SDG 2030 goals

-Engage other relevant agencies and actors – public, private, non-profit; bilateral and multilateral; regional and global

-Arrange meetings, colloquia, fora, virtual networks

-Build consensus and synergy that supports the growth of R&D ecosystems in low- and middle-income countries, promote tools needed for fair and equitable R&D partnerships

• Prepare the R&D Equity Programme of Work for a more Equitable Future 

-Present a comprehensive action plan for R&D Equity at the end of 3 years

-Agree on the organisational and financial measures, partners and collaborations to implement the Plan of Work

-Co-design, finance and implement the indicators and monitoring & evaluation, and the organizational infrastructure for regular reporting

4. Financial and Other Engagements to support the Commission’s work

COHRED will invite countries that are already firmly committed to supporting R&D Equity – nationally, regionally or globally – and are willing to invest time, expertise, diplomatic, political, financial and other resources towards achieving R&D Equity in pursuit of global preparedness.

The founding group will have a membership of 4 countries, of which at least 2 are classified as low- and middle-income countries. 

Ideally, commitments will be made in order to begin preparations for the Commission to begin its work by July 2022.

Expectations of Country Partnership and Contributions

1. Participating countries will commit to support the Commission on R&D Equity for Global Preparedness as outlined in this document, in writing, to COHRED.

2. This will include a financial commitment to enable the programme of work of the Commission during the first 3 years.

• The Commission’s work and operations require that founding countries contribute $1.5 Million for the three year period (i.e. $0.5 million per year).

• The Commission may decide to change the financial contributions for countries and other parties joining later.

• To facilitate low-income country participation, self-funding countries and non-state actors interested in supporting the Commission’s work may consider sponsoring the fees for a low-income country interested in participating in the Commission’s work.

3. As part of their contributions, countries are encouraged to provide technical and non-financial resources needed to achieve the work of the initial three-year programme of work of the Commission – in addition to their financial contribution.

This may include institutional and technical support; it could include staff, offices, meeting support, advocacy and diplomatic efforts, and any other services that may enhance the prestige and impact of the Commission’s work.

4. Be willing to start by July 2022 or as soon as possible thereafter.

5. Countries interested in joining the COHRED Board of Directors are welcome to send such expression of interest to the Executive Director. COHRED is open to discuss any suggestions that can strengthen the Commission on R&D Equity for Global Preparedness.

5. Working with COHRED

The Council on Health Research for Development (COHRED) was established in 1993 as an independent, international non-governmental organisation to support low- and middle-income countries to implement the ‘Essential National Health Research’ (ENHR) strategy. Over the years, COHRED has partnered with many countries that were and are committed to use science for health, equity and development – from the smallest countries, including Cuba, Benin, Vanuatu and Laos PDR, to the largest ones, including Nigeria, Brazil, The Philippines, Thailand and China.

COHRED has progressively widened its focus from the original ENHR strategy. At first, from the Second International Conference on Health Research for Development in Bangkok in 2000, this effort concentrated on supporting the definition and strengthening of ‘national health research systems’ (NHRS).

In subsequent years, COHRED’s initiated the message that ‘health research’ is too limited a concept to really achieve health and that ‘research for health’ should be the new way forward. By 2008, the WHO, COHRED and the Global Forum on Health Research had teamed up with Mali to deliver this message loud and clear during the Bamako Forum on Research for Health in 2008. Since then, COHRED has been engaging with research systems in many low- and middle-income countries, on request, to work on national research system development that could address health, equity and socio-economic development.

Most recently, COHRED developed the prime global tool to create transparency in and learning for fairness in global research partnerships involving low- and middle-income countries – the Research Fairness Initiative (RFI). The RFI is also intended as a very pragmatic instrument to operationalize SDG 17 (“Partnership for the SDGs”).

COHRED is not a funder; rather it receives funding from bilateral and multi-lateral agencies, philanthropies, regional organizations, and from selected businesses for specific projects. User fees for some of its services has supported its revenue generation. COHRED remains independent of sectoral, political or other interests.  COHRED’s approach has always been one of ‘inclusiveness’ of all partners, consultation, co-design and co-creation, and – as a result – COHRED is seen by many in low- and middle-income countries as a trusted partner.

