Concept Note

2nd World Conference on Access to Medical Products-Achieving the SDGs 2030 9-11 October 2018, New Delhi, India

I. Introduction

WHO embarked on 13th Global Program of Work1 (GPW13) for strategic direction in Sustainable Development Agenda 2030 (SDG) for health which is vital for the future of our world. The GPW13 states people continue to be susceptible to communicable diseases while the burden of non-communicable diseases is increasing. The WHO Constitution affirms the health of all people is fundamental to the attainment of peace and security and is dependent on the fullest cooperation of individual and States. GPW 13 is structured around the “triple billion” goal for three interconnected strategic priorities: Healthy Lives – 1 billion more people living healthier lives Universal health coverage – 1 billion more people with universal health coverage Health emergencies – 1 billion more people made safer (making us all safer)

It is clear that reliable access to effective, safe, quality-assured and affordable medical products (medicines, vaccines, diagnostics, devices) is key to making progress towards Universal Health Coverage and the SDGs. Universal health coverage includes appropriate access to affordable and quality-assured medical products supporting countries in achieving the targets of the health SDGs.

The contribution of India for access to medical products worldwide is well recognized. India is a major manufacturer of medical products and generics. In vaccine manufacturing regulation a team of international experts convened by WHO in 2017 assessed India’s NRA to see if it meets WHO standards and found the National Regulatory Authority (NRA) is well equipped to produce and monitor safe, effective and quality vaccines. This facilitates WHO prequalification of Indian manufacturers, which will allow them to supply vaccines through the international procurement system, a major breakthrough for vaccine supplies to low- and middle-income countries. India recognizes that scientific progress is key and R&D for development of affordable products with supportive technology platforms, network of clinical sites and testing facilities and health technology innovation is critical for meeting health needs.

In several recent WHA resolutions it has been recognized that health systems need to promote access to essential medical products (medicines, vaccines, diagnostics, devices) to ensure universal access to health care, rational use of medicines and the sustainability of health systems2. Further, in 2016, the report of the UN Secretary-General’s High-Level Panel on Access to Health Technologies targeted incoherencies between trade and public health objectives. At this year’s World Health Assembly (WHA2018), the WHO Secretariat was tasked with developing a roadmap on access to medicines and medical products3, in time for the next Executive Board. Investment in research for new products, especially for health conditions prevalent in low- and middle-income countries, is essential. At the same time, public health needs must be protected. In practice, greater capacity to work within intellectual property and competition rules, and use TRIPs flexibilities4 would help improve access for Medical products.

WHO policies promote appropriate access to medical products, in line with the WHO’s global strategy and plan of action on public health, innovation and intellectual property, including policies on: access to generic medicines and innovation; quality-assurance of products through effective regulation; affordable pricing; streamlined procurement and supply chains; and promoting rational use of medical products. WHO is working to promote policy and technical dialogue on antimicrobial resistance across sectors to provide strategic support based on the Global Action Plan on Antimicrobial Resistance, the 2030 Agenda for Sustainable Development and the Political Declaration of the high-level meeting of the General Assembly on antimicrobial resistance.

Access to essential medicines has been a priority in the Regional Flagship on UHC since 2014. To improve the quality and safety of medical products India is actively participating to promote regulatory collaboration for access to medical products through the South-East Asia Regulatory Network (SEARN). SEA Region Member States Regional Committee has endorsed ten medicines-related resolutions since 2002, of which four are current5.

The 1st World Conference on Access to Medical Products and International Laws for Trade and Health, in the Context of the 2030 Agenda for Sustainable Development held in New Delhi, 2017 focused substantially on ways to address these challenges6. The 1st World Conference 2017 led to 142 recommendations related to national and international policies for Access to medical products agenda (in the framework of globalization and trade agreements). The contribution of partners to the Conference: WHO, Biotechnology Industry Research Assistance Council (BIRAC), a public sector undertaking of the Department of Biotechnology, Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology, Government of India, ICMR, Indian Society for International Law was invaluable. Key ministry(ies) have been identified for implementation of the Recommendations and nodal officers are designated to jointly coordinate for the purpose. Given the importance of the agenda, the Ministry of Health announced the “2nd World Conference on Access to Medical Products – Achieving the SDGs 2030” during the 2017 Conference itself. The 2nd World Conference 2018 seeks to build on the consensus and deliberations made in the previous Conference. The Agenda of the 2nd World Conference 2018 reflects these priorities.

II. Objective

The main objective of the 2nd World Conference 2018 is to take forward the recommendations from the 1st World Conference 2017 and build on the work done for access to medical products in the context of SDGs (including trade agreements) in line with GPW 13 of WHO.

