The first WHO World Local Production Forum ended today after five days of discussions centered on promoting quality and sustainable local production to improve access to medicines and other health technologies.

• Delegates from over 100 countries, international partners, civil society groups, industry associations, and major investors joined WHO, WTO, UNIDO, UNICEF, and UNCTAD to highlight the challenges facing local production and the steps required to address them, as well as the range of opportunities for the sector.

Looking ahead, the Forum will provide a platform to drive forward efforts to support and enhance local production of health products in low- and middle-income countries.

Forum conclusions, recommendations, and next steps

Increasing manufacturing capacity for global security – The COVID-19 pandemic has highlighted the importance of local manufacturing as a key component of pandemic response by reducing reliance on global markets and imported products.

Vaccine production was a central theme at the Forum, as were the role of new technologies and the generation of flexible manufacturing strategies to develop sustained production capacity in low- and middle-income countries.

Technology transfer and licensing were seen as key to scaling up production. Sharing intellectual property and know-how will be essential, along with the facilitation of voluntary licensing and effective technology transfer. It will also be vital to create a favorable environment for technology transfer. Key elements will include good governance; a skilled workforce; good access to market information and careful assessment of local capacity to receive and absorb the transferred technology.

Governments’ role is key in creating an enabling political environment and a supportive business ecosystem. Such efforts must be coordinated with relevant stakeholders at national, regional, and global levels.

National regulators and local manufacturers can drive quality-compliant local production and facilitate faster access to health technologies during pandemics and beyond.  To do that, they need continued training, support, and resources.

Low access to capital is a key limiting factor for local manufacturers in low- and middle-income countries. The greater interest expressed by key development banks and other financial institutions towards investing in the sector indicates improvement in this area, whilst the need to develop strong investment cases, including demonstration of a long-term economically viable business case, were highlighted as key components of successful manufacturing projects.

A mechanism to stimulate industry engagement was recommended for strengthened collaboration with and among industry bodies with the aim of transferring priority technologies to low- and middle-income countries.

A strategic advisory group should be established by WHO in collaboration with Member States and partners to address current and future global challenges and trends in local production and technology transfer.

The next Forum will be held in The Netherlands as announced by Deputy Prime Minister and Minister of Health, Welfare and Sport, Hugo De Jonge. The Local Production Forum is now established as a long-term mechanism to promote dialogue and decision-making to strengthen local manufacturing capacity and move towards the shared goal of universal access to health technologies.

Source: www.who.int

New WHO Guidance for country validation of viral hepatitis B and C elimination is released during a joint EASL-CDC-ECDC and WHO symposium “Viral Hepatitis Elimination – Assessing the progress in 2021” at the EASL International Liver Congress 2021. This represents the first-ever global guidance for countries seeking to validate the elimination of hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection as a public health problem.

In 2016, the WHO Global Health Sector Strategy (GHSS) on viral hepatitis provided the initial roadmap for the elimination of viral hepatitis as a public health problem by 2030 – a 90% reduction in incidence and a 65% reduction in mortality by 2030, compared with a 2015 baseline. This new guidance provides a framework for countries to measure their efforts in reducing both new infections of hepatitis B and C and deaths from liver cirrhosis and cancer alongside reaching high coverage (>90%) of program interventions to ultimately confirm attainment of elimination. These include preventative interventions, such as hepatitis B infant and birth dose vaccination, blood and injection safety and harm reduction, as well as HBV/HCV, testing and treatment, and must be maintained for 2 years. This interim guidance aims to promote a standardized public health approach for viral hepatitis elimination and recognizes regional and country context and burden of viral hepatitis B and C.

Countries are encouraged to pursue the elimination of both viral hepatitis B and C together, however they may choose to apply separately for one of four certification options:

• Option A: elimination of mother-to-child transmission (EMTCT) of HBV (as part of triple elimination of HIV, syphilis, and HBV, or HIV/HBV).
• Option B: HCV as a public health problem;
• Option C: HBV as a public health problem (including HBV EMTCT); and
• Option D: Elimination of both HBV and HCV together as a public health problem.

The guidance also provides countries with a range of options for how to measure the targets depending on available surveillance data and capacity, as well as a checklist of other considerations to assess their progress towards elimination. These include assessing the quality of strategic information, laboratory processes, diagnostics and medicines, and health-care programs, as well as adherence to the principles of equity, human rights, and community engagement.

WHO already has an integrated approach to the elimination of mother-to-child transmission (EMTCT) of HIV, syphilis, and hepatitis B pioneered jointly by the Pan American Health Organization, and the Regional Office for the Western Pacific Region. WHO also has strategies and targets for the elimination or eradication of 30 other diseases. Where possible, the process for validation of elimination of viral hepatitis can be aligned. with these other disease elimination efforts to promote system efficiencies.

“This guidance is intended to motivate countries to take rapid and appropriate action toward viral hepatitis elimination. It is also important that the validation process is country-led and driven. There are important differences across countries in their hepatitis B and C epidemics, and they will need to adapt the process and national targets to their context and affected populations,” said Dr Meg Doherty, Director of WHO’s Global HIV, Hepatitis and Sexually Transmitted Infections Programmes.

“The guidance is a valuable practical tool for countries seeking to achieve elimination of hepatitis B and C. The epidemiology and progress toward elimination vary by country, and this document provides the flexibility for countries to adapt it to their context” said Dr Carolyn Wester, Director, Division of Viral Hepatitis, Centers for Disease Control and Prevention.

“To overcome the barriers to achieving viral hepatitis elimination, we must improve people’s access to treatment and care. To this end, all actors involved, including patient organizations, must work together and deliver care at the community level. In 2019, the major hepatology societies agreed that there is an urgent need to simplify viral hepatitis testing and linkage to care and today this remains a priority. Only by decentralizing viral hepatitis services to local level care and task-sharing care with primary care clinicians and other health care practitioners, we can achieve our goal,” said Maria Buti, Chair of EU Policy and Public Health, European Association for the Study of the Liver (EASL).

Source: www.who.int