Levonelle and Escapelle emergency contraceptives authorised for sale

The emergency contraceptive drugs, Levonelle and Escapelle have been authorised for sale in Malta, the Medicines Authority has said. The addition of the two products follows the authorisation of ellaOne last year.

“The Malta Medicines Authority (MMA) is notifying that Levonelle 1500 mcg tablet and Escapelle 1500 mcg tablet containing levonogestrel which are indicated for emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method have been licensed by the Superintendent of Public Health on the recommendation of the MMA in line with Chapter 458 of the Laws of Malta,” read a Medicines Authority statement.

The medicines watchdog said that it supports the availability of medicinal products to the consumers and reminded the public that it provides objective and unbiased information to healthcare professionals and consumers to make informed decisions on the choice and use of medicines. “This enhances the effective, safe and rational use of medicinal products,” it said.

Furthermore, the authority said that while Levonelle 1500 mcg tablet, Escapelle 1500 mcg tablet and ellaOne 30mg tablet have been authorised, it encouraged consumers to discuss their choise and use of medicines with a pharmacist or doctor, adding that the “products are authorised as non-prescription medicinal products as all scientific and regulatory requirements are met.

“The authority would like to thank the Superintendent of Public Health and all stakeholders for the fruitful dialogue throughout this process in the interest of public health.”

Recent comments regarding the WHO and EMA

Reacting to recent comments made on the legitimacy of the World Health Organisation and the European Medicines Agency, the Maltese authority reminded the public that both organisations are “equipped with competent scientific experts and committees who are independent and unbiased decision makers and are well versed in screening evidence based scientific data.”

Speaking yesterday at a talk organised by the Gift of Life Network Foundation, Italian gynaeocologist Bruno Mozzanega insisted that the emergency contraceptive pills are abortifacient and that both the World Health Organisation and the European Medicines Agency are “taking women for a ride” when they claim otherwise.

The Medicines Authority pointed to the following facts which it said were used by the MMA in the presentations to stakeholders:

1. The WHO guidance on integrating human rights considerations into the provision of contraceptive information and services highlights that “in some countries emergency contraception is not available on the false grounds that it causes abortion.”
2. As regards the EMA, the MMA has referred to the Summary of Products Characteristics (SmPC) and the dossier as regards ellaOne 30mg tablet which is authorised by the European Commission. According to the SmPC, ellaOne 30mg tablet is not abortifacient. Section 4.4 of the SmPC of this product states that ‘ellaOne inhibits or postpones ovulation. If ovulation has already occurred, ellaOne is no longer effective.

Moreover, the MMA has said that it shouldered the responsibility and remit placed upon it without fear or favour, in line with the legislation. “In the case of EMA, several European countries amongst them Malta, are enthusiastic about hosting EMA in their countries mainly because EMA is one of the most prestigious European institutions”