The publication of the Regulation on the entry into force of Plan ‘B’ does not automatically mean that women may receive a ‘day after’ pill from 1 May in a pharmacy without prior prescription from a doctor. Prior to the piloting of the pharmacy, the pharmacy must undergo many time-consuming procedures. It is inactive unclear how many of them will decide to do so. Pharmaceuticals note that pharmacies insurers have concerns about compliance by the wellness department with another legal acts.
The ‘B’ plan for access to the ‘day after’ pill was officially announced by the publication of a regulation of the Minister of wellness in the authoritative diary of the Law. This event in the field of reproductive health-related pharmaceutical services, and its content has been somewhat adapted after public consultation. This task was presented by the Minister of Health, Isabella Leszczyna, as a reaction to vetoing the amendment of the Pharmaceutical Law by president Andrzej Duda. Despite insignificant changes in content, the Regulation does not disagree in content from the flawed earlier draft.
Under the fresh Regulation, a pilot strategy is planned to be made available to pharmacies. The main nonsubjective of this programme is to guarantee the availability of emergency contraception for children aged 15 to 18 years.
New government after public consultation
After a public consultation, insignificant changes were made to the Regulation on access to the ‘day after’ pill. The definition of ‘contingent state of reproductive health’ has been added, identifying it as a situation characterised by a abrupt or foreseeable deterioration of wellness in this area. In specified a situation, the pharmacist would be entitled to issue a prescription for the pill.
Under the fresh rules, the pilot programme will include persons who are 15 years old at the date of application to the pharmacy joining the programme. In case of uncertainty about age, the pharmacist will be able to verify it on the basis of a photograph document. In addition, you will be able to usage the pilot program at least erstwhile all 30 days. The cost of interviewing and issuing a pharmaceutical prescription under this program was set at PLN 50.
Prior to that, the pharmacic government expressed concerns about the minimum age of the patient from which pharmacists can legally issue a prescription for a day after.
The Communication stresses that the refusal will not be treated by the NFZ as a "unwarranted refusal to supply services to a patient entitled to a service provided by a pilot under contract, (...) and, as a result, will not constitute grounds for imposing a contractual penalty". The president of the NFZ besides pointed out that, in accordance with the law on the profession of pharmacists, he is independent and independent in deciding on professional activities.
Interest in Pharmacy
The current interest in participation in the program was limited – according to the NFZ until 9 May, only 165 pharmacies from over 12 1000 operating in Poland submitted applications for pilotage.
In 2015, the anticipation of selling emergency contraception pills containing ulipristal acetate (ellaOne) was approved by the European Commission, based on a advice from the European Medicines Agency. In Poland, ellaOne was available without a prescription for people over 15 years of age from April 2015 to July 2017. The regulation allowing free sale was signed by the then Minister of Health, Bartosz Arlukovich. In July 2017, wellness minister in the PiS government, Constanty Radziwiłł, reintroduced a prescription for ellaOne. As a result, Poland and Hungary are the only associate States of the European Union to have a prescription for this kind of contraception.
Exposure of pharmacists to criminal liability
The draft regulation assumes that ‘day after’ pills can be issued without the participation of a doctor, including minors between 15 and 18 years of age. According to him, the release of specified a product, e.g. to a 16-year-old, would be preceded by a pharmaceutical interview on the basis of which the pharmacist would issue a prescription. Although the law allows a pharmacist to conduct specified an interview and to issue a prescription, the conditions of this process do not match those proposed in the draft regulation.
First of all, under pharmaceutical law, a pharmaceutical interview may only apply to products classified as ‘issued without a prescription — OTC’. However, the veto of changes to the law by the president of the Republic of Poland caused that pills “day after” still, in accordance with Polish law, are classified as “issued with a prescription”. The Pharmaceutical Act does not supply for the anticipation of conducting a pharmaceutical interview to choice and issue products in this category, including ‘day after’ pills.
The "day after" pill regulation exposes pharmacists to criminal liability. The draft regulation violates the government on the professions of pharmacists and physicians while violating patients' rights. If the task is implemented, pharmacists may face a threat not only of financial punishment but besides of criminal and professional punishment.
jb
Source: law.pl, newspaperlaw.pl
