Effective medicines regulation protect and improve the health of millions of people every day Dr Olexandr Polishchuk World Health Organization Regional Office for Europe

Draft strategy evaluation (1) Focus of this presentation – pharmaceutical sector It covers only the approach to liberalization of the market and this seams to be considered as panacea.

Draft strategy evaluation (2) Health 2020 http://www.euro.who.int/en/health-topics/health-policy/health-2020-the-european-policy-for-health-and-well-being Health 2020 reconfirms the commitment of WHO and its Member States to ensure universal coverage, including access to high-quality and affordable care and medicines. Medicines are essential for preventing and treating diseases, and poor-quality medicines represent a public health hazard.

Draft strategy evaluation (3) Rational selection and use of medicines EML, clinical protocols, formulary development and update Good prescribing practices Efficient pharmacovigilance system Promotion and advertisement of medicines

Proposals for draft strategy (1) Develop and implement national medicines strategy in line with Health 2020 and Strategy 2020 Ukraine Harmonize medicine’s legislation and regulations with EU norms, standards and practices, WHO guidelines and recommendations Continue capacity building using the existing networks (PIC/S, ICH, PPRI, EUnetHTA, etc)

Resolution В) Support in case of incorporation of substantial amendments (previous slide suggestions but not limited to);