[WATCH] Bioethics committee blocked morning-after pill in 2006

Bioethics committee blocked morning-after pill in 2006

An attempt to import the emergency contraceptive Levonelle in 2006 was blocked by the bioethics committee, a consultative committee of scientists, priests and other political appointees, despite the go-ahead of the Medicines Authority, the pharmaceuticals regulator.

Prof. Anthony Serracino Inglott, today head of the Medicines Authority, told MaltaToday in an interview that the regulator had approved the contraceptive for retail in Malta after having analysed the quality, efficacy and safety of the medicinal.

“The authority’s advice was passed on to the superintendent for public health. The latter was subsequently told by the bioethics committee that Levonelle could be considered as an ‘abortifacient’,” a drug causing abortion.

Serracino Inglott said the bioethics committee had reached its conclusion based on the pill’s description that it could affect or interfere with implantation of the egg in the womb.

Levonelle works in three ways: first, it delays the ovaries from releasing an egg; secondly, it prevents the sperm from fertilising an egg that might have been released; thirdly, and this is where pro-lifers raise their most vocal protest, it may interfere with implantation of the egg in the womb.

After the bioethics committee opposed the retail of the morning-after pill, it fell upon Malta’s permanent representative to the European Union, Richard Cachia Caruana, to write to the European Commission citing an EU directive that allows member states to prohibit the sale of products such as contraceptives or abortifacients.

According to Serracino Inglott, the ambassador would go on to justify Malta’s decision to block access by arguing that the Levonelle may interfere with implantation.

“It is not for me to debate whether the bioethics committee was morally, scientifically or philosophically correct in saying that preventing implantation is tantamount to abortion… there are various schools of thought and the role of the regulator is to base its decision on scientific facts,” Serracino Inglott said.

On that, the jury is out as to whether enough scientific evidence proves that Levonelle actually stops the implantation of a fertilized egg. According to the World Health Organisation, emergency contraception is “effective only in the first few days following intercourse, before the ovum is released from the ovary and before the sperm fertilizes the ovum”.

The active ingredients of ellaOne (ulipristal acetate), which is an emergency contraceptive, similar to Levonelle, and Levonelle (levonorgestrel) are already available in Malta, as the main active ingredients of other drugs.

But another importer who requested a licence for the sale of ellaOne was stopped by the Superintendent of Public Health based on the same arguments of the bioethics committee back in 2006. “Since it is similar to the Levonelle, the government assumed that it worked in the same manner,” Serracino Inglott said.

The importation was stopped despite ellaOne’s summary of product characteristics not listing that it interfered with implantation.

Today, an importer does not need to request permission from the Medicines Authority to import ellaOne – a notification would suffice since the drug is already on a centralized register of the EU.

“The law is not, or probably not, against the importation of ellaOne but we would urge an interested importer to give it some time; as a country in which we promote dialogue, society needs to discuss it; we need everyone to understand and learn about emergency contraception and how it works.”

Banning drug ‘draconian’

At a public consultation session last week, Prime Minister Joseph Muscat said that the government was not in a position to stop the importation of ellaOne.

Serracino Inglott opined that a prime minister should not be swayed by public opinion on the matter, warning that such decisions must be based on science and facts.

He was equally of the opinion that banning ellaOne would be draconian, pointing out that the Microgynon 30 contraceptive pill, which prevents implantation, is already widely available in Malta, prescribed by numerous doctors and dispensed by several pharmacies.

“Malta has a right to tell the European Commission it is against emergency contraception, but will it boil down to wanting one brand and not the other? How does one explain to the EU that the authority is in favour of one brand but not the other?”

The Woman’s Rights Foundation, supported by over 100 women, filed a judicial protest seeking to make emergency contraception available in Malta – the only country in the EU where the emergency contraceptive, the ‘morning-after pill’, is not available.

The contradictory – somewhat hypocritical reality – is that while pills like ellaOne are not available, doctors in Malta still prescribe a ‘substitute’.

Esmya (ulipristal acetate 5mg) is used for uterine fibroids – non-cancerous growths of the uterus that often appear during childbearing years – but taking six pills will achieve the same results of an emergency contraceptive, a medical source who chose to remain anonymous, said.

Serracino Inglott confirmed this information.

A doctor’s prescription would suggest that the female buyer is purchasing the medicinal for treatment of fibroids. A box of 30 pills costs €247.

“And, well, decide what you want to do with the rest; perhaps share with a friend or sell them,” Serracino Inglott added, in a sardonic appraisal of the apparently hypocritical reality of Malta’s convoluted medicinal rules.

The Gift of Life Foundation has come out strongly against the morning-after pill, claiming that it is an abortifacient. But Serracino Inglott, an academic pharmacist, argued that pro-lifers’ arguments are only serving to keep up appearances.

“You would be shocked to learn how many women are prescribed Esmya specifically for this use… so is this good? Is this better than ellaOne or are we just promoting hypocrisy?”

Serracino Inglott said he was shocked by the lack of education in the matter: “If there is one thing I learned it is how important education is… from the smallest to the biggest person in society.”

He added that the morning-after pill should not be seen as a routine contraception but – taking after its name – an emergency contraception as a last resort when other forms of contraception fail.

“The World Health Organisation has been unequivocal in that countries banning emergency contraception claiming it to be ‘abortifacient’ are doing a disservice to the community. Can the WHO be harsher than telling countries that their arguments are based on false grounds?”