NIS Considerations
CHCUK NewsletterAugust 2011
In this Month's Issue
Europe: EFPIA COP Updated
UK: 2011 ABPI Code of Practice
Norway: LMI Marketing Rules - 2011 Amendmentland 2011
Norway: Translation of NIS Guidelines
Slovenia: A Re-cap of the Requirements
NIS Report (Part 2): 2nd Edition

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Greetings!

Welcome to the August edition of our NIS Considerations newsletter.  In this edition we're pleased to announce that the 2nd edition of Part 2 of the Report covering NIS Considerations in Europe has been prepared.

Best wishes,
What-Where-When

Stuart McCully
CHCUK
 
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
email: stuart.mccully@chcuk.co.uk
Europe: EFPIA COP Updated 
Amended Code Effective from1 Jan 2012
EFPIA

 

 EFPIA's General Assembly has approved the amended Code of Practice on the promotion of prescription-only medicines to, and interactions with, healthcare professionals (June 2011)

The amended code will be effective from 1 January 2012.

EFPIA and its members are conscious of the importance of providing accurate, fair and objective information about medicinal products so that rational decisions can be made as to their use. The EFPIA Code reflects the requirements of Council Directive 2001/83/EC, as amended, relating to medicinal products for human use. The EFPIA Code fits into the general framework established by the Directive, which recognises the role of voluntary control of advertising of medicinal products by self-regulatory bodies and recourse to such bodies when complaints arise.

Refer to the following links for further information: Article 15 (Non-interventional studies of Marketed Products) remains unchanged.

UK: 2011 ABPI Code of Practice
A 2011 Edition of the ABPI COP is Available 
ABPI_COP_2011
This edition of the Code of Practice comes into operation on 1 January 2011

 New considerations for NIS include the following:

 

Publishing of Results (Clause 13.2) 

  • Companies must publish the summary details and results of non-interventional studies of marketed medicines in a manner consistent with their parallel obligations with respect to clinical trials (as per Clause 13.2)
  • Note; This requirement applies to non-interventional studies

    completed on and after 1 May 2011 with which a UK company has had any involvement. Companies are, however, encouraged to publish details and results of such studies completed prior to that date. 

Use of Consultants (Clauses 20.2, 20.3 & 20.4)
  • 20.2 Pharmaceutical companies must make publicly available details of the fees paid to consultants in the UK, or to their employers on their behalf, for certain services rendered by them such as chairing and speaking at meetings, assistance with training and participation in advisory boards etc. It does not include payments to consultants in relation to research and development work, including the conduct of clinical trials. Nor does it include payment of UK travel costs or the cost of subsistence in relation to fees for services which are dealt with in Clause 20.3.
  • 20.3 In addition to the information required to be made public by Clause 20.2, companies must make publicly available details of payments made to consultants in relation to market research (unless the company concerned is not aware of the identities of those participating in the market research) and payments in respect of accommodation (both in and outside the UK) and travel outside the UK in relation to fees for services as defined in Clause 20.2.
  • 20.4 Fees, expenses and the like due to consultants in relation to Clauses 20.2 and 20.3 must be declared whether paid directly to them or to their employers or to companies or charities etc.

 

 

 

Norway: LMI Marketing Rules - 2011 Amendment
LMI's Rules for Marketing of Medicinal Products have been Updated   
Norwegian Flag

  

The rules are based on the Code of Practice adopted by the European Confederation of Pharmaceutical Manufacturers (EFPIA), which is the representative body for the European pharmaceutical industry to which LMI is affiliated. The latest version of EFPIA's Code of Practice on the Promotion of Medicines was adopted by EFPIA on 5 October 2007 with entry into force at national level no later than 1 July 2008. The code has been revised to make it fully consistent with Directive 2001/83/EC and Directive 2004/27/EC. Besides the Rules for Marketing of Medicinal Products, LMI's rules consist of agreements between LMI and the Norwegian Medical Association (NMA), the regional health enterprises, the Norwegian Nurses' Organisation (NSF), the Norwegian Association of Pharmacists (NFF) and the Norwegian Federation of Organisations of Disabled People (FFO), as well as guidelines adopted by LMI's Board. Reference is also made to public law rules and regulations.

 

As laid down on 15 November 1994 by the General Meeting of the Association of the Pharmaceutical Industry in Norway (LMI) including later amendments at the General Meeting of the LMI on 31 March 2009 and most recently at the General Meeting of 14 March 2011.

