Other Country Topics
Austria - other studies
Laws and regulations
If the clinical trial is conducted without the use of medical devices or medicinal products there is no specific legislation in Austria. According to § 8c KaKuG (see Gesamte Rechtsvorschrift für Krankenanstalten- und Kuranstaltengesetz (Austria)/KaKuG) only an opinion from the Ethics Committee is required for a new medical method.
The Ethics Committee responsible for the physician involved must give this opinion according to the:
- Ärztegesetz 1998 (Austria) (professional code of conduct for physicians)
In terms of the privacy of the participants, the following has to be regarded:
- Bundesdatenschutzgesetz (Austria) (see also the unofficial English translation Bundesdatenschutzgesetz - Data Protection Act (Austria), English version)
Furthermore, the clinical trial has to be conducted in accordance with the Declaration of Helsinki.
Germany - other studies
Laws and regulations
If the clinical trial is conducted without the use of medical devices or medicinal products there is no specific legislation in Germany. Only an opinion from the Ethics Committee is required.
The Ethics Committee responsible for the physician involved must give this opinion according to section 15 of the Professional Code for Physicians (Berufsordnung).
See: German Musterberufsordnung (professional code for physicians)
Due to the fact that Germany is a federal republic, the different state chambers of physicians (Landesärztekammern) have their own professional codes. These codes are based on the Musterberufsordnung of the German Medical Association (Bundesärztekammer) which serves as a model for the professional codes of the state chambers.
In some federal states (Bundesländer) for epidemeological studies an opinion is waived.
In terms of the privacy of the participants the German Data Protection Act has to be regarded:
- Bundesdatenschutzgesetz (BDSG) - German Data Protection Act (see also the unofficial translation published in the Federal Law Gazette: Bundesdatenschutzgesetz (BDSG) - English version)
Furthermore, the clinical trial has to be conducted in accordance with the Declaration of Helsinki.
Ireland - Other clinical research
Legislation
If the clinical trial is conducted without the use of medical devices or medicinal products there is no specific legislation in Ireland, only an opinion from the local Ethics Committee (where the research is being conducted) is required.
There does exist, however, more general pieces of legislation which the committee must comply with, for example:
- The Irish Data Protection legislation
- The Freedom of Information legislation
- The common law on consent for medical treatment and research
In addition, there are relevant publications from the Irish Council for Bioethics to consider (see: Irish Council for Bioethics - Guidance) and many professional organisations have guidelines, e.g., An Bord Altranais (Irish Nursing Board) and the Irish Medical Council.
The IMB has produced Guidelines for Pharmacogenetic Research in Ireland.
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| Irish Medicines Board | ||||
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Poland - Other studies
Non-commercial Clinical Studies
Non-commercial clinical studies are defined in The Act on Pharmaceutical Law of 6 September 2001, Dz.U. 2008, No 45, item 271 Art. 37ia. If an owner of data from a clinical study is an academic institution or another institution with rights to issue scientific titles, researcher, patients organization, researchers organizations or another organization which aim is not gaining profits from clinical studies or manufacturing or circulating medicinal products, the study is a non-commercial clinical study. Data from a non-commercial study cannot be used for an approval of a medicinal product, for changes in current approval, nor for marketing purposes. Sponsors applying for a non-commercial study, must submit a statement that there are and will be no agreements for an approval of a medicinal product, for changes in current approval, or for marketing purposes. If there are any medicinal products obtained from a manufacturer or any other item free of expense or with reduced purchases cost, or any other type of support from them, the IEC and the President of URPL. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) and URPL - English Information) have to be informed immediately.
Additional Links & Resources
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| The Ministry of Health (Poland) - Ministerstwo Zdrowia | ||||
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Portugal - Other studies
Biobanking
In Portugal biobanks are regulated by Law (No. 12/2005) which indicates that the harvest of biological samples is allowed only when there is ethics committee approval and the collection of clinical data is regulated by the National Commission for Data Protection.
Data Protection
Clinical studies have to be in line with the Portuguese Data Protection Law (Data Protection Act – Act 67/98 of 26 October). More information (e.g., concerning homeopathic products) can be found on the website of the Instituto Nacional de Farmácia e do Medicamento (INFARMED)..
Additional Links & Resources
- Comissão Nacional de Protecção de Dados - Portuguese Data Protection Authority (CNPD)
- PORTAL ENSAIOS CLÍNICOS - Clinical Trials Portal [English version]
Spain - Non interventional research
Legislation
Non interventional research is covered by:
Non-interventional studies with authorised medicinal products are regulated by:
Additional Links & Resources
- Ministerio de Sanidad y Consumo - Spanish Ministry of Health
- Agencia Española de Medicamentos y Productos Sanitarios/AEMPS - Spanish Medicines Agency
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| Agencia Española de Medicamentos y Productos Sanitarios/AEMPS - Spanish Medicines Agency | ||||
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