The morning-after pill without a prescription – will the President of the Republic of Poland sign the amendment to the Pharmaceutical Law?

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Piotr Kłodziński|
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In February 2024, the Sejm began work on an act amending the Pharmaceutical Law, the aim of which is to introduce wide access to emergency contraception (the so-called "morning-after" pill) without a prescription. Currently, such a preparation can only be obtained after receiving a prior prescription (e-prescription) from a doctor. What does the bill already adopted by the Sejm, which is being processed in the Senate and which will require the President's signature, provide? We explain this in this article.

 

The introduction of easier access to emergency contraception was one of the demands of the currently ruling coalition, which wants to increase women's rights related to broadly understood motherhood and pregnancy. Despite the controversy regarding the subject of this act, based primarily on ideological and religious positions, the introduction of such an amendment should be considered both justified and necessary. According to the law, intercourse is actually allowed between people who have reached the age of 15, and thus, indirectly, it "legalizes" getting pregnant by an underage woman. This fact may result in other "rights" under family law. Pursuant to Art. 10 § 1 of the Family and Guardianship Code, a person who is under eighteen years of age cannot enter into marriage. However for important reasons, the guardianship court may authorize the marriage womanwho is over sixteen years of age, and the circumstances indicate that the marriage will be consistent with the good of the established family. According to the literature, "[i]n important reasons, the doctrine includes: having a child or children by the woman and the man concerned by the application; pregnancy of the woman who submitted the application and recognition of paternity by the man to whom the application relates; (…). In court jurisprudence, the applicant's pregnancy dominates among the reasons for granting consent to marry.[1]. Bearing the above in mind, it should be stated that since the possibility of procreation and even marriage for minors is legalized, the possibility of preventing pregnancy itself should be legalized even more.

 

The draft amendment – what exactly does it involve?

The draft amendment to the Pharmaceutical Law is very short - it covers only one page. It aims to repeal section 1a in art. 23a and changes to Art. 96 by adding section 5d, which reads: "If the safety of the use of medicinal products is justified, medicinal products authorized for marketing, indicated in the Summary of Product Characteristics for use in contraception, with the availability category "dispensed without a doctor's prescription - OTC", are issued on prescription, in particular due to on the age of the person for whom the prescription is issued.” and adding paragraph 1 in the following wording: "The minister responsible for health matters may determine, by way of a regulation, the list of medicinal products referred to in section 5d, age or other requirements justifying the issuance of a given medicinal product on prescription, taking into account the health effects of the use of medicinal products, the health safety of patients and the need to create mechanisms to counteract abuses in the use and dispensing of these medicinal products.

 

In order to discuss the proposed changes to the pharmaceutical law, it is necessary to use the text of the justification for the act submitted with its draft. According to its content, the introduction of the amendment in question is intended to eliminate the availability category "dispensed with a doctor's prescription - Rp" for all contraceptives, "even though potentially some of them could remain available for over-the-counter sales (i.e. without a doctor's prescription) without this type of interference." ), because that is how they were admitted to trading.[2]. Nevertheless, in the further part of the justification, the drafter himself emphasizes that this amendment is not intended to enable unlimited access to contraceptives, especially those that are so-called "emergency contraception" - this means making it possible to obtain, without a prescription, a single medicinal product containing ulipristal acetate (ulipristal acetate), which has been authorized for marketing under the centralized procedure (conducted by Decision No. (2009) 4049 of May 15, 2009 by the European Commission) since January 2015 in the availability category "dispensed without a doctor's prescription - OTC". "In the above-mentioned the decision indicated that the effect of this product was the subject of significant preclinical and clinical research, sufficiently justifying its availability category "dispensed without a doctor's prescription - OTC".[3] Strictly speaking, it is precisely about the EllaOne preparation containing the active substance ulipristali acteas 30 mg.

 

Biological justification for the introduced act

The drafter bases the justification for introducing the amendment not only on his beliefs about the need to introduce easier accessibility to the so-called morning-after pills, but also sees it in a woman's biological development. Typically, the menstrual cycle in girls begins at around the age of 12, while achieving hormonal balance, and thus full reproductive capacity, occurs around the age of 15 (not taking into account possible health problems related to hormonal imbalance). As it is easy to notice, "biological maturity" for conceiving children coincides with the legally legalized age of sexual intercourse in Poland. Mothers often take their daughters around the age of 15 to visit a gynecologist, especially if they have a partner, to prescribe hormonal contraception. The current level of social awareness is so high that legal guardians of girls decide to visit a doctor to protect them against unwanted pregnancy, because they are fully aware of the legality of intercourse even at this age. So why not prevent such girls from having access to emergency contraception when they can legally become pregnant, for which they are sometimes not ready not only financially, but also mentally?

