The Malta Medicines Authority (MMA) said that Levonelle 1500 mcg tablet and Escapelle 1500 mcg tablet containing levonorgestrel, 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.
The MMA said it supports the availability of medicinal products to the consumers and 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.
The currently authorised emergency contraception medicinal products to date are: Levonelle 1500 mcg tablet· Escapelle 1500 mcg tablet· ellaOne 30mg tablet·
Patients and consumers are encouraged to discuss the choice and use of medicines with the pharmacist and/or doctor. These 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.
With reference to the recent comments passed on the World Health Organisation (WHO) and the European Medicines Agency (EMA), the Malta Medicines Authority (MMA) said 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.”
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.' It is worth noting that these two bodies 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.
The MMA as part of the European network for medicines also collaborates with International and European renowned independent authorities. It actively participates at EMA level on recommendations for the authorisation of products on the basis of the assessment and study of the extensive information on the risks and benefits. The MMA has 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.