Katarzyna Czyżewska is an advocate and partner at Czyżewscy Law Firm, where she is also Head of the Life Sciences. Here she tells Finance Monthly about the pharmaceutical sector and Poland as a location to practice business
What are the most common legal problems encountered by those that operate within the pharmaceutical sector in Poland?
Pharmaceutical companies operating in Poland face serious legal challenges, resulting from the frequent and sometimes broad changes in the pharmaceutical legislation. Only over the last few months the Polish Act – Pharmaceutical Law has been amended three times – and these were serious and comprehensive changes of the law. What is more, the pharmaceutical law is not only regulated by one piece of legislation – important provisions are spread over several acts, regulations or decisions of public bodies.
Adapting your firm’s activities, organisation or internal processes to the never ending amendments of the law requires a lot of regulatory work, time and legal assistance; thanks to that, lawyers specialised in pharmaceutical law in Poland cannot ever get bored with their work.
A special focus of all pharmaceutical companies in Poland is on issues related to pricing and reimbursement. Since 1 January 2012, when a new Act on reimbursement of medicinal products came into force in Poland, the process of obtaining reimbursement of your product from the public funds (and thus, of allowing the therapy with it to be cheaper or free of charge for patients) has become much more difficult than before.
What are the typical liability disputes that arise in Poland?
Many liability disputes in Poland end up before actually filing a lawsuit. This is due to the fact that court proceedings in civil law cases are slow and last for long, and are not so easy for patients. It is a patient who needs to prove before the court (or at least to make it probable) that his or her harm resulted from the therapy with a specific medicinal product and not, for example, from that patient’s disease, other drugs administered to him or her, conditions of treatment in a hospital, etc. Therefore, many patients resign from the court case after approaching a pharmaceutical company at first at realising how difficult the case would be when going to the court.
Nevertheless, pharmaceutical companies do have appropriate procedures of pharmacovigilance adopted and each case, which may concern adverse effects of a drug, are treated seriously and properly notified to the regulatory bodies. If a patient starts to raise financial demands, the best approach of a pharmaceutical company is to collect as much information from the patient, concerning their condition, treatment, etc., as they can; since quite frequently when all the information is collected and analysed, it becomes clear that the causal link between the harm and a drug is very difficult to be found.
What are the common grounds for a medical malpractice lawsuit?
Medical malpractice lawsuits are quite common in Poland and are filed with the courts more and more often. This can be at least partly due to the fact that many small law firms, specialised in such cases, were established in Poland within the past few years; some of them even employ medical consultants to review the cases from the medical point of view.
Majority of cases are filed against hospitals and not against physicians, since it is much easier for the patients to get recovery from the hospitals’ insurance than from a doctor. The Polish law now provides for a special, simplified procedure of obtaining recovery from a hospital insurance policy in medical malpractice cases; although the amount of the potential damages which can be obtained in that procedure is limited and thus, some patients opt for the traditional, long court trial.
Malpractice cases still arise in Poland because the standards of treatment, especially in hospitals, is still not adequate to the patients’ expectations, which can be a source of serious problems of patients. For example, cases concerning malpractice during the childbirth in hospitals are pretty common, due to the fact that some hospitals are trying to limit the costs of those procedures by lowering the standards of medical care during delivery.