Structurally, COHRED is an Association under Swiss Law in the Canton of Geneva and is recognized as a ‘non-State Actor in official relations with the WHO’. It also holds observer status with WIPO, the World Intellectual Property Organization. It has an affiliate organization based in the State of Delaware in the USA (COHRED USA). The Global Forum for Health Research merged into COHRED in 2011 – providing substantive institutional capabilities and memory of hosting global meetings, large and small.

The Board and Management of COHRED believe that with its unique focus on research system capacity support for low- and middle-income countries since 1993, its engagement with many governments – research organizations and businesses – non-profit organizations – bilateral and philanthropic funders over more than 25 years, as well as its continued international and independent organizational and financing model, COHRED offers the best organizational basis to host and incubate the R&D Equity initiative and platform. This enables all future organizational options to remain open, including creating an organizational framework outside COHRED.

 

Council on Health Research for Development (COHRED)

1-5 route des Morillons 1211, Geneva 2, Switzerland

www.cohred.org

 

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Appendix

Key Reference Documents

A New Commitment for Vaccine Equity and Defeating the Pandemic. (“Investing US$ 50 billion to end the pandemic is potentially the best use of public money we will see in our lifetimes”). Kristalina Georgieva (IMF), Tedros Adhanom Ghebreyesus (WHO), David Malpass (World Bank Group), Ngozi Okonjo-Iweala (WTO). World Health Organization, Newsroom. 31 May 2021.

Advancing Epidemics R&D to keep up with a changing world: progress, challenges and opportunities. Wellcome Trust. 12 August 2019.

African countries must muscle up their support and fill massive R&D gap. Janet Midega, Catherine Kyobutungi, Emelda Okiro, Fredros Okumu, Ifeyinwa Aniebo, Ngozi Erondu. The Conversation. 18 May 2021. 

Audit of the World Health Organization (WHO) for the Financial Year ended 31 December 2020. Office of the Comptroller and Auditor General of India. 17 May 2021. 

China’s International Development Cooperation in the New Era. The State Council Information Office of the People’s Republic of China. January 2021.

COVID-19: Collaboration is the engine of global science – especially for developing countries. Kituyi M. World Economic Forum. https://www.weforum.org/agenda/2020/05/global-science-collaboration-open-source-covid-19/. 15 May 2020/

COVID-19: make it the last pandemic. The Independent Panel for Pandemic Preparedness and Response. May 2021.

COVID-19 preparedness: capacity to manufacture vaccines, therapeutics and diagnostics in sub-Saharan Africa. Bisi B, Chinedum PB, Sam-Agudu NA, et al. BMC Globalization and Health. 2021.

Covid-19 Research And Innovation Achievements. WHO. R&D Blueprint. April 2021.

Definitions of Research and Development: An Annotated Compilation of Official Sources. National Science Foundation (USA). March 2018

DOST, DOH to probe vaccine mixed-dose approach. Philippine Council for Health Research and Development. https://www.pchrd.dost.gov.ph/news/6678-dost-doh-to-probe-vaccine-mixed-dose-approach. 31 May 2021.

Fair Research Contracting (FRC). https://frcweb.cohred.org

France and development research. https://www.diplomatie.gouv.fr/en/french-foreign-policy/scientific-diplomacy/france-and-development-research/. Accessed June 2021

France to help Africa boost Covid-19 vaccine production, Macron says. France 24. 28 May 2021. https://f24.my/7hn7

G7 must bear the burden of vaccinating the world. Time is short if the battle against Covid-19 is to be won and the economic gains realised. Gordon Brown. Opinion Covid-19 vaccines. Financial Times 22 May 2021.

Health Research. Essential link to equity in development. Commission on Health Research for Development. Oxford University Press, 1990. http://www.cohred.org/publications/open-archive/1990-commission-report/

New Partnership To Boost Africa’s Vaccine Research, Development And Manufacturing. Health Policy Watch. 15 April 2021.

