Emergency contraception in Spain refers to the contraceptive methods used in Spain that prevent a fertilized egg from implanting in the uterus. These include the morning-after pill and levonorgestrel. The situation in Spain is unique due to its history of access to contraception in general, the legislative timeline that legalized emergency contraception and under what conditions it could be dispensed, the impact of conscientious objection by doctors and pharmacists, cases in the Spanish judiciary related to conscientious objection, the relatively high cost compared to other countries in Europe and North America, the linkage of emergency contraception with efforts to reduce abortions by both left-wing and right-wing political parties, the impact of the COVID-19 pandemic on the distribution of emergency contraceptives, and usage statistics.
Article 149.1.16 of the Spanish Constitution grants the national government the exclusive right to regulate pharmaceutical products in Spain. Law 29/2006 grants the Spanish Agency of Medicines and Medical Devices (AEMPS) the right to modify conditions relating to prescription and dispensing for reasons related to public health or the defense of health. The distribution of the Emergency Contraceptive Pill (PAU) was authorized by the government led by José María Aznar's Popular Party on 23 March 2001 and its distribution began in May 2001. Policies regarding the use of emergency contraception in public healthcare were left to regional governments, resulting in different policies and levels of access across the country. These differences were clear in 2008. For this reason, in May 2009 the Spanish Government authorized the over-the-counter distribution of ECP-LNG to facilitate women's access to the drug and guarantee its effectiveness regardless of their place of residence, initiating its distribution in pharmacies without a prescription from September of that year. Spain's 2022 reproductive health law, Organic Law 4/2022, also changed how women could access emergency contraception in an effort to decrease abortions and create equitable access across the country. For the first time, national legislation ruled that the pill would be funded by the Ministry of Health, and would be provided free of charge in health centers throughout the country, requiring pharmacies to have emergency contraceptives in their inventories.
Norlevo and Postinor, the emergency contraceptive drugs with levonorgestrel as the active ingredient, were the brands authorized to sell the morning-after pill in Spain from May 2001. EllaOne, with the active ingredient ulipristal acetate (UPA), was approved for use in Spain in December 2009 and was sold as a 30 mg tablet at a cost of €32.78. Between 2001 and 2011, Spain recorded thirty-five adverse reactions and twenty serious adverse reactions in women using emergency contraception. The AEMPS reported in 2012 that the most common side effects of taking levonorgestrel were nausea, headache, dizziness, fatigue, gastrointestinal pain, bleeding, delayed menstruation, heavy menstruation, and increased breast tenderness. There are a number of laws governing the rights of minors related to access to emergency contraception. There are also national laws regarding what medications pharmacies must have in their inventory.
Women throughout Spain have sometimes had problems accessing emergency contraception. Sometimes hospitals had internal policies that denied women access to prescriptions for the morning-after pill. Some hospital doctors were conscientious objectors. Some pharmacies refused to sell it and some pharmacists were conscientious objectors. There were doctors who were reluctant to prescribe it to minors, despite the fact that they could legally do so without a guardian's permission. Many health centers in rural areas were closed on weekends or were not open 24 hours a day. There were women who also faced problems because their doctors required them to have a pregnancy test before administering emergency contraception. The requirement for a medical prescription made access difficult for many women. When it became available over the counter in pharmacies, the cost was often an issue.
Context At the national level, reversible contraceptive methods were decriminalized in Spain on 11 October 1978. In 1983, irreversible contraceptive methods such as vasectomies and tubal ligation were also legalized. Internationally, efforts to create a form of emergency contraception date back to the 1920s, when experiments were first conducted on monkeys. Emergency contraception was created in the 1960s at Yale University to prevent pregnancy after rape. Initially, emergency contraception relied on high doses of estrogen to prevent implantation of an egg. This had too many side effects, so new methods to prevent implantation were sought; in 1984 it was discovered that levonorgestrel (LNG) was the best active ingredient to achieve this and had a higher efficacy rate than ethinylestradiol. The World Health Organization (WHO) declared levonorgestrel an "essential medicine" in 1998.
In September 2009 the drug was available in forty countries worldwide, fifteen of them located in Europe. In 2009, eight countries distributed emergency contraception free of charge and over the counter in pharmacies. They were the United Kingdom, France, Belgium, Denmark, Luxembourg and the United States. Albania, Belgium, Denmark, Slovenia, Finland, France, Great Britain, Greece, the Netherlands, Iceland, Luxembourg, Norway, Portugal, Sweden and Switzerland supplied it without a prescription, and some of them charged for it. Internationally, it was also available without a prescription in pharmacies in 2009 in Aruba, Australia, Benin, Burkina Faso, Cameroon, Canada, China, Congo, French Polynesia, Gabon, Ghana, Guinea-Conakry, India, Israel, Jamaica, Libya, Mali, Mauritania, Mauritius, New Zealand, Niger, Senegal, South Africa, Sri Lanka, Togo, Tunisia and Uganda.
