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into New Zealand
Introducing this new anti-progesterone took much longer than expected, 15 years in fact. I first learned about RU486 (as it was then known) at the presentation by the French research team from Roussel-Uclaf at the Fertility & Sterility Conference in Singapore in October 1986. In July 1988 Professor John Hutton, Wellington, returned from the 1st European Congress on Prostaglandins keen to introduce RU486 followed by prostaglandin for early medical abortion. To disseminate this knowledge Professor Baulieu, the French scientist most responsible for the clinical development of RU486, was invited by the New Zealand Family Planning Association to speak in Auckland in November 1990, following his visit to Melbourne.
WHO research was conducted across the Tasman in Sydney and Melbourne in 1994. In June 1995 RU486 was one of the main topics discussed at the inaugural meeting of Abortion Providers in Wellington. In February 1996 Dr Lesley McCowan presented a paper at the RNZCOG meeting in Nelson entitled “RU486 – Why New Zealand should have it”. All of this interest came to nought because Roussel (NZ) refused to introduce the new drug. Their reason? Because of the “adverse climate of opinion prevailing in New Zealand”.
Abortion politics, controversies, protests, commercial sensitivities and threatened boycotts, were all too much and in 1994 Roussel-Uclaf donated the patent rights to the Population Council in the USA. In doing so they requested that the name RU486 be dropped. In the USA mifepristone is known by its trade name Mifeprex. Controversy also halted the research in Australia culminating in the restrictive Harradine Amendment to the Therapeutic Goods Act in May 1996 which prevented further use without ministerial approval.
Notwithstanding previous setbacks a group of experienced abortion providers met in Wellington in February 1997, their aim to introduce a medical option for New Zealand women. First choice was mifepristone, second choice was methotrexate, both followed by prostaglandin. Hopes were raised with the news that Roussel-Uclaf were in the process of transferring the commercial rights to Dr Edouard Sakiz, ex President of Roussel-Uclaf who had been involved with the development of RU486 since its beginning. In August 1997 he formed a small company, Exelgyn, to supply world markets, excluding the USA (which already had patent rights) and China (which manufactures its own and now supplies the USA market).
All options were explored. In the USA the Population Council were sympathetic but they were grappling with medico-legal problems. To source the drug from China would have meant a more difficult path for drug registration. Initially Exelgyn advised that their priority was to supply the existing markets in France (where it was first approved in 1988), the UK (approved in 1991) and Sweden (approved in 1992).
In July 1998 we were encouraged by the response that Exelgyn was now in a position to supply the New Zealand market but only through a reputable pharmaceutical company. With none of the established firms interested, five doctors formed a not-for-profit company Istar Limited which was duly registered in February 1999. Istar was a Babylonian goddess of love, fertility and war, with the appropriate attributes for our venture.
Exelgyn commenced negotiations with Istar and in May 2000 we signed an agreement to import Mifegyne, as packaged for the UK market. The following month we applied to the Ministry of Health for approval of the new medicine. This is always a lengthy process and in our case took over a year. The dossier supplied by Exelgyn and already approved in 21 countries, had to be approved by Medsafe then by the Medicines Assessment Advisory Committee and finally, by the Minister of Health, Annette King who unlike her Australian counterpart was supportive.
On 30 August 2001 Mifegyne 200mg was approved for four indications:
- Early medical termination of pregnancy
- Priming the cervix before a surgical termination
- Second trimester medical termination of pregnancy
- Induction of labour for fetal death in utero
The drug is not available through pharmacies but on a restricted basis to institutions licensed to carry out abortions. It is not available for use as a postcoital contraceptive.
Our first import arrived in September 2001 and Mifegyne was first used in Wellington in October 2001 for a second trimester abortion. It is now used in eight hospitals for this indication and clinicians report favourably on the improved process and the significant reduction of time in hospital.
Clinics were reluctant to use it for early terminations (up to 9 weeks gestation) because of an ambiguity in the New Zealand law which states that all abortions must be “performed” in a licensed institution. Did that mean that the first pill (mifepristone) had to be taken in a licensed clinic? What about the second pills (vaginal misoprostol)? Did the woman have to wait in a clinic for the 48 hours between the two medications? Did she have to wait until the fetal sac had been passed? This was not a problem for later terminations as they are always carried out in a hospital. Initially, only Wellington provided an early termination service on the understanding that if the process was not completed in 6-8 hours, a surgical termination would be carried out. In the first year 63/67 (94%) were successful within the time frame and did not require surgery.
The legal ambiguity needed to be resolved and this was done by taking a case to the High Court. In April 2003 a judge ruled that the two drugs must be taken in a licensed institution but the woman does not have to stay in the clinic for the 48 hours in between nor until the process is complete. With this favourable ruling more clinics are now offering or planning to offer early medical abortions. Standard protocols have been developed from the extensive overseas experience and the Abortion Supervisory Committee has now published clinical guidelines.
Dr Margaret Sparrow is one of the five directors of Istar Ltd, the company which imports mifepristone for use in New Zealand clinics and hospitals.
[Based on article published in O&G Vol 6, No2, May 2004 and available at www.ranzcog.edu.au
Edited September 2004]