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In February 2024, work began in the Sejm on a bill amending the Pharmaceutical Law, aiming to introduce broad 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, whose proceedings are ongoing in the Senate and which will require the President's signature, envision? We explain this in this article. The introduction of easier access to emergency contraception was one of the postulates of the currently governing coalition, which wishes to increase women's rights related to motherhood and pregnancy in a broad sense. Despite controversies regarding the subject of this act, primarily located in worldviews and religious stances, the introduction of such an amendment should be considered both justified and necessary. According to the provisions of the law, sexual intercourse is indeed permitted between individuals who have reached 15 years of age, and therefore, indirectly, pregnancy for a minor woman is \"legalised\". This fact may also lead to other \"entitlements\" under family law.<\/p>\n
Under Article 10(1) of the Family and Guardianship Code, a person under the age of eighteen may not enter into marriage. However<\/u> for important reasons, the guardianship court may authorize the marriage woman<\/strong>, who has turned sixteen, and the circumstances indicate that entering into marriage will be in the best interests of the established family. According to legal writings, \" [i]mportant reasons are considered by doctrine to include: the woman and man who are the subject of the application having a child or children; the pregnancy of the woman who filed the application, and the recognition of paternity by the man who is the subject of the application; (...). In court rulings, the applicant\u2019s pregnancy predominates among the reasons for granting consent to marriage.\u201d<\/a>[1]<\/a>. 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. \u00a0 \u00a0<\/strong><\/p>\n The draft amendment \u2013 what exactly does it involve?<\/strong><\/p>\n The draft amendment to the Pharmaceutical Law is very brief, covering only one page. It aims to repeal Paragraph 1a of Article 23a and amend Article 96 by adding Paragraph 5d, which reads: \"For reasons of patient safety for medicinal products, medicinal products authorised for marketing, indicated in the Summary of Product Characteristics for contraceptive use, with the availability category 'available without a prescription \u2013 OTC', shall be dispensed on prescription, particularly with regard to the age of the person for whom the prescription is issued.\" It also adds Paragraph 1, which reads: \"The minister competent for health matters may, by regulation, specify the list of medicinal products referred to in Paragraph 5d, the age or other requirements justifying the dispensing of a given medicinal product on prescription, taking into account the health effects of the use of medicinal products, patient health and safety, and the need to create mechanisms to counteract abuse in the use and dispensing of these medicinal products.\" In order to discuss the proposed changes in pharmaceutical law, it is necessary to refer to the text of the justification for the act submitted with its draft. According to its content, the introduction of this amendment is intended to eliminate the \"available with a prescription \u2013 Rp\" availability category for all contraceptives, \"even though some of them could potentially remain available for over-the-counter sales without this type of intervention (i.e. without a prescription), as they were authorised for marketing in this way.\"<\/a>[2]<\/a>.<\/p>\n However, later in its justification, the author of the bill himself emphasises that this amendment is not intended to enable unrestricted access to contraceptives, and in particular to those known as \"emergency contraception\", but rather to allow for the single medicinal product containing ulipristal acetate to be obtained without a prescription.ulipristal acetate<\/em>), which was authorised for marketing under the centralised procedure (by decision no. (2009) 4049 of 15 May 2009 by the European Commission) since January 2015 in the classification \"over-the-counter \u2013 OTC\". \"The aforementioned decision indicated that the action of this product was the subject of preclinical and clinical studies of significant importance, sufficiently justifying its classification as 'over-the-counter \u2013 OTC'.\"<\/a>[3]<\/a> Strictly speaking, it is precisely about the EllaOne preparation containing the active substance ulipristali acteas<\/em> 30 mg.<\/p>\n <\/p>\n Biological justification for the introduced act<\/strong><\/p>\n The proposer bases the justification for introducing the amendment not only on their conviction about the necessity of making the so-called \"morning-after pill\" more accessible, but also sees it in the biological development of women. Usually, the menstrual cycle in girls begins around the age of 12, while hormonal balance, and thus full reproductive capacity, is achieved around the age of 15 (excluding any health problems related to hormonal imbalance). As it is not difficult to notice, \"biological maturity\" for procreation coincides with the legally legal age of sexual consent in Poland. Mothers often take their daughters to the gynaecologist around the age of 15, especially if they have a partner, in order to prescribe hormonal contraception.