 

For further information refer to: 

 
Norway: Translation of NIS Guidelines
Unofficial English Translation of the LMI Guidelines for Non-Interventional Studies
Norwegian Flag
An unofficial English translations of the LMI's 2008 Guidelines for Non-interventional Studies is now avalaible for information purposes.  Refer to the link below:


 

Slovenia: A Re-cap of the Requirements
Notification and Approval Requirements for NIS in Slovenia
Slovenia Flag
Competent Authority Notification

In accordance with Article 19(3) of the Rules on Clinical Trials on Medicinal Products, 2006), approval or notification of a clinical trial of a medicinal product is not mandatory for non-interventional clinical trials. However, Article 29(1) of the Rules on Clinical Trials on Medicinal Products, 2006, requires that prior to the commencement of a non-interventional clinical trial, the applicant shall notify the authority responsible for medicinal products (JAZMP) thereof.

Prior to the commencement of a non-interventional clinical trial, the applicant shall notify the authority responsible for medicinal products thereof. The notification shall include:

  • The title of the clinical trial;
  • Data on investigational medicinal product (name, pharmaceutical form, strength);
  • Data on the researcher conducting the trial;
  • Data on the principal investigator;
  • The objective of the clinical trial on the medicinal product;
  • A statement and explanation that the clinical trial meets the requirements for a non- interventional clinical trial;
  • Data on the person responsible for pharmacovigilance and appointed by the marketing authorisation holder, who will perform his/her functions in accordance with the regulation on pharmacovigilance of medicinal products for human use.

Within 30 days of completion of the trial referred to in the first paragraph of this article, the applicant shall notify the authority responsible for medicinal products of trial completion (as per Article 29(3) of the Rules on Clinical Trials on Medicinal Products, 2006 ).

 

 

Ethics Committee Favourable Opinion

Ethical review is required for all research involving intervention on, or interaction with human beings. Additionally, it is required for all research on personal medical data, and biological material of human origin are also covered (Dr. Joze Trontelj, The National Medical Ethics Committee of Slovenia).

  

NMEC generally will not approve NIS studies in which there is no valid
scientific questions (e.g., appropriate methodology and trained responsible
researcher) and in which there is not a favourable relationship between the cost and benefits to the patient (
NMEC Position Paper: On ethical reviewing of phase IV clinical studies).

 

 

Institutional Approval

 

Statement by the Head of the institution or department where the study is to be conducted that he / she agrees to the study being conducted within the premises / under responsibility of the institution, that the responsible researchers are capable of recognizing dangerous adverse events and of taking appropriate care of any clinical contingency. A statement that they will adhere to the principles of the Helsinki Declaration, the Oviedo Convention on Human Rights and Biomedicine and the Slovene Code of Medical Deontology (refer to paragraph 12 of the NMEC checklist). 

 
 

  

Data Protection Notification

 

According to Article 27 of the Personal Data Protection Act 2004 (as amended):

 

(1) Data controller shall supply data from subparagraphs 1, 2, 4, 5, 6, 9, 10, 11, 12 and 13 of the first paragraph of Article 26 of this Act to the National Supervisory Body for Personal Data Protection (Information Commissioner) at least 15 days prior to the establishing of a filing system or prior to the entry of a new type of personal data.

 

(2) Data controller shall supply to the National Supervisory Body for Personal Data Protection modifications to the data from the previous paragraph no later than eight days from the date of modification.

  
NIS Report (Part 2): 2nd Edition
The 2nd Edition of Part 2 of the NIS Considerations Reports for Europe is Now Available
NIS Report-Part 2 (2nd Edition)
The second Edition of Part 2 of the NIS Reports has been prepared and will be released by 1st Sept 2011

The report is now more comprehensive and includes:

  • Data Protection: Information on the country-specific Data Protection Agencies and data protection requirements
  • Service Providers: Information about, and links to, companies and organisatopns who specialise in the conduct and management of NIS  
  • Country-Specific Information: The country-specific information has been updated to reflect the changes over the past 2 years.  In particular, the information for Austria has been extensively updated.  
The report will be emailed, free of charge, to all who have previoulsy purchased a copy. If you haven't received your copy, please contact me at stuart.mccully@chcuk.co.uk as soon as possible if you haven't received your copy by 1st Sept 2011 so that I can forward you a copy of the updated report.

 

CHCUK