On 11 September, the official journal published the act of 3 August 2012 modifying the pharmaceutical act of 25 March 1964 in order to include changes regarding pharmacovigilance in the Belgian legal framework, pursuant to Directive 2010/84/EU adopted by the European Parliament and the Council on 15 December 2010 and amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. This law enters into force retroactively on 21 July 2012.
Fund for medical accidents – For more than two decades, Belgium has been trying to create a fund to ensure better and faster compensation of claims against health-care professionals. On 2 April 2010, the law of 31 March 2010 on compensation for damages resulting from health care treatment was published. All damages occurring from that moment on have been subject to potential compensation through the procedure led by the fund that was created at that time. As from 3 September 2012, this fund is active. It will thus have to handle more than 400 pending cases. Consequently, one will have a quick overview of the working process of the fund and of its case-law.
REACH – Be (a)ware of upcoming deadlines – The REACH-regulation is well-known by most stakeholders. Most major players have already registered their products, since the deadline for registration of products imported or produced in quantities greater than 1,000 tons per year, was 30 November 2010. The next deadline is 31 May 2013 and will be applicable to all products and imports of quantities greater than 100 tons per year.
The European Commission has launched a consultation on plans for a public-private partnership in life sciences research and innovation under Horizon 2020. The period of consultation will end on 4 October 2012. According to the Commission, “The consultation seeks key views relating to the launch of a PPP in the life sciences research area under Horizon 2020 and what areas should be addressed”. The consultation is accessible over the internet. http://ec.europa.eu/research/consultations/life_science_h2020/consultation_en.htm
Health practice in Belgium – Number of authorised medical practitioners – On 5 September 2012, the Royal Decree of 1 September 2012 was published. According to this new regulation, the maximum number of people that will be authorised to study for a degree leading to a medical professional qualification, has been adapted. This number is increased for the year 2018 from 1.230 to 2.460. Moreover, new maximum numbers have been established for the years 2019 and 2020.
Recognition of professional qualifications – Belgian regulation has recently been adapted in order to comply with Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications. Therefore, Royal Decree #78 of 10 November 1967 relating to the exercise of health-care professions, has been modified by the Royal Decree of 5 July 2012. The main effect of these new rules is to enforce an administrative practice that had been implemented previously and, therefore, increase the legal certainty regarding those recognitions.