The upcoming 2022 is expected to be the year of many new regulations important for the Life Sciences industry. We present four selected proposed changes to the law.
For entities in the medical devices sector, the new regulations on advertising of medical devices will be the next revolution after this year’s start of the MDR application. The bill on medical devices proposes restrictions on their advertising similar to those currently in force in the advertising of drugs, and their violation is to involve the risk of fines of up to PLN 5 million. In addition, the draft introduces a list of distributors, administrative fines in place of the current criminal liability, extending the obligations of medical entities in the use of medical devices and changing the rules for conducting clinical trials and performance tests.
The bill on medical devices was passed by the Sejm on March 9, 2022, and after amendments by the Senate, it returned to the Health Committee. We expect most of the provisions of the new law to enter into force at the end of May 2022.
The draft amendment to the reimbursement act is yet another proposal for changes to the reimbursement in recent years. It proposes changes to the reimbursement procedure (including strengthening the role of the Economic Commission, disclosing the result and course of negotiations with a negative resolution of the Economic Commission, limiting the role of the applicant during the procedure). Moreover, new grounds for discontinuation of the procedure and refusal to cover the refund are to be introduced, reducing the flexibility of the procedure. Polish authorities will be able to make changes ex officio, in particular limit groups, levels of payment for pharmacy drugs and drug programs. Medicines produced in Poland, on the other hand, are to gain preferential reimbursement conditions. The bill has not yet been submitted to the Sejm.
On January 31, 2022, the Regulation on Clinical Trials on Medicinal Products for Human Use (“CTR”) will also start to apply, and for this reason, we also expect the draft law on clinical trials to be passed next year.
CTR will harmonize the assessment and supervision of clinical trials conducted in the EU. The Clinical Trial Information System (CTIS) will contain a centralized database of clinical trials to facilitate research in the EU. The draft act on clinical trials introduces regulations to help implement the CTR. First of all, the Supreme Bioethics Committee is to be established, which will centralize the ethical evaluation of clinical trials and the Fund for the Protection of Clinical Trial Participants, and a separate procedure to obtain compensation for damages caused as a result of participation in a clinical trial. The draft act on clinical trials also systematizes the sponsor’s obligations and proposes changes in the field of non-commercial clinical trials.
Certainly, it is extremely important for all entrepreneurs, including entities from the Life Sciences sector regulating the so-called whistleblowers, i.e. the draft act on the protection of persons who report violations of the law. The draft proposes three reporting channels: internal reporting, external reporting and public disclosure. The definition of a whistleblower is broad, including, inter alia, trainees, volunteers or former employees.
The employer will not be obliged to accept anonymous reports, but will have to implement the Internal Reports Regulations after consulting with trade unions or employee representatives. The whistleblower will be protected even if he makes an external report immediately – in this case also anonymously – immediately submits an external report to the Ombudsman or to the competent public authorities. However, in order to be protected from public disclosure, he will have to make any filings beforehand. The act is to apply to entities employing at least 50 employees. The draft has not yet been submitted to the Sejm, but positions submitted in public consultations were published on December 30, 2021.
Source: Life Science 01/2022 (article updated to the state of April 5.04.2022, XNUMX compared to the original publication)