2019 World Conference on Access to Medical Products
Achieving the SDGs 2030
19-21 November 2019
Hotel Taj Palace, Diplomatic Enclave
New Delhi, India

I. Introduction

A high-level meeting (UN HLM) on universal health coverage (UHC) was convened by the United Nations on 23 September 2019 on: Universal Health Coverage: Moving Together to Build a Healthier World. The event was an outcome of previous UN General Assembly resolutions 72/139 and 73/131. UHC means that all people and communities receive the quality health services they need, without financial hardship. UHC has an impact on many SDGs including the Goal 3 focusing directly on health. For example, Goal 1 (end poverty), Goal 4 (quality education), Goal 5 (gender equality), Goal 8 (decent work and economic growth), Goal 9 (infrastructure), Goal 10 (reduce inequality), Goal 16 (justice and peace), and Goal 17 (partnerships).

WHO embarked on the 13 th Global Programme of Work 1 (GPW13) for strategic direction in Sustainable Development Agenda 2030 (SDG) for health. The GPW13 is structured around the “triple billion” goal for three strategic priorities for ensuring healthy lives and well-being for all at all ages: achieving universal health coverage (UHC), addressing health emergencies and promoting healthier populations.

Reliable access to effective, safe, quality-assured and affordable medical products (medicines, vaccines, diagnostics, devices) is key to making progress towards UHC and the SDGs.

Access also entails investment in research for new products, especially for health conditions prevalent in low- and middle-income countries. At the same time, public health needs must be protected. In practice, greater capacity to work within intellectual property and competition rules, and use of the TRIPS flexibilities 2 would help improve access for medical products.

The 72nd session of the World Health Assembly adopted a resolution 3 on improving the transparency of markets for medicines, vaccines and other health products in an effort to expand access. The resolution aims to help Member States make more informed decisions when purchasing health products, negotiate more affordable prices and ultimately expand access to health products for the populations.

Assuring access to medical products is key to advancing UHC. The World Health Assembly adopted decision WHA71(8), which led to road map 4 2019–2023 for access to medicines, vaccines and other health products.

In several recent WHA resolutions it has been recognized that health systems need to promote access to medical products (medicines, vaccines, diagnostics, devices) to ensure universal access to health care, improving transparency, rational use of medical products and the sustainability of health systems 5 . 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.

WHO assists Member states for appropriate access to medical products, including policies on access to generic medicines and innovation; quality-assurance of products through effective regulation and promoting rational use of medical products.

In the WHO South-East Asia Region (SEAR), access to essential medicines is a priority in the Regional Flagship on UHC. Access to medicines has been continuously engaging the Member States in the Region. The WHO SEAR Regional Committee has endorsed ten medicines-related resolutions since 2002, of which four are current 6 . The Health Ministers of the Member States of the WHO SEAR, participating in the 71 st session of the WHO Regional Committee for SEAR at New Delhi, India adopted the Delhi Declaration on ‘Improving access to essential medical products in the South-East Asia Region and beyond’ 7.

India’s contribution

India’s contribution towards access to medical products worldwide is well recognized. India is a major manufacturer of medical products and generics. In vaccine manufacturing regulation, re-benchmarking by a team of international experts convened by WHO in 2017 reaffirmed that the Indian National Regulatory Authority (NRA) is well equipped to produce and monitor safe, effective and quality vaccines. WHO prequalification of Indian manufacturers facilitates supply of vaccines to international agencies for procurement; it is also a major breakthrough for vaccine supplies to low- and middle-income countries. India is engaging in scientific progress and R&D for development of affordable products with supportive technology platforms, network of clinical sites and testing facilities, and health technology innovation for meeting critical health needs.

India is actively promoting regulatory collaboration for access to medical products through the South-East Asia Regulatory Network (SEARN) in the Region.

Organisers

As in previous years, the conference will be jointly organized by the Ministry of Health & Family Welfare (MoHFW) and the World Health Organization, and partners: Indian Council of Medical Research (ICMR); Biotechnology Industry Research Assistance Council (BIRAC), a public sector undertaking of the Department of Biotechnology; and Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology, Government of India.

The recommendations made at the two previous World Conferences are being pursued at international and national level by key ministry(ies) in the Government of India.

Access to medical products and creating an enabling legal and trade environment for public health are critical to achieving the SDG Agenda. These issues require regular engagement and dialogue. Given the importance of the agenda, the Honourable Minister of Health, India announced at the 2nd World Conference itself that the 2019 World Conference will be held at New Delhi from 19-21 November 2019.

II. Objective

Accelerating access to medical products for achieving universal health coverage in the context of SDGs.

