The World Health Organisation describes emergency contraception or post-coital contraception as methods of contraception that can be used to prevent pregnancy in the first five days after sexual intercourse.
Emergency contraception is intended to be used following unprotected intercourse, contraceptive failure or misuse (such as forgotten oral contraceptive pill, breakage or slippage of condoms), rape or coerced unprotected sex.
Emergency contraception is effective only in the first few days following intercourse before the ovum is released from the ovary and before the sperm fertilises the ovum. Emergency contraception cannot interrupt an established pregnancy or harm a developing embryo.
There are three methods of emergency contraception: emergency contraception medicinal products containing the active ingredients levonorgestrel or ulipristal acetate, insertion of a copper intrauterine device and the method of combined oral contraceptive medicinal products, or the Yuzpe method.
A report published by WHO in 2014 states that “in some countries, emergency contraception is not available on the false grounds that it causes abortion”. Malta is the only country within the European Union where consumers do not have local access to licensed emergency contraception medicinal products.
Medicinal products containing levonorgestrel have been on the Maltese market for over 10 years as the progesterone component in oral contraceptives and intrauterine delivery system indicated for contraception or menorrhagia. In Malta, over 2,000 packs of levonorgestrel containing medicinal products are sold every year.
The Medicines Authority cannot prefer one product over another simply because activists demand so
The use of off-label medicines is possible but is normally reserved to be used in those cases where no other licensed medicines are available. The use of licensed medicines is considered to be safer. Denying the medical profession, pharmacists and consumers the availability of levonorgestrel and ulipristal as a possible safer option to presently used unlicensed methods of emergency contraception in Malta does not make scientific or safety sense.
This is clearly not a case of arguing that two wrongs don’t make a right. The principal duty of the Medicines Authority is to ensure the quality, safety and efficacy of medicines. It regularly seeks the advice of its lawyers and the Attorney General to ensure it functions within the parameters of the laws of Malta.
Doctors prescribe, pharmacists dispense and consumers use a number of contraceptives that could have a greater possibility than levonorgestrel and ulipristal of affecting the endometrium (although definitely not proven in most cases). The motive why activists have created a storm in a teacup in this specific case on bringing on the market Levonelle and EllaOne and not in the case of other products that may affect the endometrium is not understandable.
The Medicines Authority cannot prefer one product over another simply because activists demand so.
The current debate about the introduction of emergency contraception medicinal products on the Maltese market is due to the various interpretations about the mode of action of these products.
The Medicines Authority has presented the summary of product characteristics (SmPC) of Levonelle 1500 microgram tablet (containing levonorgestrel) and EllaOne 30mg tablet (containing ulipristal acetate) in various meetings, including the joint meetings of the parliamentary Social Affairs, Family and Health Committee.
The SmPC is a legal document approved as part of the marketing authorisation of every medicine and it is the basis of information for healthcare professionals on how to use the medicine.
This document also includes a description of the mode of action of the medicinal products as approved by the competent authorities. The information in this document is updated throughout the lifecycle of the product as new scientific data emerges. The SmPC sets out the agreed position as distilled during the course of the assessment process.
The SmPC for Levonelle 1500 microgram tablet containing levonorgestrel, for which the Medicines Authority has, to date, received one application, states that “at the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. Levonelle 1500 is not effective once the process of implantation has begun”.
The centrally-authorised product EllaOne 30mg tablet containing ulipristal acetate was approved by the European Commission in 2009. The scientific evaluation of the marketing authorisation application was carried out by the European Medicines Agency’s scientific committees, including the Committee for Medicinal Products for Human Use (CHMP).
The CHMP plays a vital role in the marketing procedures for medicines in the European Union since it is responsible for conducting the initial assessment of medicines for which an EU-wide marketing authorisation is sought. Members of the CHMP are nominated by each EU member state and are chosen on the strength of their qualifications and expertise with regard to the evaluation of medicines. The assessments conducted by the CHMP are based on purely scientific criteria.
In order for a medicinal product to obtain a marketing authorisation it must meet the necessary quality, safety and efficacy requirements in accordance with EU legislation, particularly Directive 2001/83/EC.
The scientific literature for the EllaOne 30mg tablet has been scrutinised by the CHMP and passed through rigorous checks before authorisation of the medicinal product including the product information. The SmPC for EllaOne 30mg tablet states that “ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator which acts via high-affinity binding to the human progesterone receptor. When used for emergency contraception the mechanism of action is inhibition or delay of ovulation via suppression of the LH surge.”
The product information approved by the scientific experts at European level, based on scientific literature available, clearly shows that the Levonelle 1500 microgram tablet and the EllaOne 30mg tablet do not have an effect on the implantation process. The dossier, with all the technical documentation on the product, was submitted to the regulatory authorities for assessment.
In the decision-making process, the assessment report, together with the product information (SmPC, labelling and package leaflet), were drafted and approved.
A decision on whether the Levonelle 1500 microgram tablet and the EllaOne 30mg tablet should be allowed to be placed on the local market must be taken on purely scientific reasoning. The truth is that there is no scientific reason why the emergency contraception medicinal product is not authorised and accessible to consumers in Malta.
This is a case where one should not call fire where there is no fire. The attitude of calling fire because there is the presence of wood does not make sense. Calling an oral contraceptive abortifacient is similar to calling a fire engine because there is the presence of wood.
It is difficult to envisage a local committee, however bravely nominated, to reach a definite conclusion to classify the mode of action of medicinal products. This locally-nominated committee will need an inconsiderate amount of time and resources to be able to reach a scientifically-valid opinion superior to that determined by the scientific experts nominated by the 28 European competent authorities. The parliamentary committees were already avant-garde in assuming this task themselves.
The way forward should be for all stakeholders to use their efforts, time and media to educate everyone on the proper and safe use of medicines.
Education and more education is the key to a better quality of life for everyone.
Anthony Serracino Inglott is chairman of the Medicines Authority.