NIS Considerations
CHCUK Newsletter February 2010
In this Month's Issue
NIS Reports: Clarification
Turkey: Obs Study Guidance
Spain: Draft Guidelines Finalised
Sweden: LIF COP Updated
Switzerland: Unifying Human Research Law




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Welcome to February 2010 edition of 'NIS Considerations'. 

This month we focus on the country-specific NIS guidelines which have been published or updated by various responsible bodies.

I've also responded to a number of queries regarding the NIS Reports on whether and when they will be updated.

Please feel free to contact me at any time if you have any comments or queries about the NIS Reports and our services.

Best wishes,
Stuart McCully
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
NIS Reports: Clarification
Clarification on the intent to update the NIS Reports

We have recently had a few queries about the NIS Reports and how/if we intend to update them.  So for clarification:

Is Part 2 of the NIS Report, the 2nd Edition of Part 1?
No.  These are two seperate reports which cover the NIS regulations and guidelines of different European countries (see below).

Countries covered by Part 1 of the Report: Belgium, France, Germany, Greece, Poland, Portugal, Spain, Sweden, Switzerland, The Czech Republic, The Netherlands

Countries covered by Part 2 of the Report: Austria, Bulgaria, Cyprus, Denmark, Estonia, Finland, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Romania, Slovakia, Slovenia, and the UK

Will You Be Updating the Reports?  If so, How Often?
Yes.  The intention is to update the reports on an annual basis.

How Much will the Updated Reports Cost Me?  Is there a Discount for Customers Who Have Previously Bought the Report(s)?
The Updates Cost Nothing. If you have previously bought the report(s), you will receive the updated report free of charge.

Turkey: Obs Study Guidance
Guidance on Observational Studies Performed with Drugs

The General Directorate of Pharmaceuticals and Pharmacy (IEGM) has published guidance on the minimum requirements for planning, conducting and evaluating observational studies performed with drugs.

The Clinical Research Association of Turkey has also, just as helpfully, compiled some guidance on how to perform observational studies in Turkey.

Please note - to access the website of the Clinical Research Association you will first need to register.  The process is painless and free and well worth the very minimal effort required.
Spain: Draft Guidelines Finalised
AEMPS Guidelines for Post-authorisation Observational Studies for Human Medicines
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The draft 'Guidelines on Post-Authorisation Studies of Drugs for Human Use' published by the 'Coordinating Committee for Post-Authorisation Studies' on the 1st June 2009 were finalised on the 16th December 2009 and published through the following Ministerial Order:

Note - These guidelines are in Spanish

Sweden: LIF COP Updated
The LIF Code of Practice was Updated in July 2009
LIF Logo
Please note that the LIF "Ethical Rules for the Pharmaceutical Industry in Sweden" were updated in May 2009 and became effective in July 2009 and are now more comprehensive than the May 2008 version.  The link provided below takes you to the latest version of the 'Code of Practice' with revisions highlighted in yellow.

All the applicable regulations are now gathered in a single code which cover:
  • Ethical rules for the pharmaceutical industry
  • Agreements on forms of collaboration with health care etc.
  • Ethical rules as to co-operation between companies and user organisations/interest groups
  • Rules for non-interventional studies (Refer to Chapter IV)
  • Statutes of the Swedish Pharmaceutical Industry Information Examiner (IGM) and the Information Practices Committee (NBL)
  • Rules for procedure for the IGM and NBL
  • Regarding corruption and bribes
  • Ethical rules for interaction between pharmaceutical companies and veterinary care personnel
The hyperlink provided in Part 1 of the NIS Report now takes you to this updated version of the Swedish Code of Practice.
Switzerland: Unifying Human Research Law
Federal Act on Research Involving Human Subjects
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Some aspects of research on humans are not regulated at all in Switzerland or the regulations vary from canton to canton. That needs to change.  Dating back to the motion Plattner 98.3543, the Federal Council on 21 October 2009, the Embassy and the draft federal law on research involving human subjects (Human Research Act) was adopted and forwarded to Parliament for deliberation.

The constitutional basis for the Human Research Law in Switzerland is the constitutional article on research on human beings (Article 118b BV), which was adopted in September 2009 by parliament and will come out in March 2010 in a federal referendum.

Only time will tell what, if any, impact this will have on the conduct and managment of Non-Interventional Studies in Switzerland.