Outbreak Readiness and Business Impact. Protecting Lives and Livelihoods across the Global Economy. World Economic Forum. 2019.

Overcoming gaps to advance global health equity: a symposium on new directions for research. Frenk J, Chen L. Health Research Policy and Systems. 2011.

Post-pandemic transformations: How and why COVID-19 requires us to rethink development. Leach M, MacGregor H, Scoones I, Wilkinson A. World Development. 16 October 2020.

Priorities for COVID-19 research response and preparedness in low-resource settings. GLOPiD-R Secretariat. Lancet 22 May 2021.

Prioritizing Financing Systems for Pandemic Preparedness? Carel IJsselmuiden, Francine Ntoumi, James V Lavery, Jaime Montoya, Salim Abdool Karim, Kirsty Kaiser. Lancet 2021, July 31; 398: 388.

Research Fairness Initiative (RFI). https://rfi.cohred.org

Restoring Vaccine Diplomacy. Hotez PJ, Narayan KMV. J American Medical Assocation (published online). 28 May 2021

South Africa and the Global South’s battle for Covid-19 vaccine justice. ‘The loss of humanity’. Karrim A. https://www.news24.com/news24/opinions/fridaybriefing/the-big-picture-the-loss-of-humanity-south-africa-and-the-global-souths-battle-for-covid-19-vaccine-justice-20210304 News24. 4 March 2021.

Swiss Health Foreign Policy 2019-2024. Swiss Federal Council. 15 May 2019.

The Collapse of Global Cooperation under the WHO International Health Regulations at the Outset of COVID-19: Sculpting the Future of Global Health Governance. Taylor AL, Habibi R. ASIL Insights. The American Society of International Law. 5 June 2020.

The COVID vaccine pioneer behind southeast Asia’s first mRNA shot. Nature. 26 May 2021.

The Neglected Dimension of Global Security: A Framework to Counter Infectious Disease Crises. Commission on a Global Health Risk Framework for the Future. National Academy of Sciences (USA). 2016.

The R&D Preparedness Ecosystem: Preparedness for Health Emergencies Report to the Global Preparedness Monitoring Board. Keusch GT, Lurie N. US National Academy of Medicine. 9 August 2020.

UN chief calls for a global partnership to address COVID, climate change and achieve SDG’s. UN News. 30 May 2021. https://news.un.org/en/story/2021/05/1093052)

Urgent lessons from COVID 19: why the world needs a standing, coordinated system and sustainable financing for global research and development. Lurie N, Keusch GT, Dzau VJ. Lancet. 9 March 2021.

Wanted: trusted rules for emergency data access. Editorial. Nature 3 June 2021; Vol 594, 8.

 

Abbreviations & terms

ACT-A                   Access to COVID-19 Tools Accelerator

CEPI                     Coalition for Epidemic Preparedness Innovations

COHRED             Council on Health Research for Development

COVAX Facility    COVID-19 Vaccines Global Access Facility

COVID-19            Corona Virus Disease

FRC                      Fair Research Contracting

GLOPID-R           Global Research Collaboration for Infectious Disease Preparedness

IMF                       International Monetary Fund

IPR                       Intellectual Property Right(s)

R&D                      Research & Development, Research and Development

RFI                        Research Fairness Initiative

SDG 2030            Sustainable Development Goals (2030 Agenda)

WHA                     World Health Assembly

WHO                    World Health Organization

WIPO                    World Intellectual Property Organization

WTO                     World Trade Organization

 

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By COHRED recently on PEAH

Fair Research Contracting – Key to Promoting Solidarity for Science and Development in a post-COVID-19 World by Carel IJsselmuiden, Kirsty Kaiser, Abigail Wilkinson, Farirai Mutenherwa 

Fair Research Partnerships in European Commission Funded Research by Carel IJsselmuiden and Kirsty Klipp

 

...from health policy priorities perspective, the more systemic danger of TTIP is that it could hinder necessary change of corporate profiteering and an already failing model for innovation and R&D towards pharmaceutical policy in the public interest...

by Meri Koivusalo*

Senior Researcher on Health Policy
National Institute for Health and Welfare
Helsinki

No Ordinary Free Trade Agreements  – Health and the New Generation Trade Agreements

 

The new generation trade agreements, such as the TPP (Trans-Pacific Partnership) and TTIP (Transatlantic Trade and Investment Partnership), have changed the ground and context of trade negotiations through extension of negotiations further to national policies and regulation. These new generation trade agreements have gained criticism not only from activists, but also from international and US economists (Krugman 2015, Summers 2015, Stiglitz 2015).

