NIS Considerations
CHCUK NewsletterOctober 2011
In this Month's Issue
Spain: AEMPS Website Updated
Switzerland: Human Research Law
Switzerland: NIS Approval Requirements




In this addition of NIS Considerations we've focused primarily on the new Swiss Human Research Law that was approved by the Swiss Parliament on the 30 September 2011.  The Law won't be enforced/implemented until summer 2013 so this is just a 'heads-up'.

I've also taken some time to re-clarify the approval requirements for 'NIS' in Switzerland as this often seems to cause confusion.

Best wishes,

Stuart McCully
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
Spain: AEMPS Website Updated
AEMPS website has been updated which has had an impact on previously provided links
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The website of the Spanish Agency of Medicines and Medical Devices (AEMPS) has recently been updated.  This means that the NIS links for the Spain-related documents provided Part 1 of the 'NIS Considerations: Europe' report will no longer work.

The AEMPS information on 'Observational post-authorization studies with human medicines' can now be found at:

Switzerland: Human Research Law
The Federal Law on Research in Humans was approved on 30 Sept 2011
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Up until now Switzerland has had no national legislation, which comprehensively regulates research with human subjects. The ratification of the Agreement of the Council of Europe on Human Dignity and Biomedicine and the draft for an Article of the Federal Constitution (Art. 118a Federal Constitution), which gives the Federal Government full competence for introducing legislation in the area of research with human subjects, are important steps in the direction of standardisation (as per Section 3.2 of the SAMS Manual: Research with Human Subjects 2009).

On 30 September 2011 the Federal Law on Research Involving Human Subjects (Human Research Law) was adopted by Parliament. The purpose of the law is to protect the dignity, personality and health of people in the research.The law is expected to come in to force in summer 2013.

Purpose of the Human Research Law:
  • To create favourable conditions for research on humans
  • To help ensure the quality of research on humans
  • To ensure the transparency of research involving human subjects  

Key requirements defined by the Human Research Law is that any research involving humans:
  • Requires prior approval of a research ethics committee
  • Should be based on prior written informed consent (although certain exceptions are permitted)
  • Requires the sponsor to provide insurance should the participants suffer harm during the project (although exemption to this requirement may be granted)
  • The interests, health and welfare of individuals take precedence over the interests of science and society  
The Human Research Law defines the requirements for:
  • Remuneration - namely that study participants may not  receive a fee or other 'pecuniary advantage' when participating in direct benefit trials. Whereas, participation in a research project with no expected direct benefits (e.g., Phase 1 studies) can be adequately remunerated 
  • Defines when and how it is acceptable to use placebos in research projects 
  • Use and re-use of human biological material, health data and genetic data
  • Storage and export of human biological material, health data and genetic data
  • Research projects  in special circumstances:
    • Research involving materials and data from deceased people
    • Research involving legally incapacitated individuals
    • Research involving persons deprived of liberty
    • Research in emergency situations
    • Research projects with young people (minors) 

Further details can be found at: 



Switzerland: NIS Approval Requirements
What Approvals Do I Need Before I can Conduct a Non-interventional Study in Switzerland?

Phase IV Clinical Trials with Authorised Medicinal Products

The term "non-interventional study" does not exist in Swiss law. Clinical studies
have to be notified to Swissmedic if they correspond to the definition of a clinical trial given in Art. 5 of the Ordinance on clinical trials of therapeutic products (VKlin)

See Swissmedic website

"Article 5 a VKlin only defines the term 'clinical trial' (Art. 5 a VKlin), but not other projects such as non-interventional studies, post-authorization safety studies, application observations, and the like. If such projects are carried out using pharmaceuticals they are defined as clinical trials on pharmaceuticals (even if they are authorized preparations in an authorized application) and therefore come under the requirements of VKlin.

On the other hand, a clinical report need only be submitted to the cantonal ethics committee, and only when the cantonal regulations require this."

Prospective and Retrospective NIS

Furthermore, according to communication with a representative from the clinical trials unit of swissmedic on the 2nd and 3rd June 2009:

"Prospective and Retrospective NIS which fit within the definition of an NIS provided in Article 37 of the SGCI COP do not currently fall under the remit of VKlin and do not require approval of, or notification to, swissmedic. The only current requirements for the conduct of NIS are prior REC approval."

According to swissmedic, this is likely to change when the new Federal Law on Human Research (which was approved on 30th September 2011) is implemented in 2013.

Non-interventional Studies using Authorized Medicinal Products

In accordance with Article 37 of the SGCI Code of Practice, those studies which do not fall within the regulations of the Swiss legislation on Therapeutic Products for Clinical trials (e.g. reports on practical experience), and show the following characteristics, are considered non-interventional studies with authorized medicines:
  • An authorized medicinal product is prescribed, dispensed or applied by the health care professionals taking part in the investigations in the usual way, complying with the currently valid professional information.
  • The involvement of patients in such an investigation is not determined in advance by an investigation protocol and the prescription, dispensing or use of medicines is clearly separate from the decision to include a patient in the investigation.
  • No additional diagnosis or control measures are provided for patients; epidemiological methods are used for analyzing the collected data.

Prospective Disease Registries

If you intend, for example, to study the progression of a disease by observing disease progression (longitudinal observational study) and wish to follow patients during their routine practice with an additional blood sample taken for genetic analysis, then according to recent communication with Swissmedic (28 Oct 2011), this type of study does not fall within the scope of Article 5a of VKlin and therefore requires only Research Ethics Committee approval.

If in doubt about the regulatory classification of your study contact Swissmedic who are very efficient and will generally respond within 48 hours.