UNDP law reform and recommendations of UN High Level panel on Access to Medicines. Presented by Judit Rius Sanjuan, UNDP HIV, Health and Development Group.

1. Judit Rius Sanjuan
UNDP HIV, Health and Development Group
Marrakesh, 16 December 2018
UNDP Law Reform & recommendations of
UN SG High Level Panel on Access to
Medicines

2. UNDP works in nearly 170 countries and territories.
UNDP helps countries develop policies, leadership, partnering abilities,
institutional capabilities and build resilience in order to sustain development results
and achieve the Sustainable Development Goals Agenda 2030.
In all its activities, UNDP encourages the protection of human rights and the
empowerment of women, minorities and the poorest and most vulnerable.
We work with and promote engagement of civil society
UNDP: United Nations Development Programme

3. UNDP has provided policy advice and technical assistance on policy reform and utilization of the
TRIPS flexibilities for more than 10 years:
• We aim to work in partnership with governments, other UN agencies and programs,
multilaterals, academia and civil society
• Our goal is to support countries to address poverty reduction, increase social equity, reduce
exclusion and strengthen governance
As a principal recipient of Global Fund Grants in 18 countries and three regional grants, UNDP
supports governments in developing sustainable approaches to lowering costs and increasing
treatment coverage for HIV and TB, including the use of the TRIPS flexibilities.
UNDP has served as secretariat of two global independent bodies that have recommended the use
of the TRIPS flexibilities to promote access to innovative medicines and save more people’s lives by
reducing costs of treatment:
• The Global Commission on HIV and the Law
• UN Secretary General’s High Level Panel on Access to Medicines
UNDP and Access to Medicines Law Reform

4. Policy & technical co-operation
Upon government requests, UNDP has supported the integration of the TRIPS flexibilities in
national and regional laws and its use:
• Incorporate TRIPS flexibilities into national/regional legislation
• Support countries to incorporate TRIPS flexibilities into national legislation
• Mitigating harmful impact of TRIPS plus commitments
• Convening national working groups on IP and access to medicines
• Use of TRIPS flexibilities
• Training of patent examiners on pro-public health patent examination
• Enabling Inter-sectoral national co-ordination in the issuance of compulsory licenses
• It has included countries and regional bodies of the Southern African Development Community,
East African Community, countries in Latin America, Eastern Europe and Central Asia, South &
Southeast Asia, and the Pacific
• Most recent examples: Ongoing Patent Law Reform in South Africa and Ukraine. November
Malawi Meeting on Policy Coherence in ARIPO Region

5. Knowledge Development & Tools
UNDP has developed several knowledge
products & practical tools that promote the
use of the TRIPS flexibilities, including:
• Guidelines for the Examination of Patent
Applications relating to Pharmaceuticals
• Remuneration Guidelines for Non-Voluntary
Use of a Patent (with WHO)
• Good Practice Guide on Improving Access
to Treatment by Using the TRIPS Flexibilities
• Methodology to conduct patent searches
• Analytical study on impact of 2005 Patents
Act on Indian manufacturers
• Several Policy briefs (with UNAIDS, WHO
and others)

6. Expanding A2M Legal & Policy Tool Box
• A Guidebook for Using Competition Law to Promote Access to Health
Technologies
Policy and technical support to reform laws to promote greater competition in
medicines; National and regional level competition capacity strengthening
initiatives; Inter-ministerial working groups to promote coherence between
government departments and policies on competition law.
Most recently: ASEAN and Fiocruz-ISAGS/UNASUR regional workshops.
• UNDP also leads the Access and Delivery Partnership initiative, established in
2013 and that currently includes WHO, TDR and PATH
The partnership aims to enhance capacity of low- and middle income countries
to access and introduce new health technologies for TB, malaria and neglected
tropical diseases. The partnership is supporting LMICs in a variety of legal
reforms including regulatory pathways, like the African Union model law on
Medical Product Regulations.

7. Selected Recommendations on Law Reform
• Use of TRIPS flexibilities for access recommendations,
including specific reference to patentability criteria and
compulsory license. Importance of Law reform + Strategies
to respond to political process to increase visibility and
response to threats
• Transparency recommendations
• R&D recommendations, including patents, licensing, open
access to knowledge and data & new models for innovation
to ensure public return with both innovation and affordable
access
• Forums for reform: Domestic, Regional and Global
• E.g. The UN Secretary-General should initiate negotiations for global
R&D agreement/s on coordination, financing and development of
health technologies that delinks R&D costs from end prices to
promote access to good health for all
8

8. 9
State of Play : One Year After UNHLP
• UNHLP report has been welcomed by many members states, both by developing and developed
countries. Including Austria, Belgium, Brazil, Colombia, India, Netherlands, Portugal & South Africa.
Government of Thailand, on behalf of G77 and China, at the 2016 UN High-Level Meeting on
Antimicrobial Resistance & 2016 Communique from the BRICS Health Ministers
• The UNHLP recommendations have started to be discussed and implemented in a variety of national,
regional and international forums, including:
– New processes at the UN Human Rights Council and the WTO TRIPS Council, will continue 2018
– Recommendations on new models for innovation included in the 2016 AMR UN Political Declaration
– Spring 2017 WHO & Dutch Government Fair Pricing Forum focus on transparency recommendations
– Chile’s Chamber of Deputies resolution on use of compulsory licenses to increase access to
medicines; Colombia Minister of Health efforts to reduce prices of cancer treatments; and this
November 2017 Malawi’s African meeting to increase access to medicines in ARIPO region
• The year following the report’s release has seen new momentum generated on drug prices and law
reform. For example, in the United States, numerous bills have been introduced at the State and Federal
levels to increase transparency and create government strategies to deal with high medicine prices

9. 10
UNHLP: What is next?
• Continue to be used in processes to increase legal and policy coherence
• Key multilateral negotiations upcoming, including 2018 WHO Executive Board and World
Health Assembly
– Potential for a new WHO roadmap to implement the UN HLP recommendations and
accelerate existing relevant mandates, including WHO Global Strategy and Plan of
Action on Public Health, Innovation and Intellectual Property
• UNGA - Several opportunities to ensure integration of access to medicines & innovation
reforms on ongoing global health UN negotiations, including follow up to 2016 UN HLM
on AMR + upcoming 2018 UN HLMs on NCDs and UN HLM on TB + 2019 UN HLM on
Universal Health Coverage, as well as possibility for a stand-alone UN process on access
and innovation to health technologies
• UN HLP is just another tool. It can be another report or it can a political strategy,
depends very much on you

10. 11
Conclusion
• Comprehensive Tool Box & expand legal reforms:
– TRIPS Flexibilities & pro-public health IP interventions – for access & to remove barriers to innovation
– Competition Law & regulatory frameworks - even more neglected Trade Secrets
– Legal reforms to promote transparency of prices, R&D costs and other key elements
– Legal reform on innovation incentives beyond patents: reform of push and pull incentives by de-linking
R&D costs from prices
• A global priority: The challenges caused by high prices of health technologies and innovation
gaps (eg TB and AMR) are now a priority for many governments around the world, not a
developing country only priority anymore. Legal reform needs to be across technologies
(including diagnostics/vaccines), diseases and countries-income level. UN HLP can be a tool for
global solidarity and action.
• It is important that legal and policy reform is pursued at national, regional and multilateral level
(WHO and beyond) and policy coherence is pursued across all UN agencies and other relevant
institutions to enable comprehensive and integrated strategies as required by the 2030 Agenda