The politics of health technology assessment in Poland.

OBJECTIVE: First, to identify risks associated with the scientific evaluation of drugs considered for state reimbursement in Poland through exploring strategies of influence employed by multinational drug companies in relation to the Agency for Health Technology Assessment (AHTAPol). Second, to ascertain whether the outcomes of drug evaluation meet the interests of the public payer in reimbursing cost-effective drugs supported by robust pharmacoeconomic evidence. METHODOLOGY: We conducted 109 in-depth semi-structured interviews with a purposive sample of stakeholders involved in the reimbursement process in Poland. We analysed four available documentary sources, including recommendations issued by the AHTAPol. RESULTS: AHTAPol recommendations were an instrumental part of the blame avoidance strategy by political elites. Drug producers utilised direct and indirect strategies of influence. The direct strategies involved building relationships with a circle of health technology assessment analysts and medical experts working for the Agency. The indirect strategies employed leaders of opinion in the medical milieu, patient organisations, and political elites to endorse policy positions favourable to drug companies. The AHTAPol positively recommended an increasing proportion of the drugs it assessed, many of them reported as not cost-effective or supported by dubious pharmacoeconomic evidence. CONCLUSIONS: The strategies of influence entail a number of risks that may undermine the scientific evaluation of drugs. Some outcomes of drug evaluation may favour the interests of multinational drug companies over those of the public payer. We suggest that the risks involved in drug evaluation might be mitigated through (1) professionalization of health technology assessment; (2) restriction of job seeking and post public-payer employment; (3) disclosure and management of experts' conflicts of interest; (4) institutionalisation of patient and public involvement; and (5) increased institutional separation of the AHTAPol from political elites.