Transparency and Professionalism of Drug Reimbursement Policy
About the chapter:
Transparency Slovakia works to reduce corruption and increase the transparency of institutions. It follows the powerful, pushes for solutions and engages people in public scrutiny. It’s vision is for Slovakia and the world with responsible people and open institutions without corruption.
CPI Score: 50
CPI Rank: 57
View chapter Profile
Theory of Change
Policy & Insititutional ChangeBetter Institutional Processes
Slovakia spent a total of €1.1 billion of public money in 2015 on medicines (reimbursed to health insurance companies). This is more than the annual budgets for the Ministries of Defence and Culture combined.
The categorisation of medicines is a key part of the decision-making process on drug expenditure. The health care system decides whether medicines are subject to full or partial public health compensation.
Given the high level of spending, TI Slovakia has been working to increase the transparency of the categorisation process. It believes that the process should be subject to transparency standards that allow for the widest possible public scrutiny. In particular, scrutiny around the entry of innovative, uncategorised medicines, medical device and dietetic foods.
Annually, the Ministry of Health receives near one hundred requests from pharmaceutical companies and other manufacturers to categorise a new drug, with decisions made by expert working groups on pharmacoeconomics.
TI Slovakia has studied this process with a view to making recommendations designed to improve transparency and accountability.
The analysis included a total of 265 categorisation proceedings. The sample selection was primarily limited by time criterion - proceedings were initiated between 1 January 2013 and 31 December 2015. The second criterion was defined according to the type of procedure - the sample includes inclusion procedures new drug or pharmaceutical form to the categorisation list and official price determination and procedures for the conditional inclusion of a new drug or pharmaceutical form in categorisation list. The proceedings had to give final decisions by 01/08/2016. In the total population, they represented the majority (94%) of new drug inclusion proceedings.
- Declarations of conflicts of interest of advisory group members is missing.
- The decisions are insufficiently justified and do not allow for control or public debate.
- Advisory group membership is free, although they decide millions of euros per year, which increases the risk of bad or corrupt decisions.
- Data on estimates from pharmaceutical companies and other manufacturers are not very reliable, which may undermine the quality of decision-making on funding priorities,
- Introduce professionalisation of the categorisation process, including paid experts and selection proceedings.
- Introduce mandatory public declarations of conflicts of interest for the evaluators of drug applications.
- To publish more detailed minutes on the discussions for/against the inclusion of medicines.
- Control the consumption of newly categorised medicines and the financial impact on the public health insurance as opposed to categorisation assumptions.
- Publish categorisation procedures in a more user-friendly form.