What has been made clear is that these are no ordinary free trade agreements. In Europe and in particular in European Union focus remains, perhaps unsurprisingly, dominated by trade and export opportunities. This is reflected, for example, in the number of references to EU- South Korea FTA as an example of prospective benefits from a trade agreement (Malmström 2015a):

“We know that trade agreements do bring benefits. Since the EU-South Korea free trade agreement entered into force in 2011 our exports are up by 35%. In some sectors, like cars, they are up by 90%.”

On the other hand TTIP remains promoted explicitly due to the assumed benefits for global standard-setting at a higher-level. The European Union trade policy materials make the point that:

“Aligning EU and US standards and regulations would mean exporters in other countries would only have to comply with one set of rules instead of two.  This would make it easier for them to export and would help their economies.

Aligning EU and US standards and regulations could also provide the basis for high global standards, bringing benefits to consumers and business alike.” (European Commission 2015)

The current engagement with negotiations thus implies a road paved with opportunities and win-win options, yet it seems that many of the claims would require further elaboration.  Furthermore, they do not seem to really hold, when what is actually negotiated is put under scrutiny. In other words, while there may be many lofty aspirations of what is to be achieved, what is negotiated is what counts.

The problem of comparing EU- South Korea FTA with potential benefits from TTIP is of course that it does not compare like with like as trade negotiations with US exceed in breadth what has been agreed with EU-South Korea agreement.  Change is also dependent on situation before and after as well as how particular markets are shaped.  It is also clear that realization of some aspects of what was negotiated with EU- South Korea agreement, for example, in the pharmaceutical annex, will be more problematic in the context of negotiations of TTIP. The likelihood of EU-Korea and the US-Korea agreements to be used as basis for further negotiations has already drawn attention from the European Consumer Organisation (BEUC 2015).

While the rationality of achieving common regulatory practices for the benefits of trade are emphasized, it is not made clear how the scope and requirements for regulation are affected and how a stronger role of multinational industries can affect policy space for health both at European and national and local level role in domestic regulation.  Promises of not lowering current standards are not sufficient, when what matters is how and on what basis new standards can be set and new regulation can take place. Furthermore, through constraining the process of standard-setting and establishing new requirements for regulatory process, the negotiations do have implications for regulatory policy space, even if it would not directly restrict or explicitly deny a possibility for higher level of standards. The purpose and role of regulatory council envisaged as part of negotiations may also have different implications to the Parties. There already exists a relatively strong centrally based presence of regulatory affairs in United States (Office of Information and Regulatory Affairs, OIRA) making this more easily negotiable for USA.  The idea of oversight on regulatory initiative across Atlantic may be appealing to many industries, but may look different from the perspective of Member States.

In many areas industries are no longer local and interests promoted at EU level will be similar to those in USA.  Yet, it is clear that common regulatory process and requirement standards set under influence of multinational actors can be against public interest and the interests of citizens of European Union Member States and citizens of United States, while still making it easier and more beneficial for multinational industries to trade across countries. The win-win for global corporate interests can become a “lose-lose” for public health and public interest.

TTIP and global governance

We do need to question why we should negotiate all public policy and regulatory issues under trade agreements, where agenda is more easily dominated by interests of multinational corporations and coalitions of export industries, when there are other forums for international cooperation. Trade policy should not be the only show in town.

We have United Nations specialized agencies involved with health and food safety. It is perfectly possible to seek closer transatlantic cooperation through other means than trade agreements. If improving regulatory frameworks is the aim of the game, then why are we seeking this through the most difficult route, where corporate interests, in particular, dominate? Another explanation is that what is understood as improvement actually considers improvements for corporate beneficiaries or trade.

