The morning-after pill is now available over the counter in many European countries, so why is it still not available here without having to see a doctor first? EITHNE DONNELLAN, Health Correspondent, investigates
A LARGE-SCALE study published in 2006 found 52 per cent of men and 42 per cent of women in Ireland believed the morning-after pill should be available without prescription.
The survey of almost 7,500 people aged 18-64 was commissioned by the Department of Health and the Crisis Pregnancy Agency and carried out by the ESRI and the Royal College of Surgeons in Ireland.
Speaking following the publication of the Irish Study of Sexual Health and Relationships, Minister for Health Mary Harney said it would be a matter for the Irish Medicines Board (IMB) to decide. “There are many arguments for making much medication available over the counter,” she said. “It is more convenient, but clearly it can only be done if it is medically safe to do so.”
Four years on and despite repeated calls from pharmacists and organisations such as the Irish Family Planning Association for the morning-after pill to be made available without prescription here, nothing has changed.
Why is this? The IMB said that “in order to change the prescription status of a medicinal product, the licence holder of that product would have to initiate the process by submitting an application to the Irish Medicines Board. Such an application would be assessed by the Irish Medicines Board and a decision would be taken on whether the prescription status could be amended, or not, following a review of all the scientific data available. The benefits and risks of permitting the wider availability of that medicinal product would be determined, as part of such a review.”
So it’s up to the drug companies, it appears, to apply for an over-the-counter licence for the product, which begs the question why they haven’t done so.
There are two morning-after pills licensed in Ireland at present. These are Levonelle, which is marketed by Bayer Schering Pharma, and NorLevo, which is manufactured by HRA Pharma. It’s estimated the Irish market is worth up to €800,000 a year, with Levonelle, which has been licensed here the longest, having about a 95 per cent market share.
The Irish Timesunderstands that HRA Pharma applied to the IMB in 2007 to have its product licence switched to one that would allow NorLevo be sold over the counter in the Republic. But when the IMB sought further information from the company in relation to its application, HRA Pharma withdrew its request.
It’s not clear why exactly this happened. The company suggested it had to do with lack of demand for an over- the-counter morning-after pill in Ireland at the time. “HRA Pharma distribute NorLevo in many countries across Europe, some of which are prescription-only like Ireland, and others allow direct pharmacy access. We aim to be responsive to the needs of women needing emergency contraception in all markets and we did explore this option previously, but felt there was not the demand at that time. Should that be changing then we will look to respond appropriately,” a spokesman for HRA Pharma UK said.
Bayer, on the other hand, said it had no plans to apply to the IMB to have Levonelle made available over the counter here. “There are no plans at this time to make such an application, but the matter is reviewed from time to time, so this may change,” it said.
Asked why it does not apply now, it said there was nothing to indicate that access to emergency contraception was significantly limited as a result of its prescription status in Ireland. “If this were to change, or if general medical thinking in Ireland were to change, we would again review the status of Levonelle.”
The medical thinking here is mixed. GPs in general believe it should be available only on prescription, but Dr Caitríona Henchion, medical director of the Irish Family Planning Association, said there was no medical reason why emergency contraception could not be made available over the counter here. She said there are some objections, claiming it might increase risky behaviour. “I don’t think that has been borne out by any research in countries where it has been made available without prescription,” she said.
Indeed, a study published in the British Medical Journal in 2005, which looked at use of emergency contraception among women aged 16-49 in the UK between 2000 and 2002 after the morning-after pill became an over-the-counter medicine there, found no significant change occurred in the proportion of women using emergency contraception or having unprotected sex over the period.
As to why drug companies don’t then apply to have it made available over the counter here, Dr Henchion believes they may simply feel it would be unlikely to succeed, that there would be a conservative approach to it. However, she stressed, one could not really condemn the IMB if no drug company applies to have the medicine licensed as an over-the-counter product.
In reality, given that the morning- after pill is available over the counter in many European countries, the IMB could hardly refuse to look favourably on an application to have it made available over the counter in the Republic on safety grounds.
While Bayer suggested there was nothing to indicate access to the morning-after pill was significantly limited as a result of its prescription status in Ireland, some patients see things differently.
Take a recent e-mail from an Irish Timesreader who had been holidaying in Co Clare. "My wife and I have been married for a number of years. During our holidays in Kilkee, Co Clare, we had an accident [a broken condom] and required a morning-after pill. We went to the local pharmacy and were told we needed a doctor's appointment . . . after about an hour we received a call from a doctor's surgery based in Kilrush, about 15km away, with an appointment. We tried to ring our own GP, in Limerick, to see if they could phone in the prescription directly to the pharmacy, but a different doctor was on call over the weekend, who did not know us and was not prepared to phone in the prescription.
“So we drove to Kilrush – luckily we had access to a car – had our appointment, paid the doctor €55 and then purchased the morning-after pill, for about €20. What struck me about this is, if a young girl, say 17-18, had been in the same position, it may have been impossible for her to receive the pill, as she would have needed a car to bring her to the doctor’s appointment, maybe afraid to ask her parents for a lift, and €75 to pay for the treatment [doctor’s fee and pill].
“In such a position, she may decide to take the risk and could end up costing the State €10,000 per annum in welfare costs for the next 18 years, not to mention the impact on her personal life. All because she could not access the pill over the counter, as could be done in the UK. I think this is just another case of rip-off Ireland.”
According to Dr Ronan Boland, a Cork GP who is also chairman of the GP committee of the Irish Medical Organisation, there are pros and cons to the morning-after pill being available over the counter. But he believes that the opportunity to discuss issues around sexual health and a woman’s contraceptive needs with her when she asks for emergency contraception would be lost if it were no longer a prescription-only medicine.
Furthermore, he said, some women may not need it at all when they present, while others will have to be told it may not work. He said a typical GP would probably encounter one woman a year for whom it had failed, as they may “have missed the boat”, and the doctor would have to discuss the possibility with the patient that she might already be pregnant from an earlier risky episode. “There is a concern that many pharmacies in this country are not set up to counsel women on what is a sensitive subject and to take a proper patient history in an appropriate environment,” he added.
Meath pharmacist Kathy Maher rejects this, pointing out that all pharmacies will be required to have private consultation rooms from November. If the morning-after pill did become an over-the-counter medicine in the Republic, “it wouldn’t be a free-for-all”, she said, as there would be clear guidelines on how to dispense it, as in the UK. She said pharmacists were anxious it be made available over the counter to provide more timely access for patients. It had nothing to do with drawing in more customers, she said.
The pharmaceutical industry acknowledges that the process drug companies have to go through to switch medicines from prescription-only to over-the-counter availability had been simplified over the past few years. This may in time have a significant bearing on whether the morning-after pill becomes more freely available.
“While these initiatives should assist companies in making switch applications, the IPHA believes that a partnership approach involving all of the various parties would provide a greater impetus to the switch process, thereby increasing the range of medicines available to Irish patients in a timely and convenient manner,” it said.