Specific objectives

The specific objectives are to:

a. Explore new approaches in innovation landscape in medical products for achieving Universal Health Coverage and the SDG 2030 goals

b. Identify regulatory mechanisms for improved access to quality and safe medical products

c. Discuss the role of intellectual property and current trade agreements to promote access to medical products

III. Discussion Themes

The 2019 World Conference will deliberate on access to medical products on the themes of UHC and innovation, regulation of medical products legal landscape and trade-related aspects in the context of access to medical products.

A. Universal Health Coverage and Innovation

Sub themes

  1. Universal Health Coverage-WHO Triple Billion Targets: Moving Together to Build a Healthier World - Follow on to the United Nations General Assembly (UNGA) 2019
  2. Incentives for Development in Antibiotics, Global AMR R&D Hub
  3. Health Technology Assessment as a Tool for Evidence Based Decision Making in Healthcare
  4. Funding and Investments in Medical Products R&D: Role of Data Tracking Initiatives
  5. Controlled Human Infection Model (CHIM) Studies-Regulatory and Ethical Considerations

B. Regulation of Medical Products & Access

Sub themes

  1. Leveraging Regulatory Networks for Access to Quality, Safe and Affordable Medical Products Including Digital Tools for Strengthening Regulatory Systems
  2. Smart Safety Surveillance for Strengthening Pharmacovigilance Systems- Progress Updates and Next Steps
  3. Moving Towards Smarter Clinical Trials– Changing the Paradigm in the Context of Global and Multi Regional Clinical Trials
  4. Medical Technology Pathways for Innovative Medical Devices
  5. Medical Products for End game for HIV/AIDS, Tuberculosis, Malaria
  6. Global Partnerships for Drug Discovery, Innovation and Technology Development: Scaling up Adaptive Technology Solutions for Medical Products
  7. Re-purposing of Medicines for Reduced Approval Timeframe, Decreased Costs and Making Use of Existing Data

C. Legal Landscape & Trade-related Aspects in the context of Access to Medical Products

Sub themes

  1. Patent Landscaping for Health Products (WHA 72/17, 2019)
  2. Licensing and Patents Pool Mechanisms for Medical Products and Health Technologies
  3. Regulatory Approaches for Approval of Pharma & Biosimilar drugs, and Gene and Cell Therapies- USFDA, EMA Models
  4. National Regulation and International Agreements: Role of Regulators

IV. Expected outcomes

The envisaged outcomes are:

  1. Engage with a wide set of stakeholders to explore new approaches in innovation landscape in medical products for achieving Universal Health Coverage and the SDG 2030 goals
  2. Track progress on recommendations of 2018 World Conference at national and international levels.
  3. Strengthen regulatory cooperation and collaboration to improve the quality, safety and availability of medical products.
  4. Promote engagement for public health in trade agreements for accelerated access of medical products

V. Venue and format

The 2019 World Conference will be organized in New Delhi, India. The three-day conference will consist of plenary, parallel & poster sessions and scientific workshops.

VI. Conference Website

https://www.worldsdg2030.org/

VII. Mobile App

A mobile app (both Android/i-OS) for the conference will be available to facilitate accessing background resource material in an easy to read manner. Once a participant is registered, a link for the mobile app will be sent to the registered email-ID.

VIII. Participants

The meeting will be attended by international and national level officials and experts from:

  • Relevant government sectors such as Ministry of Health, Ministry of Science and Technology, Ministry of Commerce and Ministry of Law and Justice
  • Member States
  • WHO and other UN agencies, academia, civil society and private sector

IX. Conference documents

  • Agenda
  • Session briefs
  • Position paper for the conference
  • Executive summary and Report of the 2017 World Conference 2017 and 2018 World Conference
  • Reading material

X. Supporting Partners


Reference

1 Thirteenth General Programme of Work 2019−2023; http://www.who.int/about/what-we-do/gpw-thirteen-consultation/en/

2 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.; WHA 61.21: Global strategy and plan of action on public health, innovation and intellectual property

3 WHA72.8 (2019): Improving the transparency of markets for medicines, vaccines, and other health products (http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8-en.pdf).

4 WHA72.17 (2019) Draft Road Map For Access To Medicines, Vaccines And Other Health Products, 2019–2023 (http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_17-en.pdf)

5 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, Resolution adopted in 72 nd WHA

6 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)

7Delhi Declaration on ‘Improving access to essential medical products in the South-East Asia Region and beyond’ (https://apps.who.int/iris/bitstream/handle/10665/274331/Delhi-Declaration.pdf?sequence=5&isAllowed=y)