This would not need to be the case. Furthermore, the principles and objectives of the Unions’ external action have been defined in TEU (Treaty on European Union) 21 (1) as follows:

1. The Union’s action on the international scene shall be guided by the principles which have inspired its own creation, development and enlargement, and which it seeks to advance in the wider world: democracy, the rule of law, the universality and indivisibility of human rights and fundamental freedoms, respect for human dignity, the principles of equality and solidarity, and respect for the principles of the United Nations Charter

The Union shall seek to develop relations and build partnerships with third countries, and international, regional or global organisations which share the principles referred to in the first subparagraph. It shall promote multilateral solutions to common problems, in particular in the framework of the United Nations and international law.

These should, in principle, guide also the European Union commercial policy. According to the TFEU (Treaty on the Functioning of the European Union) Article 207 (1) commercial policy is to be “conducted in the context of the principles and objectives of the Union’s external action”. This is partially reflected in Commissioner Malmströms’ speech, where she has emphasised values in foreign policy context of commercial policies (Malmström 2015b):

“When partners sign EU trade agreements, they commit to the core standards of the International Labour Organisation– like the right to form unions and strike. They also agree to environmental treaties on issues like transport of hazardous waste and the protection of endangered species.”

…//…

“Furthermore, we also use strategic bilateral trade agreements like the Transatlantic Trade and Investment Partnership as a vehicle to support those EU values that we share with the US – like democracy, open markets, the rule of law, and respect for the individual.”

The challenge is that if TTIP negotiations really represent the democratic values we wish to uphold, it is clear there is a problem in terms of how these democratic values are currently understood, delivered and respected as part of the negotiation process.  United States has not ratified more than two of the eight ILO standards (ILO 2015).  According to ITUC (International Trade Union Confederation) report South Korea is known to have ratified only four of the ILO core labour standards, which do not include right to form Unions and strike (ITUC 2012).  The list of common values promoted by the TTIP seem to lack human rights, equity and solidarity – or perhaps it has been implicitly recognised, that TTIP is not a vehicle to support human rights, equity and solidarity.

If we focus on global governance and the role of European Union, it is possible to argue that current commercial policies are not fully in line with principles and objectives of the European Union external policies. The aim to feed rest of the world standards and regulatory cooperation practices agreed between European Union and United States does not fit well with external policy priorities on multilateral cooperation. It is also unclear how negotiations of TTIP and in particular on investment protection and trade secrets relate to promotion of democracy or consideration of TTIP as a vehicle for promotion of democracy globally.

The relationship between global industries and public policies

The estimates of economic benefits from TTIP have been under scrutiny, but what everybody seems to agree is that key implications from TTIP do not result from lowering tariffs, but from “beyond the border measures” , through changes in future requirements for regulatory measures.  These are much harder to estimate and can also imply unanticipated costs. The question on regulatory action is not just about trade barriers. For example, Joseph Stiglitz has emphasised that (2015):

“Rules and regulations determine the kind of economy and society in which people live. They affect relative bargaining power, with important implications for inequality, a growing problem around the world. The question is whether we should allow rich corporations to use provisions hidden in so-called trade agreements to dictate how we will live in the twenty-first century. I hope citizens in the US, Europe, and the Pacific answer with a resounding no.”

What is negotiated in TTIP does relate to health and social policies as what is proposed will have implications to health promotion, protection as well as to financing and organization of health services and social security. While European Union has made promises to exclude publicly funded health services, these remain constrained by overarching commitments to investment protection and potential for overarching obligations for national treatment of investment, regulatory cooperation and in relation to state enterprises and government interventions can. At the core of the concerns is the lack of clear-cut and unequivocal exclusion of health services and social security from the negotiations with potential expansion of more general obligations. (see below)

Regulatory cooperation under TTIP can perhaps be best described as a process seeking to establish procedural framework on how governments can regulate. As these procedures make regulation more burdensome and allow stronger engagement of stakeholders and the other negotiation Party, it is likely to hamper the scope of regulatory measures that governments can take.

