Tech & Rights

Ask the Authorities about Risks and Side Effects

Developments in access to the abortion pill in Hungary make for an interesting story. Though the licensing procedure for medicines is never transparent, the process surrounding the pill is even more complicated.

by Hungarian Civil Liberties Union

Through a public interest data request, we acquired some documents that had long been kept from the public, allowing us the opportunity to provide a short review of what has happened in this matter during the last decade. In 2005, the pill was included in the List of Vital Medicines and its introduction was supported by the Hungarian Obstetric and Gynecologic Professional Board. Their decision was justified by claiming that nothing in fact supports prohibition, and that in cases when the use of the pill is advised, it has fewer negative effects on women’s bodies compared with artificial abortion. A fundamental principle of medical ethics is that of primum non nocere, that is, "first, do no harm." Even though artificial abortion qualifies as a relatively safe intervention, any kind of intervention involves certain risks. The principle mentioned above requires that the risks are reduced to a minimum; in other words, when surgery can be avoided, the pill should be made available.

It is important to note that administration of the pill was planned to occur only in a controlled hospital environment, according to current abortion regulations. The only difference would have been the restriction of the use of the pill to the first eight weeks of pregnancy, due to medical considerations. By contrast, artificial abortion, as a rule, can be applied according to Hungarian law until the 12th week, unless it is made necessary by medical reasons.

Despite the support it had, the registration of this medicine occurred only as late as May of 2012, based on the request of a Dutch company submitted back in 2009. Registration was accomplished in the framework of a so-called decentralized procedure, meaning that the process was taking place in several EU member states simultaneously (in this case, among others, the Czech Republic, Denmark and Romania). There is always a reference country – in this case Sweden – and if the medicine under consideration becomes licensed there, licenses must be automatically granted in all the other states participating in the process. Hence, the pill is now safely used in Sweden and Denmark; furthermore, it had already been accessible years before in several other EU countries, such as France and the United Kingdom, as well as in Hungary’s neighboring state, Austria.

The body authorized to conduct licensing procedures in Hungary is the National Institute for Quality and Organizational Development in Healthcare and Medicines – National Institute of Medicine (abbreviated in Hungarian as GYEMSZI-OGYI). In a decision of 17 May 2012, authorities in the reference country and the other participating states unanimously affirmed that the medicine’s so-called benefit-risk factor is favorable, its effects have been clinically proven, and it fully complies with Hungarian legal regulations. Thus Hungary’s only obligation was to ensure that the application of the medicine is in accordance with current abortion law, as well as the relevant directives of the Obstetric and Gynecologic Professional Board. Only one move was missing to actually introduce the use of the pill: its adoption by the National Health Insurance Fund. This has not happened. The aim of the adoption procedure is to license the use of health technologies and to define whether a medicine will be publicly financed and to what extent. It should be noted that the Hungarian law regulating this procedure derives from the country’s legal harmonization obligations and its compatibility with a Council Directive aiming at the transparency of the licensing procedure of medications.

This is the point where the story becomes really interesting. We have the professional statement from 2005 supporting the use of the pill and prescribing medical supervision as well as compulsory consultation, along with other legal conditions. Therefore, the planned method of administering the pill would have met all the criteria, and yet, following the licensing order, the State Secretariat for Healthcare issued a statement stating that the “risks involved are still subject to debate."

With our public interest data request, we wanted to find out about the risks discovered by the state secretariat that remained unnoticed by the WHO, the various medical experts who have studied the pill and the licensing bodies of the many other EU countries currently allowing use of the pill. In response to our initial request, GYEMSZI-OGYI refused to provide any data, which we found unacceptable, since the form of our data request contained an exemption for any illicit contents. Therefore, we brought our case to court, requesting the provision of data. With reference to exceeding the deadline, we lost the case, as the period allowed for the procedure was calculated in an unusual way. Again, we turned to GYEMSZI-OGYI asking for a clarification of the authority’s decision and information concerning impact analyses and “debated risks." This time we gained access to the decision to close the public administration procedure and the report on public evaluation. All these documents show is that the appropriate procedures and risk analyses have been conducted and it was concluded that the use of the pill is safe and effective. GYEMSZI-OGYI did not provide us with any documents indicating the source of the debate about risks and side effects.

It is still a mystery as to what the risks in the controlled application of the pill are. Obviously, the matter concerns only the health risks involved for women using the pill – why should anyone assume that other considerations are in the background?

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