Specific objectives

The specific objectives are to:

1. Take forward recommendations of the 1st World Conference 2017 at national and international levels

2. Promote enabling ecosystem in the context of 13th GPW for access to medical products

3. Foster new approaches in innovation landscape for medical products and health technologies for accelerating research and innovation

4. Identify knowledge, information and policy options on the interface of international trade and health to achieve SDG 2030 goals.

III. Discussion Themes

The 2nd World Conference 2018 will take forward the international and national discussions for access to medical products.

A. GPW 13, Innovation, Manufacturing

Sub themes

  1. 13th GPW for Access to Medical Products to achieve SDG 2030 Goals
  2. Update on progress from 1st World Conference 2017
  3. Innovation Policies for Medical Products
  4. High-end Manufacturing of medical products
  5. Tracking of investment into product R&D

B. Regulation and Access

Sub themes

  1. UN General Assembly Special session -Health Technology Innovation and Access
  2. Diagnostics for Accurate and timely Healthcare in Health for all
  3. Quality Benchmarks for entering into Global Markets
  4. Smarter Clinical trials
  5. AMR and GARD-P Best practices for rational use of medicines
  6. Access and Affordability of Orphan and Rare medicines

C. Financing, Legal Landscape & Trade-related Aspects

Sub themes

  1. Reengineering Finance Delivery and Access to Medical Products
  2. IP management and practice, Legal Engagement for access to medical products- licensing options
  3. Non communicable diseases – legal aspects for prevention and promotion of public health
  4. IPR and Trade-related issues in Quality control/ standards
  5. Achieving SDGs: Public Health, IPRs in Bilateral treaties and Regional Agreements

IV. Expected Outcomes

The envisaged outcomes to the Conference are:

  1. Track progress on recommendations of the 1st World Conference 2017 at national and international levels
  2. Engage with a wide set of stakeholders, on critical issues of innovation, manufacturing, regulation, financing, legal, and trade-related aspects for access to medical products in the context of 13th GPW of WHO
  3. Foster new approaches in innovation landscape for medical products and health technologies for accelerating research and innovation including the interface of international trade and health to achieve SDG 2030 goals

V. Venue and Format of the Meeting

The 2nd World Conference 2018 will be organized in New Delhi, India. The three-day conference will consist of an inaugural session, 4 plenary sessions, 12 parallel sessions, 3 wrap-Up Sessions and closing session.

VI. Conference Website

https://www.worldsdg2030.org/

VII. Mobile App

A Mobile App for the conference has been developed to facilitate background resource material in an easy to read mode on an android/smart phone, for ease of accessing documents. Once the participant is registered for the conference on the Website, a link for Mobile-app will be sent to the registered email-ID (both Android/i-OS).

VIII. Participants

The meeting will gather approximately 200 invited participants from international, regional and national levels from the networks of individuals and organizations, such as:

  • Officials and experts from the relevant government sectors such as Ministry of Health, Ministry of Science and Technology, Ministry of Commerce and Ministry of Law and Justice
  • Experts from other countries and WHO regions
  • Participation from Health blocs, e.g. BRICS, SEARO countries etc.
  • UN agencies, WTO, WIPO, World Bank, Welcome Trust, BMGF, World Health Organization
  • Academic experts, Civil society and Private sector

IX. Conference documents

  • Agenda in “Programme Booklet”
  • Session Briefs in “Taking the Agenda Forward Booklet”
  • Position Paper for the Conference
  • Executive Summary and Report of 1 st World Conference 2017
  • Reading Material from previous Conference

X. Supporting Partners

References:

  1. Thirteenth General Programme of Work 2019−2023; http://www.who.int/about/what-we-do/gpw-thirteen-consultation/en/
    • WHA67.20: Regulatory system strengthening for medical products
    • WHA67.23 Health intervention and technology assessment in support of universal health coverage (UHC)
    • WHA68.7: Global action plan on antimicrobial resistance
    • WHA69.11: Health in the 2030 Agenda for Sustainable Development
    • WHA70.7: Improving the prevention, diagnosis and clinical management of sepsis
    • WHA70.12: Cancer prevention and control in the context of an integrated approach
    • WHA71.12: Addressing the global shortage of, and access to, medicines and vaccines
    • WHA71.18: Global strategy and plan of action on public health, innovation and intellectual property
  2. Roadmap for Access 2019‐2023
  3. The 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) focused on patent protection. The 2001 Doha Declaration in WTO emphasized “TRIPs flexibilities” as measures to protect public health.
  4. International trade and health (SEA/RC59/R9); Measures to ensure access to safe, efficacious and affordable medical products (SEA/RC62/R6); National essential drug policy including the rational use of medicines (SEA/RC64/R5); Effective management of medicines (SEA/RC66/R7)
  5. http://www.worldsdg2030.org/