Lack of regulation has human and societal costs. What provides benefits for investors and corporations, does not automatically lead to benefits for all, but can imply substantial costs for society at large. The 119 billion € estimated economic benefits of TTIP after ten years on the basis of the Centre for Economic Policy Research (CEPR 2013) assessment are comparable to, although lower than,  estimated annual social costs of alcohol, which have been estimated as 156 billion € (Rehm and Shield 2012). Endocrine disruptive chemicals have been estimated to result in attributable costs of similar annual magnitude to the expected benefits of the TTIP in European Union (Trasande et al. 2015).  The costs of lack of regulation and regulatory action can thus be substantial both in terms of monetary and human costs. The additional requirements and bureaucracy also imply costs for public authorities if they wish to uphold capacity for regulatory action.

While negotiators keep on emphasizing that existing regulatory levels will be upheld, the more cumbersome and more requiring future regulation is made, the harder it will be to enact new regulatory measures.  It is also not clear how TTIP relates to revision of existing regulations and standards. This is particularly important to consider if European Unions’ REFIT (Regulatory Fitness) measures, which will open up and reassess regulatory measures in future as then revision of these new regulations, could be affected by new requirements set as part of TTIP negotiations.

As we are told the importance of growth and the TTIP a crucial means for new growth, it is also necessary to ensure that what is negotiated does not result in “cold growth” accumulating in tax havens with increasing social inequalities, declining public funds, strengthening of the position of multinational industries and corporate monopolies, worsening terms of employment, increasing vulnerability to financial crises, more complex public bureaucratic requirements, and regulatory and public policy impotence.

Enhancing innovation and pharmaceutical policy in the public interest?

A particular case of point needs to be made with respect to pharmaceuticals. It is necessary to ask what public benefits will an even greater influence of global pharmaceutical industry bring to the market approval and reimbursement process of new pharmaceuticals?  It has already been shown that corporate influence can play an influential role in reimbursement decisions in Europe (van Herk et al. 2013).

While the formal focus on pharmaceuticals and TTIP has been on policies with respect to generics and imports from third countries, the real cost pressures for national health systems come from new medicines. High prices of new medicines in both United States and European Union have led to legitimate concerns over the longer term sustainability, affordability and added clinical value of the new medicines, priced at the level that markets can bear.  Yet the TTIP negotiation seem to focus on making it harder for the public administrations to intervene or influence pricing of medicines, while empowering the pharmaceutical industry to maintain and strengthen the current regulatory context and position of major multinational players. Furthermore, from health policy priorities perspective, the more systemic danger of TTIP is that it could hinder necessary change of corporate profiteering and an already failing model for innovation and R&D towards pharmaceutical policy in the public interest.

It is reasonable to assume, that what has been negotiated under Trans-Pacific Partnership (TPP) will emerge to the agenda of the TTIP negotiations. We can thus form some understanding of issues at table from what has been negotiated on the basis of the leaked pharmaceuticals annex of the TPP (TPP 2015). While United States representatives have denied that the transparency annex could be subject to investment protection claims (Weisman 2015), this would be surprising as procedural fairness, which is the aim of the very chapter, provides a feasible route for claims. The relationship between requirements for procedural fairness and what is considered as fair and equitable treatment may also be closer than assumed. Indeed, European Commission explanatory note on investment protection uses these interchangeably:   “Protection against unfair and inequitable treatment – e.g. denying basic procedural fairness “(European Commission 2013, p. 4).

While it may be understandable that producers might seek to ensure the best treatment for their products in other countries, it is not sufficiently recognised that TTIP negotiations can have substantial implications to the ways in which medicines are approved to markets and reimbursed, in particular, within European Union.  Furthermore, while “transparency” seems to be sought in the reimbursement process, there are due concerns over implications of transparency directive to progress in access to data on clinical trials in Europe , which has been criticised by American research-based pharmaceutical industry in their 2014 submission to USTR 301 trade review (PhRMA/USTR 2014). Public health groups and researchers have already drawn concern over definition of trade secrets as part of the transparency directive and links to TTIP negotiations (HAI ym. 2015). Transparency should also not imply a shift towards legitimizing direct-to-consumer advertising in Europe as the TPP transparency chapter seems to seek legitimising more broad-based direct-to-consumer advertising through the internet (TPP 2015).

