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from the official Belgian proposal for implementing EU directive 2001/20/EC into national legislation
Chapter II: DEFINITIONS AND FIELD OF APPLICATION
15* “non-commercial experimentation”: any experimentation in which:
a) the sponsor is a university, a hospital as intended by article 4, paragraph 2 of the law of 7 August 1987 on hospitals, the “National Fund for Scientific Research” or the “Fund for Scientific Research” or a research fund that is answerable to one of these two bodies, or another body approved for this purpose by the application of article 31 of the present law;
b) the holder of the patent for a medicine or the registered trade mark of a medical device that is the subject of the experiment being conducted is not, either directly or indirectly, the sponsor of the research;
c) the sponsor exercises intellectual property rights over the design of the experiment, its execution and the scientific data that derive from it.
Chapter XIII: LABELLING OF EXPERIMENTAL MEDICINES
Article 25
The King determines the information that must be given, in at least the three national languages, on the outer packaging of experimental medicines, or in the absence of outer wrapping of the experimental medicines, on the primary pack.
He also determines the appropriate requirements for the labelling of experimental medicines intended for clinical trials that have the following characteristics:
1* the design of the trial does not require any particular manufacturing or packaging,
2* the trial is conducted with medicines that, in the Member States involved in the trial, have received authorization to market, and are manufactured or imported in accordance with the provisions of the above-mentioned Royal Decree of 6 June 1960;
3* the patients participating in the trial present the same characteristics as those who are covered by the indication stated in the above-mentioned authorization.
Chapter XIX: SPECIAL PROVISIONS FOR NON-COMMERCIAL EXPERIMENTATION
Article 31
§1 The King may, after advice from the Advisory Committee for Bioethics, approve non-profit making organisations whose social objective is principally research and which have submitted an application, in order that all or part of the experiments they conduct may be recognised as non-commercial experimentation, in as far as they meet the conditions as intended in article 2, 15º, b and c.
§2 If the trial is a non-commercial trial and it concerns a medicine that is already licensed, the sponsor is not required to abide by article 12, §2, 2º.
Furthermore in this care the sponsor benefits from an exception being made to article 29, §3 if he can demonstrate, at any time, that this is a trial being performed with a licensed medicine and that this medicine would have been prescribed in any case by the doctor if the patient had not been included in the trial. Any sponsors availing themselves of this facility should communicate this to the INAMI/RIZIV.
§3 If the clinical trial is a non-commercial trial the King may, by a Decree approved by the Council of Ministers, exempt the experimentation totally or partially from the requirements stated in article 25.
§4 In the context of non-commercial clinical research. the hospital pharmacist may by special dispensation from the arrangements of the Royal Decree of 19 October 1978 regulating pharmacies and medicines stores in healthcare establishments, prepare the medicine himself in the pharmacy and supply it for another hospital pharmacist, on condition that an agreement exists between the different hospitals establishing their respective rights and obligations.
§5 If the experimentation is non-commercial, the sponsor is exempt from payment of the tax intended by article 30.