Of course, the problem of access to contraception does not only concern young women aged 15-18. Unwanted pregnancies also occur in older women who often cannot afford another child or getting pregnant may cause health complications. The introduction of this amendment will allow such women to feel confident, gain a sense of security and be aware that there is a chance to avoid unwanted pregnancy. What is worth emphasizing here - the so-called morning after pill it is not an abortion or early abortion pill. This effect can only be said when the embryo has already implanted itself in the woman's uterus, while EllaOne is intended to preventing fertilization and implantation of the fertilized egg in the endometrium. This argument should effectively outweigh the positions of opponents of the amendment, who directly identify such preparations with abortion. If commonly used contraceptive pills, prescribed by doctors not only to protect against fertilization, were identified in this way, they would also become the object of attacks by opponents of their use.

The justification for the project also indicated the need to limit the age of access to contraceptives for the population of children and adolescents before the end of puberty, which should be justified only by medical reasons. Once this limit is exceeded, the individual should be allowed to purchase such medicinal products without medical supervision or parental knowledge - "which should not be equated with the thesis that the mere fact of reaching sexual maturity causes the need to use contraceptives."[4]

 

Does the amendment have a chance of coming into force?

As of March 8, 2024, work on the draft amendment to the Pharmaceutical Law is ongoing in the Senate. The bill is awaiting a vote, and if adopted by the upper house, it will be sent to the President for signature and then publication in the Journal of Laws. However, taking into account the President's media statements, it is doubtful that such an act will be adopted at the end of the legislative procedure. According to the President, it is a "hormone bomb" and although he did not expressly comment on the issue of signing the act, such a pejorative reference to emergency contraception allows us to assume a certain probability that the head of state will veto the act.

Nevertheless, this amendment may be adopted by the Senate and then signed by the President. It should be noted here that the existence of the so-called "prescription medicines", although combated by the Supreme Pharmaceutical Chamber and Medical Chambers, makes it easier to obtain the morning-after pill without physical contact with the doctor. There is such a solution de facto identical to the proposed amendment, because obtaining a prescription is currently a simple formality that is not subject to excessive requirements, and the number of prescriptions written in this way is huge. Often prescribed without major problems, standard contraceptive pills also cause many negative side effects in women, although it should be remembered that this is not a medicinal product used in emergency cases, but dosed constantly, sometimes even for several or a dozen years.

The justification for the draft changes to the pharmaceutical law also presents a study on emergency contraception in the European Union and Great Britain. Based on the analysis of 28 countries, it was found that in as many as 26 countries, emergency contraception is available without a prescription, and even in several of them (Belgium, France, Greece, Spain, Ireland, Luxembourg, Portugal and Great Britain) the purchase of such medicinal products is reimbursed by the state. In none of these countries is there any noticeable abuse of morning-after pills, and their easy availability is certainly also an aspect that allows for prudent sexual life, knowing that it is possible to prevent pregnancy without the need to go to a doctor.

Currently, the situation of women in Poland is an extremely difficult topic. For several years, and especially in 2020, there have been many protests in defense of women's rights, including the legalization of abortion (medicated or in the form of a procedure) or increasing access to emergency contraception. Of course, there are positions opposing such actions, and there are certainly some reasons on both sides of this dispute, but unfortunately they are often justified not by medical reasons, but only by ideological or religious reasons. The world has now developed to such an extent that it is necessary to rely not only on our own views, but especially on the voices of medical people who, based on appropriate research, know what is good for humans and what is not necessarily good. Since medicinal products with a specific composition and available without a prescription have been introduced to the market at the EU level, it is even more possible to make the same changes in Polish legislation based on the research that is the basis for such a decision. However, the question of what political decisions will be made regarding changes to pharmaceutical law remains open.

 

[1] A. Stawarska-Rippel [in:] Family and guardianship code. Comment updated, ed. M. Fras, M. Habdas, LEX/el. 2023, art. 10.

[2] P. 1 of the justification for the bill

[3] P. 2 of the justification for the bill

[4] P. 3 of the justification for the project

 

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