New developments in the pharmaceutical legislation following the COVID-19 epidemic
The COVID-19 epidemic, rapidly rising in Bulgaria and Europe, as well as the epidemiological measures and state of emergency declared in relation thereto brought rise to various urgent amendments to the pharmaceutical legislation.
Amendments to the Bulgarian legislation
- Several of the amendments were adopted with the Measures and Actions Act during the State of Emergency declared with a resolution of the Bulgarian Parliament on 13 March 2020:
- During the state of emergency public authorities will not initiate public procurement procedures for supply of medical devices, hygiene supplies, disinfectants and personal protective equipment, necessary to ensure the epidemic-control measures, as well as medical devices, medical and laboratory equipment for diagnostic and treatment of COVID-19 patients;
- With regard to the above-mentioned categories of medical devices the rules of the Ordinance on the conditions and order for drafting of the medical devices list under Art. 30a of the Medical Devices Act and for the setting of their reimbursement price (similar to the rules of the Public Procurement Act) will not apply;
- Until the end of the state of emergency and for a period of 2 months after its expiry, pharmacies will be allowed to dispense medicinal products to the chronically ill only with their prescription book and without a prescription (in order to avoid crowding of people-at-risk before general practitioners). Meanwhile, the more detailed rules adopted by the NHIF are counter-effective, since the chronically ill will have to buy their medicines from the pharmacy they bought them last (which could far from the closest to their home);
- Until the cancellation of the state of emergency, the minister of health shall be entitled to restrict the export from the territory of Bulgaria of certain categories of medicinal products. The first of these orders was already adopted – restricting the export of quinine-based products (due to their presumptive therapeutic effect against COVID-19)
- According to a conceptual amendment bill to Ordinance № 10 of 2009, on the rules for reimbursement of medicinal products, the NHIF will pay high-cost oncological medicines at their lowest price between the price achieved during Ministry of Health’s online procurements (of which none has been successfully finished thus far) and the purchase price declared by the healthcare institution, irrespective whether it is a contracting authority as per the Public Procurement Act. The bill is not directly related to COVID-19 or the declared state of emergency, but rather to the recent scandal that private hospitals (which are not required to announce public procurements) purchase expensive medicinal products at a higher value than public hospitals. It is unclear why, only a conceptual draft of the bill was published (and not a bill for public discussion within the meaning of Statutory Instruments Act).
For a brief period, a draft bill was also published on the website of the Ministry of Health on the authorization of generic substitution of medicinal products by pharmacies (substitution of a prescribed branded drug by a different form of the same active substance). Following protests from general practitioners and patient organizations, the proposal was quickly withdrawn (although traces of it could still be found on the Council of Ministers’ website for public consultation)
New developments to European legislation
- The European Commission published a notice that work on a proposal to postpone the date of application for Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices for one year is ongoing. The regulation was to enter into force on 26 May 2020 and aimed at harmonizing European legislation governing the production, certification, marketing and use of medical devices throughout the European Union (currently governed by several directives implemented in the legislation of each Member State). However, the Regulation does not fully codify European legislation on medical devices, as it does not regulate in vitro diagnostic medical devices (in scope of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, to enter into force on 26 May 2022);
According to a press release from the European Medicines Agency, despite the crisis, work is ongoing on the implementation of EU’s Clinical Trial Information System. Its audit is expected to begin in December 2020. Successful completion of the audit is a condition for the entry into force of Regulation No 536/2014 of the European Parliament and of the Council of 16 April 2014. The above regulation governs clinical trials and its main objective is to centralize and simplify regulatory requirements for testing in order to accelerate approval of new and innovative medicinal products. And, as we have learned from the COVID-19 pandemic, sometimes there is nothing more important than the quick approval of new drugs and vaccines.
For further information contact: