World Health Organization 8 November, 2018 WHO Essential Medicines and Health Products Department Update July – Dec. 2015 IPC Meeting, WHO HQ, Geneva December 10-11, 2015 Kees de Joncheere

EML 2015: Full report available 586 pages, 1082 references http://apps.who.int/iris/bitstream/10665/189763/1/9789241209946_eng.pdf?ua=1

Essential Medicines List 2015 77 applications and a few big challenges: Cancer drugs: a large comprehensive review was commissioned (29 applications) New highly effective HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens) MDR-TB drugs (4) and 1 for TB prophylaxis Rejections: New oral anticoagulants (NOACs), polypill, ranibizumab

World Health Organization 8 November, 2018 Access to medicines and technologies Pricing and HTA: “WHO 2015 Global Survey on Health Technology Assessment by National Authorities” Survey undertaken in response to WHA Resolution 67.23 on ‘Health intervention and technology assessment in support of UHC’ who called WHO Secretariat to assess the status of HTA globally. Report “Developing an approach for using health technology assessments in reimbursement systems for medical products”: Meetings July + Nov 2015, setting HTA agenda Fair pricing forum, planned for 2016 High priced medicines shortages

Access to medicines and technologies Access to Controlled Medicines: 37th Expert Committee on Drug Dependence (ECDD) held in Geneva November 2015. Review of a number of substances with potential for dependence, abuse and harm to health, it makes recommendations to the UN Secretary-General, on the need for and level of international control of these substances. WHO recommends against international control of ketamine.

Efforts towards pharmacopoeial convergence facilitated by WHO WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) Efforts towards pharmacopoeial convergence facilitated by WHO 6th INTERNATIONAL MEETING OF WORLD PHARMACOPOEIAS co-hosted by SFDA/ChPC, Su Zhou, China – 21-23 September 2015 7th INTERNATIONAL MEETING OF WORLD PHARMACOPOEIAS co-hosted by MHLW/PMDA/JP, in Tokyo, Japan - 13-15 September 2016 New Guidance documents adopted by the 50th WHO Expert Committee ECSPP  Finalization of main Good Pharmacopoeial Practices (GPhP)

The International Pharmacopeia 2015 5th Edition of Ph.Int. Just Published in press! Online version: http://apps.who.int/phint/en/

66th WHO Expert Committee on Biological Standardization (ECBS) New Guidance documents adopted Title Brief description Weblink (URL) WHO Guidelines on Good Manufacturing Practices (GMP) for Biological Products (Revised) Major revision. Biocontainment now included for products like poliovirus vaccines. http://www.who.int/biologicals/en/ WHO Guidelines on Stability Evaluation of Vaccines for use under Extended Controlled Temperature Conditions (New) Describes stability evaluation of a specific vaccine when exposed to a planned short term temperature excursion outside the cold chain immediately prior to administration. Avoids off-label vaccine use. WHO Recommendations to assure the Quality, Safety and Efficacy of Recombinant Human Papilloma Virus-like Particle Vaccines (Revised) Revision covers use of immunological endpoints; development of HPV vaccines with extended valency; plus likely entry of new products into the market. Regulatory assessment of approved rDNA-derived biotherapeutics , Addendum to: WHO TRS 987, Annex 4 (New) Regulatory assessment of biotherapeutics licensed with data that do not comply with current international regulatory standards for biotherapeutic products including biosimilars.

WHO Prequalification CPH meeting overview Joint UNFPA-UNICEF-WHO meeting with manufacturers and suppliers of contraceptive devices, in vitro diagnostics, vaccines, finished pharmaceutical products and active pharmaceutical ingredients Forum at which manufacturers, quality, safety and efficacy experts, procurement agencies, and international donors working in public health, come together to discuss issues around production and supply for vulnerable populations Disease updates Presentations of treatment guidelines & market trends Child health Reproductive & maternal health HIV/AIDS, Hepatitis B & C Tuberculosis Malaria Hot topics Data integrity Viable commercial environment Regulatory advice Technical updates Prequalification of MCDs, IVDs, vaccines, FPPs, and APIs Product evaluation for urgent need Collaborative procedure for accelerated registration One-to-one Meetings between technical teams and manufacturers WHO prequalification WHO/UNFPA prequalification Procurement WHO Prequalification of IVDs, vaccines, FPPs, and APIs WHO/UNFPA Prequalification of MCDs

Collaborative procedure WHO Prequalification CPH meeting overview Joint UNFPA-UNICEF-WHO meeting with manufacturers and suppliers of contraceptive devices, in vitro diagnostics, vaccines, finished pharmaceutical products and active pharmaceutical ingredients 357 participants 70 % industry 30% WHO, UN & partners 37 countries 121 one-to-one meetings Vx Rx Dx Assessment Inspection Technical assistance Collaborative procedure Highlight! A new app to: Consult the agenda and speakers Network with attendees Ask questions during the meeting Participate in polls Answer surveys at the end of each presentation

World Health Organization 8 November, 2018 Safety and Vigilance Steering Committee meeting of the Member State Mechanism on SSFFC Medical Products (September, Geneva) Region of the Americas Workshop on Surveillance and Monitoring of SSFFC medical products (October, Buenos Aires) Full meeting and technical meetings of the Member State Mechanism on SSFFC Medical Products (November, Geneva) Medical Product Alerts issued 2015: falsified contraceptive, meningitis vaccine, diazepam 38th Annual Meeting of Representatives of the National Pharmacovigilance Centres participating in the WHO Programme for International Drug Monitoring, November 2015 in New Delhi, India

World Health Organization 8 November, 2018 Regulatory System Strengthening; NRA Assessment Tool 2nd International Consultation (Nov 2015) outcomes: Support for categorizing regulatory systems according to levels of maturity/performance Support for a single WHO benchmarking tool and policy for use by the WHO and/or other organizations that allows for use across product lines (considering smooth transition from current to global tool) Support for WHO efforts to promote a more strategic, effective and coordinated approach to regulatory system strengthening through a coalition of trusted technical partners Support for an abridged tools of regulatory systems benchmarking that takes account the work done by other organizations Recognition that reliance/cooperation is increasingly important in helping to fulfill regulatory mandates

Local Production Technical meeting of Pharmaceutical Manufacturing Plan for Africa facilitated, under the auspices of the AUC On the occasion of the international conference on financing for development in Addis Ababa, Launch of Ethiopia’s National strategy and Plan of Action for Pharmaceutical manufacturing (July 2015): high level representation Prime Minister, Heads of Int. Agencies and WHO DG. WHO Publication on “Cuban experience with local production of medicines, technology transfer and improving access to health”. Global Conference on Assistive Devices & Technology: ASEM Plus in Beijing, Oct 2015.

R&D Blue Print Leveraging lessons learnt for an effective R&D preparedness strategy Developing and implementing a roadmap for R&D preparedness for priority pathogens. Enabling roll-out of an emergency R&D response as early and as efficiently as possible. (Better readiness to promptly conduct R&D during an emergency.)

1 2 3 4 5 R&D Blue Print Five work-streams designed to identify key actions required to accelerate access to products 1 Prioritisation of pathogens & operational plan 2 Identification of research priorities 3 Coordination of stakeholders & expansion of capacity 4 Assessment of preparedness and impact of intervention 5 Development of innovative funding options