The danger of the TTIP is that it becomes a protective shield for corporate benefits against duly and timely efforts to change public policies in limiting markets, when commercialization of services becomes too costly, when public interests and opinion do not support profiteering in health services or favour non-profit organizations or public provision (e.g. in publicly funded services), or in the case of pharmaceuticals, using competition to lower prices.  Furthermore, while TTIP is likely to bring growth to the multinational pharmaceutical industry, it is less certain that this will result in taxable income, innovation or cost-effective clinical benefits to patients. On the other hand we can be relatively confident that if exclusivities for pharmaceuticals are expanded or lengthened as result of the negotiations, this is likely to take place at the cost of public purse and those ill, not only within Europe and United States, but as well globally.

We need to be clear that when “high standards” are discussed  this does not only apply to investment and intellectual property rights as it is also important to recognise that trade negotiations can lead to transatlantic sinking of new safety standards, while protecting and tightening those which serve particular interests.  What is good for European Union exporters and industry may not necessarily be safe or great for consumers.

Are health services as “safe” as is claimed ?

TTIP is a negotiated treaty and has its focus on where political priorities are set. It is clear, that while there have been statements on public services (European Commission 2015), this has not so far resulted in explicit exclusions of these services from negotiations.  Legitimate concerns over health, education and social services seem to have become dealt with by separate statements and promises, which are likely to be forgotten, when the final agreement has been signed. We know that it is entirely possible to establish clauses and articles excluding services and sectors or declining to negotiate on investment protection. It is thus a matter of political choice whither we accept health and social security exclusions to remain aspirational and vulnerable to interpretation or explicit “hard” priorities representing European values on what is to be traded and what is not.  It is also likely that other chapters under negotiation, such as government procurement, competition, subsidies or state owned enterprises will have relevance to how publicly financed services can operate and whither these can compete against commercial providers.

There is a danger that trade negotiators may implicitly consider government and public services role as a residual function, where there are no commercial interests. Trade agreements may also impede European problems as internal market rules and regulations may be considered as a starting point for negotiations with third countries.  This applies not only to health services, but as well how services of general economic interest and general interest are understood. The problems emerge if public funding and role for health care provision is pushed to a residual function and required not to affect markets, then excluding publicly funded health services just means excluding services for which there are no commercial interests or which are not tradable.

One concern in relation to the TTIP is the emphasis on general rules and priorities across all sectors. This is reflected in the regulatory chapter on general principles which seeks to build on previous OECD guidance (EU/TTIP 2015).  The shift towards a more general application of rules applies also to TISA (Trade in Services Agreement) negotiations on services on which the TTIP builds, where a push seems again to be from specific commitments to more horizontal obligations (TISA 2015). European Union and Singapore FTA investment chapter expands national treatment obligations for investment to all sectors, including health, social and educational services, with the exception of audiovisual services and procurement for governmental purposes (EU-SSFTA 2014). It may thus be expected that European Commission will seek to expand this horizontal inclusion of national treatment of existing investors in all services also to TTIP. This is not about trade, it is about regulation of national policies.

This has relevance with respect to the role and position of non-profit providers and can affect how services of general interest and general economic interest are treated in service provision as a government may wish to treat these differently from commercially driven multinational corporations, which can provide “like services”. The application of restrictions to performance requirements could limit means to ensure continuity of care, equity in access to services or to ensure efficient use of resources within the health system.

Health services or national exclusions on health services from trade agreements are not necessarily as “safe” as we have been told, if exclusions only apply to ability to restrict new establishments, while governance of national policies and investment has slipped further under trade agreements.

