New research showed a trouble with clarity of drug approvals in Central Europe

Print 19 January 2018
GMP News

New research, from an international group of health policy experts led by the University of Bath (UK), reports a mixed picture of transparency in public decisions-making around new medicine approvals in Poland, one of Europe’s largest pharmaceutical markets.

Despite a troubled relationship with the European Commission, Poland has been hailed as a leader in modernising its assessment systems in establishing whether new drugs represent good value for money and merit significant public investment.

Drawing on comprehensive analysis of over 330 scientific drug assessments, the new findings suggest that the Polish Agency for Health Technology Assessment has reached the ‘gold’ transparency standard set by the National Institute for Health and Care Excellence (NICE) in England. Surprisingly, the Polish Agency has even exceeded NICE in certain ways, such as providing details of the timing of assessment processes.

But the research finds that scientific assessment reports include a high amount of redacted – or blacked out – information on drug prices, which prevents proper public scrutiny of decisions with huge financial consequences. In addition, the Agency lacks transparency in disclosing potential conflicts of interest of its experts with multinational pharmaceutical giants. It is often unclear how many experts had financial ties to the industry, what their nature was and whether they were appropriately addressed.

The finding is supported by another piece of research, published last month, by the same research group. Based on over 100 interviews and thorough analysis of key policy documents, the study authors identify a ‘Fire Exit’ syndrome, where low-earning civil servants leave public organisations to take up highly paid jobs in the pharmaceutical sector. It also finds a pattern of Big Pharma co-opting medical experts working in an underfunded public healthcare sector using various incentives such as research funding.

The Polish Agency therefore struggles to access expertise which may not be perceived as biased by corporate interests. To make things worse, the Agency is exposed to strong pressure by patient organisations frequently reliant on pharmaceutical funding, in the absence of appropriate state grants.

Lead author, Dr Piotr Ozieranski from the Department of Social & Policy Sciences, explains: “Our research suggests that despite the significant progress made in recent years, the assessment of medical technologies in Poland still has some way to go. Achieving full transparency regarding the nature and extent of potential conflicts of interests of medical experts is a key way of reassuring us, as members of the public, that decisions reached on funding of new drugs are based exclusively on the best possible independent scientific evidence. This is important as in Poland both doctors and patients are exposed to powerful mechanisms of influence deployed by Big Pharma. Increased transparency is an important step in mitigating any undue influence.”

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