<\/p>\n The current level of social awareness is high enough that guardians of girls are deciding to visit a doctor to protect them from unwanted pregnancies, as they are fully aware of the legality of sexual intercourse at such an age. So why not prevent such girls from accessing emergency contraception, since they can legally become pregnant, for which they are sometimes not ready not only financially, but also psychologically? Of course, the issue of access to contraception does not only concern young women aged 15-18. Unwanted pregnancies also happen to older women, who often cannot afford another child or pregnancy may cause them health complications. The introduction of the amendment in question will allow such women to feel confident, gain a sense of security and awareness that there is a chance to avoid an unwanted pregnancy. What is worth emphasising at this point \u2013 the so-called \"morning-after\" pill it is not an abortion or early abortion pill<\/strong>. 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<\/u>Such an argument should effectively outweigh the positions of the opponents of the amendment, who directly equate such preparations with abortion. If commonly used contraceptive pills, prescribed by doctors not only to protect against conception, were equated in this way, they too would become the target of attacks from opponents of their use. The justification for the bill also indicated the need to limit the age at which access to contraceptives is available for children and adolescents before the completion of sexual maturation, which should be justified solely by medical reasons. After crossing this threshold, independence in acquiring such medicinal products should be allowed without medical supervision or parental knowledge \u2013 \"which should not be equated with the thesis that the mere fact of reaching sexual maturity necessitates the use of contraceptives.\"<\/a>[4]<\/a> \u00a0 \u00a0<\/strong><\/p>\n Does the amendment have a chance of coming into force?<\/strong><\/p>\n As of 8 March 2024, work on the draft amendment to the Pharmaceutical Law is underway in the Senate. The bill awaits 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, considering the President's media statements, it is doubtful that such a bill will be adopted at the end of the legislative process. In the President's opinion, this is a \"hormonal bomb\", and although he has not explicitly stated his position on signing the bill, such a pejorative reference to emergency contraception suggests a certain probability of the bill being vetoed by the head of state. Nevertheless, this amendment may be adopted by the Senate and then signed by the President.<\/p>\n It should be noted here that the existence of the so-called \u201ereceptomat\u00f3w\u201d, although fought by the Supreme Medical Chamber and the Medical Chambers<\/a>enables obtaining the \"morning-after\" pill without physical contact with a doctor. This solution is de facto<\/em> identical to the planned amendment, as obtaining a prescription is currently a mere formality that is not subject to excessive requirements, and the number of prescriptions issued in this way is enormous. Standard contraceptive pills, which are often prescribed without major obstacles, also cause many negative side effects in women, although it should be remembered that this is not a medicinal product used in emergencies, but is taken constantly, sometimes for several or even over a dozen years. The justification for the changes in pharmaceutical law also included a study on emergency contraception in European Union countries and the United Kingdom. Based on the analysis of 28 countries, it was established 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<\/strong>Abuse of \"morning-after\" pills is not observed in any of these countries, and their easy availability is certainly also an aspect that allows for a considered approach to sexual life, with the awareness that it is possible to prevent pregnancy without needing to consult a doctor. Currently, the situation for women in Poland is an extremely difficult issue.<\/p>\n For several years, and especially in 2020, numerous protests have been held precisely in defence of women's rights, concerning, among other things, the legalisation of abortion (through medication or surgical procedure), or increased access to emergency contraception. Of course, opposing viewpoints exist, and there are certainly valid arguments on both sides of this dispute, but unfortunately, these are often justified not by medical considerations, but solely by worldview or religious beliefs. The world has developed to such an extent that it is necessary not only to base decisions on one's own views but, crucially, on the input of medical professionals who, based on appropriate research, know what is good for humans and what is not necessarily so. Since medicinal products with a specific composition have been introduced for sale at the EU level and are available over-the-counter, it is even more possible, based on the research underpinning such a decision, to make identical changes within Polish legislation. The question of what political decisions will be made regarding changes in pharmaceutical law, however, remains open.<\/p>\n <\/p>\n <\/a>[1]<\/a> A. Stawarska-Rippel [in:]\u00a0Family and guardianship code. Comment updated<\/em>, ed. M. Fras, M. Habdas, LEX\/el. 2023, art. 10. <\/a>[2]<\/a> P. 1 of the justification for the bill <\/a>[3]<\/a> P. 2 of the justification for the bill <\/a>[4]<\/a> P. 3 of the justification for the project<\/p>\n\n\n
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