Definition and terms According to the Ministry of Health, emergency contraceptives are medication that prevent a fertilized egg from implanting in the uterus. It acts before implantation to prevent a pregnancy from occurring, so it is not a medication that causes an abortion. The WHO, the Spanish Agency of Medicines and Medical Devices (AEMPS), and the European Medicines Agency all note that it is not abortifacient, nor does it cause abortions. The WHO also considers emergency contraception an "essential medicine" for women's health, and has explained: "Emergency contraception is only effective in the first few days after intercourse, before the egg leaves the ovary and before fertilization by a sperm occurs." However, according to some studies, an abortifacient effect cannot be ruled out.
There are a number of words used to describe emergency contraception in Spain. They include píldora postcoital (), píldora del día después (morning-after pill), píldora del día siguiente (), anticonceptivo de emergencia (emergency contraceptive), anticoncepción de urgencia (), Pastillas Anticonceptivas de Emergencia (), anticoncepción postcoital (), PAU (), PAU-LNG (), ulipristal acetate () and levonorgestrel (LNG).
Authorization and distribution
Article 149.1.16 of the Spanish Constitution grants the national government the exclusive right to regulate pharmaceutical products in Spain. Law 29/2006 regulates the manufacturing guarantees required for medicines intended for human use, and the dispensing conditions of these medicines regulated by the Spanish Agency of Medicines and Medical Devices (AEMPS). It also grants the AEMPS the right to modify conditions relating to prescription and dispensing for reasons related to public health or the defense of health. Royal Decree 1345/2007 was the decree that implemented Law 29/2006, of 26 July.
The distribution of the Emergency Contraceptive Pill (ECP) was authorized by the government led by José María Aznar's Popular Party on 23 March 2001, but policies for its distribution were left to regional governments. The date distribution of ECPs was allowed for use was three months later, in May 2001. The ECP was not among the pharmaceutical products supported by Spain's National Health System, meaning it could be subsidized through social security in any regional health system. The initial cost of emergency contraception for women in a pharmacy was 3,191 pesetas, a profit margin of around 1000%. Before the AEMPS legalized levonorgestrel, an emergency contraceptive method sometimes used off-label cost about 300 pesetas.
In 2008 there were significant regional differences in how emergency contraception was dispensed in Spain based on regional health policies. There was one Spain where regions like Andalusia, Aragon, Asturias, Cantabria, Castile and León, Navarre, Catalonia, Extremadura and Galicia provided emergency contraception free of charge in public health. There was also another where regional governments did not support its distribution, where women with limited income and adolescents had to pay €20 for an emergency contraceptive after receiving a prescription from a doctor. Therefore, in 2009, the Spanish government authorized the over-the-counter distribution of ECP-LNG to facilitate women's access to the drug and guarantee its effectiveness regardless of their place of residence. The decision was supported by a large percentage of doctors. A 2006 white paper from the Spanish Medical Colleges Organization found that 49.61% of medical professionals in Spain were in favor of providing women with emergency contraception without a prescription. It was also supported by an internal AEMPS report conducted in 2008 and presented to the government in early 2009. The announcement of its sale in pharmacies without a prescription was made on 28 March 2009. The Minister of Health, Trinidad Jiménez, defended the sale at an event at the University Hospital of Ceuta as a way to help women avoid unwanted pregnancies and protect their reproductive rights regardless of where they lived in Spain. The original plan was for the drug to be available in pharmacies in August of that year, but it ended up being delayed by a month.
The AEMPS's Medicines Evaluation Committee (CODEM) was convened in July 2009 regarding the change in status of emergency contraception. The advisory committee was composed of several experts, including a member of the General Council of Official Colleges of Pharmacists (GCOF). They worked on the issue from July to September 2009, when the AEMPS finally authorized the over-the-counter distribution of two levonorgestrel brands, the packages in which they would be sold, the leaflets to be included in them and the dispensing conditions. The final report, two resolutions authorizing their sale, was published on 25 September 2009 having been signed by the Deputy Director General for Human Use Medicines of the AEMPS.
At the time the decision was made to do so, there were forty countries in the world doing the same, fifteen of them located in Europe. The Minister of Equality, Bibiana Aído, stated that after the change, pharmacists should sell emergency contraception. The price was set at around €20 if purchased in a pharmacy. Pills purchased in a pharmacy after the 2009 reform came with three leaflets. One was how to use the pill, another dealt with other contraceptive methods, and the last was about how to prevent transmission of STIs such as HIV. In the initial transition phase, some units still had classification information on their boxes saying they were only available by prescription while manufacturers were in the process of changing. There were no changes to this approved procedure in 2009 as of 2012. In 2017, the average cost of emergency contraception in a pharmacy was €22. This compares to €7 in France.