In his article regarding the use of levonorgestrel as an emergency contraception, Dr Michael Asciak states that “on or after ovulation, approval or prescription of the high dose drug would lead to breaking Maltese law and the Maltese Constitution. Administrative decisions to that effect would be in breach of the law and the Maltese Constitution.”
This is tantamount to misleading the public that if the Medicines Authority approves the registration of Levonelle it would be breaching the Constitution. Let’s put the public’s mind at rest. The Medicines Authority seeks the advice of the Attorney General in its decisions to ensure that all decisions are within the boundaries of the law and certainly of the Constitution. Dr Asciak should be informed that the Medicines Authority consults the Attorney General whenever there is a need to do so.
Notwithstanding that the Medicines Authority is always open for discussions and consultations with all stakeholders, the Authority does not think it prudent for the Authority to take legal direction from a medical practitioner.
The statements by Dr Asciak that one would be breaking the Constitution only when emergency contraception is dispensed, prescribed or taken “on or after ovulation” does not make scientific sense. It is difficult to see on what scientific basis one can judge whether the medicine has been taken “on or after ovulation”. On what basis is this “expert” going to make this decision?
Dr Asciak spells out the basis whether one is guilty of breaching the constitution or not very clearly when he says that “there are certain times when a doctor could feel that if ovulation has not yet taken place, and this can be ascertained by a two-minute over-the-counter test, circumstances may warrant the use of Levonorgestrel to prevent ovulation and/or fertilisation.”
In the context of the assertions made by Dr Asciak, the following questions arise:
1. Since when has “feeling” been classified as a great scientific method to determine whether one has broken the law and in this case the highest law, namely the Constitution?
2. Since when can a “two-minute over-the-counter test” (the ovulation test) ascertain that ovulation has taken place?
Relying on a two-minute ovulation test to decide without any doubt whether ovulation has taken place or not to date is tantamount to science fiction.
According to Dr Michael Asciak, the Italian system “works beautifully” at least as far as the Bioethics Committee in the context of the availability of the emergency contraception. The Italian system regarding the use of emergency contraception is described by the European Consortium for Emergency Contraception (ECEC) which states that “in Italy levonorgestrel emergency contraception, ulipristal acetate emergency contraception and the use of intrauterine device for emergency contraception are included in guidelines for family planning, and local pharmacies distribute emergency contraception, but emergency contraception is not reimbursed or covered by social security”.
ECEC continues to highlight that “since April 2015, ulipristal acetate emergency contraception is available behind the counter from pharmacies for women who are 18 years of age or older. This means that ulipristal acetate emergency contraception can be bought without a prescription but is not on the shelves of the pharmacy, and needs to be requested to the pharmacy clerk. For women and girls under 18 years old, ulipristal acetate emergency contraception is available only with a prescription. Since October 2015, one brand of levonorgestrel emergency contraception can be dispensed without prescription (behind the counter) to women over 18 years of age.” This means that in this “beautiful system” ulipristal could be dispensed without a prescription before levonorgestrel could be dispensed without a prescription. Is Dr Asciak recommending Malta to follow this beautiful Italian system?
Dr Asciak states that “there is an implicit pun, play on words or trick in the utterances of the Medicines Authority’s chief”. This is hopefully said with tongue in cheek, and it is probably safe to assume it to be so coming from a medical doctor.
In an article on this paper dated 26 June, Dr Asciak said that “ulipristal causes the uterine lining to abort or prevent nidation of any embryo there may be” implying that while levonorgestrel may in certain circumstances not interfere with implantation, the same cannot be said about ulipristal. Following a casual discussion with the chairman of the Medicines Authority, Dr Asciak corrected this impression in a letter to the editor of this newspaper published on 3 July.
In an article published last Sunday, Dr Asciak reversed back to the original idea where he recommends the approval of the use of levonorgestrel before ovulation has occurred and, in spite of his earlier correction, he again excludes the use of ulipristal. How is this continuous change of heart from a statement to a correction back to a restatement within a few weeks coming from Dr Asciak justified? Moreover in this state of mind, one questions the unwarranted remarks gratuitously passed by Dr Asciak on a colleague, the chairman of the Medicines Authority, possibly due to his high emotion on the subject.
Dr Asciak would do well to digest the wise learned words of Professor Mark Brincat, an eminent local scientific obstetrician and gynaecologist with a substantial list of publications credited to his name. Professor Brincat states that “there is not a single peer reviewed publication that demonstrates that emergency contraception leads to a fertilized egg (oocyte) failing to implant, let alone cause an abortion. Expressing doubt is not enough, one has to demonstrate scientifically and actively that such a mode of action takes place. In this case interestingly enough, the very opposite has been demonstrated. The Professor of Law should know that one has to demonstrate that an action has happened in order to allege a crime.”
However, unfortunately, Dr Asciak prefers to quote or misquote statements that he feels adequate to support his views. This is as misleading as those who misquote official documents. For this reason it is worth reproducing verbatim the official mode of action as described in the Summary of Product Characteristics of Levonelle and EllaOne to correct any misquoting of these documents.
The opinion expressed by Dr Asciak on the mode of action of EllaOne is in stark contrast to European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) evaluation of EllaOne mechanism of action.
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 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.”
It is relevant to specify that in this discussion, one is not considering the registration of mifepristone or other products that are used as abortifacients, which Dr Asciak feels necessary to include in his articles, resulting in a mix-up between mifepristone, which could be abortifacient, with Levonelle and EllaOne, which are clearly not.
One final point, it is strange to note Dr Asciak’s objection to the fact that Minister Helena Dalli relies on the opinion of the competent authority to determine whether a drug should be licensed in a country or not. The licensing of medicines in all European countries is in the hands of the competent authorities’ equivalent to the Malta Medicines Authority. The Malta Medicines Authority is very confident of its competences, and this can be claimed through the highly qualified and experienced scientific team it has and whose competence is accepted all over Europe. Therefore it is strange that Dr Asciak objects to the Minister taking up the recommendations of its competent authority.
Prof. Serracino Inglott is the Chairman of the Medicines Authority