The paradox of evidence in the context of TTIP negotiations

The paradox of the TTIP negotiations is that an international legal framework limiting public policy options and policy space for health is negotiated with very limited evidence on broader societal benefits, while this very framework will not only require increasing and more narrowly defined evidence for future regulatory measures to take place, but can also make it more difficult to gain evidence for public policies and regulation for health.

It is clear that costs from TTIP have not been addressed fully in terms of investment protection, lack of regulatory action, regulatory burden for governments or increased costs for new medicines and technologies. Even broader financial sustainability issues may be at stake in the context of financial services chapter, including social security systems or vulnerability to new financial crises. The legal language introduces new terminology and obligations, which may not be fully understood in terms of implications as this type of requirements may not have been dealt with as part of health policy-making and governance.  While consultations have provided managed information and sharing of European Union stances to the wider public and academic research, which is an improvement, the consolidated negotiation texts are still available only to chosen few.

The focus on transparency may seem a move to the right direction, but measures promoted under transparency seem to go only to one direction. There is a danger of creating a transparency ratchet, where all that is on public sector remains open and accessible to early scrutiny by corporations, while at the same time access to information for regulatory purposes from the corporate sector becomes safeguarded by stronger protection of trade secrets.

A major challenge with respect to “evidence” relates to precautionary principle. It is also clear that impact assessments have shifted to serve more commercial needs with proposals of regulatory and trade impact assessments (EU/TTIP 2015). A reaffirmed commitment to OECD good regulatory practices is to be made as part of the agreement (OECD 2012), which raises also questions of purpose and role of the regulatory cooperation focus. If OECD already provides soft guidance on regulatory cooperation, the TTIP can’t be about “soft” guidance, but seems to be much more about locking in a framework for regulatory cooperation and enforcement through TTIP.  Furthermore, if the agreement is a “living agreement”, the initial negotiation round will need to be only a placement for further negotiations.

If TTIP is the answer, then what is the problem?

It is possible to argue that trade should preferably be negotiated under multilateral governance with a broad participation and actual transparency, rather than making a bilateral deals and then imposing them to all others, which does not sound as great foreign policy or respect for democratic accountability.

Governments can deregulate without a broader international framework and if TTIP partnership is only about “encouraging” regulatory cooperation, then perhaps this encouraging could be done in a less legally binding form under OECD. Most of health promotion legislation has not taken place as result of international agreements, but as result of governments following wise regulatory measures of other governments.  As world has not ended in spite of corporate predictions, other governments have dared to follow the lead. However, the TTIP fits perhaps too well with an aim to ensure that there is less scope for innovative regulatory measures for the benefit of public health policies through the imposition of a more restrictive overarching regulatory framework, enhancing investor and intellectual property rights protection, and enabling early corporate presence as part of the regulatory process.

Do trade policies then really suffer from lack of empowerment of multinational industries and insufficient consideration of corporate and transnational investor interests as part of public policy-making and regulatory decisions in European Union and United States?  Do we really need to have consultations across Atlantic or a regulatory council on potential regulatory interests in case these might affect trade interests? Why should framework for health-related standard-setting and regulation be decided under closed trade negotiations between United States and European Union?

The pass of the fast track vote in USA implies that more scrutiny and oversight is now required from the European Union side and, in particular, from the European Parliament. The process of the European Parliament vote was not promising. If a closer partnership is to be desired, then any advancement of regulatory cooperation with respect to pharmaceuticals, health promotion, health, environmental protection and safety should best take place elsewhere, than under trade or corporate friendly regulatory councils governed under trade and economic policy priorities. Innovative solutions could be sought on the basis of public health and health policy priorities and has been done. The point is not about international cooperation, it is about where, on what basis and for what purpose this cooperation takes place.

 

References

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*Meri Koivusalo is a senior researcher in National Institute for Health and Welfare in Finland. She is a medical doctor with a PhD in public health and MSc in environmental health policy. She has written and published on international and European health policies, including on trade and health. She has followed trade policy developments for more than 15 years. She has served as an advisor for Finnish Ministry of Social Affairs and Health as well as for European Commission DGV, DG VIII and WHO. She was a member of the WHO Consultative expert group on research and development: financing and coordination (CEWG).