Study of methods for state regulation of prices and costs of the health care system for medicines in the United Kingdom

Objective: analysis of state regulation of prices and costs for the purchase of medicines (drugs) in the United Kingdom (UK), and proposal development to improve the processes of state regulation of manufacturers’ marginal registered prices of medicines included in the list of vital and essential drugs approved in the Russian Federation.

Material and methods. Analysis of the structure of state regulation of prices and costs for the procurement of drugs was carried out based on information contained in the regulatory legal documents of the UK Government, health services and technical regulation, and data provided in systematic reviews and articles.

Results. A key feature of regulation in the UK is maximizing the efficiency of health care costs based on the principles of digitization, long-term planning and health technology assessment in pricing. Government regulation of costs is focused on the patent-protected drug segment. Providers of such medicines fall under the Voluntary or Statutory Scheme and are required to make payments in the form of a fixed percentage of sales to the Department of Health and Social Care. Certain drug segments are exempt from payments to stimulate innovative development of the pharmaceutical industry and accelerate market access for new therapies. As practice shows, the Voluntary Scheme is more profitable for most companies. Regulation in the segment of reproduced drugs is carried out by free-market mechanisms and the antimonopoly service.

Conclusion. The analysis revealed the mechanisms and key features of the methods of state regulation of prices and costs of the health care system for the procurement of drugs, identified best practices that are promising for adaptation to improve the state regulation of prices in the Russian Federation. 

1. The Human Medicines Regulations 2012. Available at: https://www.legislation.gov.uk/uksi/2012/1916/introduction (accessed 05.05.2021).

2. The 2019 Voluntary Scheme for branded medicines pricing and access – chapters and glossary. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761834/voluntary-scheme-for-branded-medicines-pricingand-access-chapters-and-glossary.pdf (accessed 05.05.2021).

3. The 2019 Voluntary Scheme for branded medicines pricing and access – annexes. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761835/voluntary-scheme-for-branded-medicines-pricing-andaccess-annexes.pdf (accessed 05.05.2021).

4. The Branded Health Service Medicines (Costs) Regulations 2018. Available at: https://www.legislation.gov.uk/uksi/2018/345/introduction/ made (accessed 05.05.2021).

5. Health Service Medical Supplies (Costs) Act 2017. Available at: https://www.legislation.gov.uk/ukpga/2017/23/contents/enacted (accessed 05.05.2021).

6. Pharmaceutical industry in the United Kingdom (UK) – Statistics & Facts. Available at: https://www.statista.com/topics/5056/pharmaceutical-industry-in-the-uk/#dossierSummary (accessed 05.05.2021).

7. Data from the analytical database of the DSM Group agency. Available at: https://dsmviewer.ru/ (in Russ.) (accessed 05.05.2021).

8. Decree of the Government of the Russian Federation of 31.10.2020 No. 1771 “On approval of the specifics of state regulation of manufacturers' maximum selling prices for medicines included in the list of vital and essential medicines, and amendments to certain acts of the government of the Russian Federation”. Available at: http://publication.pravo.gov.ru/Document/View/0001202011030002 (in Russ.) (accessed 05.05.2021).

9. Decree of the President of the Russian Federation of 07.05.2018 No. 204 “On national goals and strategic objectives of the development of the Russian Federation for the period up to 2024”. Available at: https://base.garant.ru/71937200/ (in Russ.) (accessed 05.05.2021).

10. Decree of the Government of the Russian Federation of 26.12.2017 No. 1640 “On approval of the State Program of the Russian Federation “Development of Healthcare” (with amendments and additions). Available at: https://base.garant.ru/71848440/ (in Russ.) (accessed 05.05.2021).

11. Proposed changes to the Statutory Scheme to control the costs of branded health service medicines. Consultation response. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/871345/consultation-responsestatutory-scheme-2020.pdf (accessed 05.05.2021).

12. Statutory Scheme to control costs of branded health service medicines. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/871361/finalimpact-assessment-statutory-scheme-2020.pdf (accessed 05.05.2021).

13. Methods for the estimation of the NICE cost effectiveness threshold. Available at: https://www.york.ac.uk/media/che/documents/papers/researchpapers/CHERP81_methods_estimation_ NICE_costeffectiveness_threshold_%28Nov2013%29.pdf (accessed 05.05.2021).

14. 2019 Voluntary Scheme sales reports: eligible sales and resulting total scheme payments. Available at: https://www.gov.uk/government/publications/voluntary-scheme-aggregate-net-sales-and-paymentinformation-november-2020/aggregate-net-sales-and-paymentinformation-16-november-2020 (accessed 05.05.2021).

15. Leshkevich A.A., Yurochkin D.S., Golant Z.M., Narkevich I.A. Review of calculation methods, procedures for registration and reregistration of producer prices of medicines in the countries of the Eurasian Economic Union. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / Farmakoekonomika. Modern Pharmacoeconomics and Pharmacoepidemiology. 2020; 13 (2): 193–204 (in Russ.). https://doi.org/10.17749/2070-4909/farmakoekonomika.2020.039.

16. National project “Healthcare”, Federal project “Creation of a single digital circuit in healthcare based on the Unified State Health Information System (EGISZ)”. Available at: https://legalacts.ru/doc/natsionalnyi-proekt-zdravookhranenie-federalnyi-proekt-sozdanieedinogo-tsifrovogo-kontura_4/ (in Russ.) (accessed 05.05.2021).

17. Review of the Branded Health Service Medicines (Costs) Regulations March 2020. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/871228/annual-review-of-the-branded-health-servicemedicines-costs-regulations-2018.pdf (accessed 05.05.2021).

18. Aggregate net sales and payment information: 16 November 2020 (corrected). Available at: https://www.gov.uk/government/publications/voluntary-scheme-aggregate-net-sales-and-payment-informationnovember-2020/aggregate-net-sales-and-payment-information-16- november-2020 (accessed 05.05.2021).

19. Voluntary Scheme for branded medicines: payment percentage for 2020. Available at: https://www.gov.uk/government/publications/voluntary-scheme-for-branded-medicines-payment-percentagefor-2020 (accessed 05.05.2021).

20. Decree of the Government of the Russian Federation of 29.10.2010 No. 865 “On the state regulation of prices for medicines included in the list of vital and essential medicines” (with amendments and additions). Available at: https://base.garant.ru/12179966/ (in Russ.) (accessed 05.05.2021).

21. Decree of the Government of the Russian Federation of 15.09.2015 No. 979 “On amendments to the Decree of the Government of the Russian Federation of October 29, 2010 No. 865 and on approval of the methodology for calculating the maximum selling prices of manufacturers for medicines included in the list of vital and essential medicines” (with amendments and additions). Available at: https:// base.garant.ru/71192234/ (in Russ.) (accessed 05.05.2021).