What treatment should the sponsor of clinical trials pay for under the new regulations?
Before a new drug is introduced on the market, it is necessary to conduct patient trials. The costs of clinical trials are borne by the sponsor, which is typically an innovative pharmaceutical company. Until recently, under Polish law the obligation to pay for the treatment of patients participating in clinical trials was unclear and controversial. The question was whether the patient had a right to benefits financed by the National Health Fund, or the entire cost of treatment should be covered by the sponsor.
The new rules, set forth in Art. 37k of the Pharmaceutical Law, were introduced by the Act on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products dated 18 March 2011 and have been in force since 1 May 2011. They represent a compromise.
Under the new rules, the sponsor will have to cover the cost of healthcare services that are connected with the clinical trial and covered by the protocol for the study but are not “guaranteed benefits,” i.e. services financed by the National Health Fund from public resources. However, in certain situations the sponsor will also finance services that involve guaranteed benefits, if providing the treatment is necessary for the participant to qualify for the trial, if the necessity to provide the treatment arises from use of the tested drug, or if the treatment is necessary in order to treat complications arising as a result of use of the tested drug.
It is often difficult to demonstrate a causal relationship between use of a drug and the worsened condition of the patient, which means that the last two conditions for the sponsor to cover the cost of treatment are likely to give rise to disputes between sponsors of clinical trials and the National Health Fund. It is also possible that these rules for financing of clinical trials will under further changes, as work is currently underway on a new act, separate from the Pharmaceutical Law, which would govern clinical trials in Poland in a comprehensive manner.
Joanna Krakowiak, Life Science & Regulatory Law practice, Wardyński & Partners
This text was published on 26 May 2011 in the “Commercial Law Academy” series in Dziennik Gazeta Prawna daily