Review: More accountability needed in how drugs are priced and reimbursement

May 24, 2016 | | Say something

Review: More accountability needed in how drugs are priced and reimbursement ;

what the doctor ordered? Credit: Shutterstock

The approval of new medicines reaching the market is the responsibility of the EU, but is left to member states to decide what they wish to subsidize. The new prescription drugs can be very expensive and few patients could afford new drugs for cancer and rare conditions especially if they had to pay out of pocket. But thanks to state subsidies, which pay most of the patients in the EU is only a fraction of the original price, either in the form of a rate flat prescription (as in England) or more levels in patients co- payment, depending on the patient and medicine (as in Poland).

The case of Poland is interesting. In recent years, it has taken many institutional innovations that seek to ensure that makes decisions on pricing and reimbursement sound. However, the new research we have published in British Journal of Sociology found that pricing and reimbursement system Poland (P & R) still lacks transparency and accountability, which allows informal social actors to evade regulations governing conflicts of interest.

EU member states complex policy instruments used to determine how much they are willing to pay the pharmaceutical industry for their products (prices) and what drugs should be prioritized and put within reach of patients (reimbursement). Given the rising abruptly prices of new drugs , P & R has a considerable impact on budgets. In combination with the budgets of finite health (and often declining in real terms), P & R is associated with significant “opportunity costs” and ethical dilemmas, as is depicted brilliantly in the documentary by Andrew Wishard The price of life .

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has long recognized that P & R decisions should be based on solid evidence of drug efficacy, safety, cost-effectiveness and the possible impact on health budgets. This has led to the increasing role of expert advisory bodies such as the National Institute for Health and Care Excellence (NICE) in the UK, conducting scientific assessments of medical, economic and ethical considerations associated with financing new drugs. Politicians and officials involved in the process should also use clear criteria to make their decisions.

The Polish paradox

Poland has been at the forefront of the countries of Central Europe in incorporating the principles of these scientific assessments in its system of P & R. For example, Poland was quick to establish its Agency for Technology Assessment and System tariff , whereas there is no equivalent body in the neighboring, more advanced economically, Czech Republic.

However, the Polish P & R has suffered from persistent irregularities, including scandals lobby , as well as strong Corporate and policy pressures on agency that created. These appear to be part of a general pattern of informal relations in the health sector , including cherry picking winners in public tenders, nepotism and informal payments to doctors. Importantly, those involved in these relationships typically remain unexplained .

Revolving door in other countries. Credit: Nicolas Dan4th, CC BY

Mechanisms ‘denial’

Based on more than 100 interviews with system initiated in Poland, four mechanisms equivalent to what anthropologist Janine Wedel identified policy called “ denial “.

  • We have found evidence of fuzzy boundaries between institutions involved in the policy process. This allowed the politicians, for example, blame controversial reimbursement decisions to bureaucratic or expert advisory bodies
  • Some of the key actors playing roles in different sectors – . public institutions, the pharmaceutical sector or civil society organizations, and sometimes all at the same time. While these “coincidences of interest” to use another term coined by Wedel, reasonably could be seen as controversial, they tended to escape the definitions of “conflict of interest” included in formal regulations.
  • Playing multiple roles allowed stakeholders to maximize their influence by choosing the most suitable hat depending on the situation. For example, some commentators acted as legal advisors “objectives” of the refund policy, while representing pharmaceutical companies in the process.
  • evidence of the activity of elite cliques were identified. Members of these informal groups were able to coordinate their resources and influence, while officially representing different organizations.
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Recent years have seen the introduction of more comprehensive rules governing conflicts of interest. This includes the publication of increasingly detailed sessions leading expert advisory body of the Polish agency and introducing toughened conflict of interest requirements for ministerial advisors best medical protocols. If these improvements address the problem of limited liability depends on whether politicians are prepared to act in the spirit rather than the letter of the regulations, among other things.

These problems are clearly not limited to Poland. For example, in the US and the EU, have expressed concerns about revolving door between drug regulatory authorities and the pharmaceutical sector, as well as some older physicians who act as apparently independent third parties on behalf of the industry . There has also been criticism of the activity of some contract research organizations playing multiple roles in fields ranging from organizing clinical trials for the provision of public relations services for pharmaceutical companies.

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What can be improved?

There are no easy solutions to the problems we have identified. One important way to deal with “coincidences of interest” is through the introduction of a comprehensive reflection period for public officials who leave state institutions. This issue can also be addressed through the ongoing review of policies on conflicts of interest, especially the statements submitted by respondents in the evaluation of medicines to ensure that they reflect the new forms of collaboration with the pharmaceutical industry.

senior officials must also commit to building a culture of transparency, following declarations of conflicts of interest disclosure. There is also a great role to be played by journalists in the framework of the celebration of politicians, public officials and other stakeholders to consider. And there is much to others in the EU to learn about what – and what not – to do, from Poland.

This article was originally published on medicalxpress, Read the original article

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