Policies and regulations enabling innovation and access to essential health technologies
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Policies, laws and regulations have a direct impact on innovation and access to essential health technologies. National, regional and global policies, laws and regulations can be designed and implemented to promote policy coherence and enhance both research and development and access to essential vaccines, medicines, diagnostics and other health technologies.
“Governments should strengthen national level policy and institutional coherence between trade and intellectual property, the right to health and public health objectives by establishing national interministerial bodies to coordinate laws, policies and practices that may impact on health technology innovation and access.” Source: Report of the United Nations Secretary-General’s High-Level Panel on Access To Medicines, United Nations, 2016
As part of service offerings to strengthen health and development capacities, UNDP responds to requests from countries and provides various kinds of policy, regulatory and legal support, including convening comprehensive and multisectoral reviews of policies, laws and regulations that affect health technologies, disseminating best practices and providing advisory services and technical assistance as needed.
UNDP has supported countries in the Asia-Pacific region, in Eastern Europe and Central Asia, to develop national medicines policies and brings together government officials and stakeholders from different sectors around a common approach. In Myanmar, important legal provisions were added to a new draft Intellectual Property (IP) law to ensure access to affordable essential medicines and greater public participation. In Cambodia, technical support provided for the drafting of a law to enable the government to secure affordable lifesaving medicines. In Eastern Europe and Central Asia, UNDP has provided advisory services on access to essential medicines. In Kyrgyzstan, UNDP supported patent law reform to include agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) -related public health flexibilities and has also advised on access issues in Kazakhstan, Moldova, Tajikistan and Ukraine. UNDP released a comprehensive analysis of the regulatory framework of 11 countries in the region, including registration and licensing of HIV medicines in order to promote sustainable financing of national HIV responses.
UNDP helped countries build the capacities to drive the reforms needed to improve access to health technologies. In South Africa, UNDP has supported work included in the country National Strategic Plan on the pursuit of the law reform recommendations to enable the right to essential and life-saving medicines. UNDP, among other activities, has supported a study on policy options available to South Africa through reform of three interrelated areas of law affecting access to essential medicines: patent; competition; and medicines law.
Through partnerships such as the Access and Delivery Partnership and the Global Health Innovative Technology (GHIT) Fund, UNDP supports both research and development and access to new health technologies for malaria, tuberculosis and other neglected diseases in developing countries. UNDP specifically supports building of national capacities for enabling legal, policy and regulatory frameworks for the introduction of new health products for these diseases.
The work performed by UNDP in policies and regulations is integrated into the national strategic plans for the pharmaceutical sector and the laboratory networks established by the country ministries of health. Procurement of medicines and other health technologies is performed by UNDP in compliance with national laws and regulations.
UNDP has expertise in creating policy, legal and regulatory enabling environments in Low- and Middle-income countries, including comprehensive reviews and proposals to improve and use policies, laws and regulations that influence access to essential medicines and other health technologies.
UNDP networks of expertise include policies, laws and regulations relevant for ministers of health, medicine and other health technologies’ regulators, competition and intellectual property authorities and other relevant authorities and stakeholders.
Pharmaceutical Pricing Policies:
WHO has developed a guideline to assist national policy-makers and other stakeholders at country level in identifying and implementing policies to manage pharmaceutical prices.
Additional WHO guidance on pricing of medicines can be sourced at:
Transparency, Intellectual property and Competition Law:
WHO’s work on intellectual property, including that related to commissions and intergovernmental working groups established within the WHO governance system, can be sourced at:
WHO’s publications related to intellectual property, innovation and trade can be sourced at:
UNDP has developed several practical knowledge tools to assist countries to manage access to medicines and other health technologies. Among these, for example, UNDP has supported the development of the following tools:
The Medicines Patent Pool has established a database on patents for selected categories of medicines (HIV, TB, hepatitis, and other patented medicines included on the WHO essential medicines list):
The Global Fund policy related to compliance with international and national laws, including on aspects related to access to health technologies, is reported in the following booklet: