Healthcare Professionals In Spain Call On Government To Switch Contraceptive Pill

Representatives of doctors and pharmacists have met with the director of the Spanish Agency for Medicines and Medical Devices to discuss a position paper which argues enabling OTC access to the daily contraceptive pill will empower women to manage their own reproductive health and improve family planning.

Doctors and pharmacists in Spain have joined forces to call on the government to make progestogen-only daily contraceptive pills available without a prescription.

The Spanish Society of Clinical, Family and Community Pharmacy (SEFAC), the Spanish Society of Primary Care Physicians (SEMERGEN) and the Spanish Society of General and Family Physicians (SEMG) have written a position paper which argues enabling OTC access to the pill will empower women to manage their own reproductive health and improve family planning.

Representatives of the three professional societies on 24 October held a meeting with the director of the Spanish Agency for Medicines and Medical Devices (AEMPS), María Jesús Lamas, to deliver the paper and discuss its main points.

The paper claims that when evaluating the benefits against possible risks based on currently available data, progestogen-only pills should no longer be subject to prescription in Spain.

Allowing pharmacists to dispense the pill OTC, and referring patients to their doctor when necessary, the paper notes, will help remove some of the barriers women face when accessing contraception, while also improving contraceptive success.

Furthermore, OTC availability will contribute to reducing the burden on overstretched general practitioners, freeing up time to deal with more complex health issues.

To support their position, the three societies point to a recent survey of Spanish women aged 18-45 exploring access to daily contraceptives. Of those polled, 52% said they had tried to buy the pill without a prescription on at least one occasion, while 26% had to stop taking it as they were unable to visit a doctor to get a new prescription. Of the women who had to stop taking the pill, six out of 10 considered they had been at risk of pregnancy, and 1 out of 10 had an unplanned pregnancy as a result.

Removing Barriers

María Blasco, coordinator of SEMERGEN’s women's care group, said removing barriers was crucial to improving women's access to the daily contraceptive pill. “Only in this way will women be the sole owners of their sexual and reproductive health. The woman is the only person who should make contraceptive decisions, based on the adequate information provided by health professionals, without access barriers to the contraceptive method that she has chosen.”

The societies met with AEMPS shortly after the publication of a study which found widespread support for OTC availability of a daily contraceptive pill among women and pharmacists in Spain.

Funded by Perrigo’s HRA Pharma, the study was based on a survey of Spanish, German and Italian citizens designed to explore the perceived need and enthusiasm for OTC progestogen-only pills (see sidebar article.)

The recent switch by both HRA and Maxwellia of a progestogen-only pill in the UK has helped to fuel the reclassification debate across Europe.

HRA’s interest in opening up access to the pill is not limited to Europe. In the US, HRA has submitted to the Food and Drug Administration a new drug application to move 0.075-mg norgestrel, branded Opill, from Rx to OTC. (Also see "US FDA Has 10 Months To Provide Answer On Perrigo/HRA OTC Oral Contraceptive Application" - HBW Insight, 11 Jul, 2022.)

However, a decision on the proposal has been delayed. The reason for putting off a joint meeting scheduled on 18 November for the FDA’s Nonprescription Drugs and Obstetrics, Reproductive and Urologic Drugs advisory committees to discuss the application is “new information” the agency needs time to review, according to a Federal Register notice. (Also see "US FDA Requests More Information, Needs More Time To Review Birth Control OTC Switch Proposal" - HBW Insight, 26 Oct, 2022.)