Regulation and Transparency of Drug Prices (MN0054)

Statement of public problem The Plan of Action for the Health Promotion Policy 2020-2026 defines a goal “Provide the population with quality and affordable medicines and medical devices, foster rational consumption” to be achieved by: • Defining the types, price ceilings and copayment ranges for health insurance covered essential medicines; • Strenghening legal and regulatory frameworks for the pharmaceutical industry and its transparency and accountability

Commitment definition ● Meet the demand in affordable essential medicines covered by health insurance ● Establish an integrated digital medicines registry, ensure information transparency Contribution to addressing public problem • Post the insurance covered essential medicines lists on open access websites; • Update the essential medicines list to increase their availability; • Expand the Health Information Management System with content on medicines management to strengthen the substance of public information.

Relevance to OGP values Transparency The essential medicines lists and insurance covered medicines price information will become open; The registered medicines list available on the LICEMED information system for public access; Government accountability Rational medicines consumption information will become open.

Additional information • Regulation of pharmaceutical prices is to be done under the revised Law on Medicines and Medical Devices Funding: • State budget; • Health Insurance Fund. Relevance to other Government programs and projects • The Government Action Plan 2020-2024; • Health Promotion Policy 2020-2026 Target definition • The essential medicines specification list is updated and and information on price ceilings is open for public use. • A reference system of international and domestic prices is introduced in the pricing of insurance covered medicines. Follow-up actions ● Rational medicines consumption content developed and delivered to the public ● Pharmaceuticals price regulations assessed, price regulation provisions updated in the related legislation; ● A reference system of international and domestic prices is introduced in the pricing of insurance covered medicines; ● A practice of using the Medicines Regulation and Customs Office information and data is established.

Milestones Start date: End date: Content development on rational medicines consumption, public information and comunication activities 2022.01.01 2022.05.30 Drug pricing system assessed and modifications introduced in the legislation thereof. 2022.02.20 2023.11.30 A reference system of international and domestic prices is introduced in the pricing of insurance covered essential medicines. 2022.06.30 2023.11.30 The Medicines Regulation and Customs Office information and data integrated in overall information system. 2022.06.30 2023.11.30

Action Plan Review

Commitment 7. Transparency of Medicine and Medical Devices

Results Report

Commitment 7. Transparency of medicine and medical device procurement

Under this commitment, the Ministry of Health conducted regular drug price assessments and convened a cross-ministry working group to discuss relevant regulations and foster collaboration to integrate data. [67] The working group developed a Bill on Drugs and Medical Devices, which, among others, included specific provisions on price ceilings and import mechanisms for medicines and medical devices. However, the process did not involve any civil society representatives and facilitated no opportunities for public feedback. [68] Overall, the ministry was slowed by its focus on the COVID-19 response, making limited progress toward completion of the commitment’s milestones. As the commitment did not have an open government lens, it did not produce notable results in opening government.