Decision on MAP rests with medicines authority, no over the counter sales, committee says

A joint parliamentary committee agreed this evening that the decision on whether to license the Morning After Pill (MAP) should rest with the Medicines Authority.

The decision should be based on recommendations by Parliament and the authority should put national legislation before EU law.

The committee members also agreed that, should the products be licensed, they should not be sold over the counter but only with a doctor’s prescription.

Health Minister Chris Fearne welcomed the recommendations, which were unanimously approved this evening, saying that all members were now of the same opinion. He also said the government had always believed that the decision should be taken by the authority.

The recommendations also include making a distinction between different types of MAP and to allow doctors to serve as conscientious objectors and not prescribe the pill. Furthermore, Malta’s laws on abortion and embryo protection should be respected.

At the start of today’s sitting, former health minister and government whip Godfrey Farrugia presented five recommendations. These said that different forms of MAP have different modes of action and one cannot totally exclude that their mode of action does not preclude implantation of an embryo.

Malta prohibits abortifacients and embryos are protected by The Embryo Protection Act. Dr Farrugia said the EllaOne product and intrauterine devices are “certainly abortive.” The laws of Malta have to be strictly adhered to. He also insisted that, while the Medicines Authority fell under an EU parent entity, it had to give more weight to national law.

Dr Farrugia also said patients seeking to use MAP and IUDs have a right to make an informed, voluntary decision and choose that clinical pathway that safeguards their holistic health. Furthermore, the medical profession has a right to its professional and ethical integrity, and doctors should be free to act as conscientious objectors when deciding whether to prescribe MAP or not. In fact, the Ethics of Medical Practitioners state that ‘a doctor must always bear in mind the importance of preserving life from the time of conception till death.’

Finally, dispensed medication should be a prescription only. Public health issues and the wellbeing of the patients through a comprehensive health care delivery system have to be safe guarded.

He also received correspondence from Professor Anthony Serracino Inglott, the Chairman of the Medicines Authority, who recommended that Levonogestrel (Plan B) pills and Ella should be used legally in Malta but physicians should favour the first. The professor said both should be prescription-only in the first stage, but could later be considered to become pharmacist-recommended medicine. Thirdly, physicians and pharmacists may be allowed to be conscientious objectors to prescribe or dispense all or any emergency contraception, provided that they refer client to a colleague and do not charge for this referral.  Dr Farrugia said he held some reservations.

Health Minister Chris Fearne said it had emerged from the discussions that Levonogestrel  (Plan B) was non-abortive. Therefore it should be made legal in Malta. He also said that distinction had to be made between different forms of MAP and and some of the emergency contraceptives should be also be available over the counter from pharmacies.

Dr Farrugia said studies showed that Ella worked in the same way as the RU468 abortifacient drug and could abort a pregnancy. PN MP Michael Gonzi disagreed, pointing out that the dosage for Ella was much lower than that of RU.

Dr Farrugia said he would prescribe Plan B to a patient only after carrying out an ovulation test, which is 99.9% accurate. “If the test shows that ovulation would have occurred I would not prescribe the morning after pill, as a conscientious objector. The patient would be free to visit another doctor. Doctors should look at the patient’s health in a holistic way and see what is best for them. This is why I believe that community pharmacists should not be able to dispense MAP.”

PN MP Clyde Puli said great emphasis was being placed on the medical and scientific arguments but this issue was also about ethics. A balance needed to be found. He said there seemed to be disagreement even among the top experts and these should be clarified or else this committee would keep going round in circles. He also said that the Medicines Authority, not a parliamentary committee, should decide which forms of MAP were acceptable and which ones were not.

PL MP Deo Debattista said the main aim was to protect life from beginning to end. “From what we have heard one of the forms of MAP is not abortive so this should be available by prescription. But I do not believe that it should be available over the counter because there could be medical implications.”

PL MP Etienne Grech agreed that the decision should rest with the Medicines Authority. He also agreed that MAP should not be available over the counter. He suggested including a recommendation to the effect that doctors should apply the Gillick Principle, which allows them to decide whether they should prescribe MAP to underage girls.

Dr Gonzi said a recent UN report had concluded that neither form of MAP was abortifacient. Dr Godfrey Farrugia retorted by saying that the UN was wrong because it now considered life to start from implantation, rather than fertilization. “They have effectively moved the goalposts – that is why the UN says that they are not abortive.”

Health Shadow Minister Claudette Buttigieg warned that the committee was effectively debating whether a particular medicine should be licensed. This could set a precedent and requests for the licensing of other medicines could be made in future. “What these discussions have proved is that there is wide divergence within this committee. We simply have to hold the medicines authority for abiding by the law. The Embryo Protection Act is clear.”

Dr Paula Mifsud Bonnici said nothing should hold the Medicines Authority from issuing the relevant licenses if its studies concluded that the medicine is non-abortive.


Share Your Thoughts

Your email address will not be published. Required fields are marked *