This is a busy edition in which we've captured many of the recent NIS-related changes in Europe so that you have some 'gentle' reading as you go off on your summer breaks.

Stuart McCully
CHCUK

According to the 'General Authorisation to Process Personal Data for Scientific Research Purposes  of 1 March 2012' published by the Italian Data Protection Authority:

The processing of personal data suitable for disclosing data subjects' health, without their informed consent, for scientific research purposes in the medical, bio-medical or epidemiological sectors is possible subject to compliance with the following imitations:

This Authorisation shall be granted if:

• the processing of data that are suitable for disclosing health for scientific research purposes in the medical, bio-medical or epidemiological sectors is necessary to conduct  studies that do not entail any significant personalized impact on data subjects and rely on data that was collected beforehand for health care purposes and/or to implement prior research projects and/or on data that was extracted from biological samples removed beforehand for health care purposes and/or to implement prior research projects; and

 

• the research is performed on the basis of a project that received a reasoned favourable opinion from the geographically competent ethics committee in accordance with the terms set forth in Article 3 of the Code of ethics and professional practice applying to the processing of personal data for statistical and scientific purposes (Annex A.4 to the Data Protection Code).

The studies covered by this Authorisation may also concern the relationships between risk factors and human health, be aimed at assessing safety and effectiveness of drugs and medical devices in clinical practice and/or checking their appropriate prescription, or deal with health care events related to diagnosis, treatment or prevention or else with the use of welfare and health care facilities (as per Section 2 of the General Authorisation to Process Personal Data for Scientific Research Purposes - 1 March 2012).

For further information, refer to the Website of:

• The Italian Data Protection Authority 

The FARMAINDUSTRIA Code of Professional Conduct has been updated as of 22 February 2012.  The changes have no significant impact on the guidelines for the conduct of non-interventional studies in Italy.

It is worth noting that, in accordacnce with Section 1.13 of the :

By February 28th of each year member companies shall acquire and submit to the President of Farmindustria a certificate attesting to the observance of procedures governing marketing and scientific information activities in the preceding year. The attestation must be issued by entities recognised by SINCERT (the national system for the accreditation of Certification Bodies)

The 2012 SFEE Code of Practice implements significant changes with respect to the conduct of non-interventional studies in Greece so please do read the code in detail!

The following, provides a brief overview of the changes.

When is the 2012 in Force?
From 2nd April 2012

So Whats New?
The 2010 SFEE Code of Practice caused some challenges confusion by grouping Clinical Trials with Epidemiological Trials, whilst separately addressing Non interventional trials.

The 2012 SFEE Code of Practice has addressed this by the guidance on Non-Interventional Trials with Pharmacoepidemiological Trials and dealing with Interventional Clinical Trials separately


Competent Authority Approval (EOF)
The only type of non-interventional/pharmacoepidemiological trials which
are from now on submitted to EOF are the non-interventional post marketing
studies of safety or efficacy which are required by the competent authority either at the granting of the marketing authorization or later and which are subject to EOF's prior approval (as per Section 29.3 of the 2012 SFFE COP)

Refer to: CIRCULAR 17079/4-3-2011  - Clarification Instructions on non-interventional studies


Market Research
The following section has been added to requirements for Market Research (Article 27):

• The data collected by the healthcare professionals concerning patients must be cumulative. In a market research no personal data of the patients must be collected because in such a case it is considered as a non interventional/pharmacoepidemiological trial and it is covered by the provisions of article 29.

 
Further Diagnostic Procedures
The 2010 SFEE Code of Practice stated:

• No further diagnostic or follow-up procedure shall be imposed on the patients, nor will epidemiological methods be used for the analysis of collected data.

The 2012 SFEE Code of Practice now states:

• No further diagnostic or follow-up procedure shall be imposed on the patients, and epidemiological methods will be used for the analysis of data collected according to the principles of Vol 9A.

Increased Scope

• 2010 SFEE Code of Practice: Prospective Non-interventional trials
• 2012 SFEE Code of Practice: Non-interventional/ pharmacoepidemiological clinical trials for medicinal products, of prospective or retrospective nature

Study Approval and Registration
The trial protocol must be submitted for evaluation to the competent
committees (scientific or deontology committees) and uploaded to an online
registry of clinical trials, which has free access to the public (as per Section 29.2.d of the 2012 SFFE COP)

Before the beginning of the trial, the basic characteristics of the trial must
be recorded in a special registry with free access to the public (as per Section 29.2.h of the 2012 SFFE COP)

The pharmaceutical company must send the brief report to all healthcare professionals participating in the trial and must record it to a special registry of noninterventional/ pharmacoepidemiological trials (as per Section 29.2.i of the 2012 SFFE COP)


Involvement of Medical Sales Representatives
Medical sales representatives are not allowed to be involved in the conduct
of the trial (as per Section 29.2.j of the 2012 SFFE COP)


Provision for the Organization of Scientific Events
This section has been significantly updated and the types of event split into types A, B or C.  Each of which has differing approval requirements.  Note that all scientific events will need prior approval from the National Competent Authority (EOF).

Refer to Sections 21 to 23 of the 2012 SFEE COP for further details

The requirements for the conduct of NIS remain unchanged from the 2008 Code of Deontology (see below).

According to Article 44 of the Pharma.be Code of Deontology 2012: 

In carrying out the scientific studies referred to under article 43, companies shall ensure, notwithstanding the legal and regulatory provisions on this subject, that the following conditions are respected, to the extent that they are relevant to the case in question:

 

• the study is conducted with a clear scientific purpose;
• a written scientific protocol shall provide a detailed description of the purpose sought and methodology implemented; the aforementioned purpose and methodology shall always be coherent with one another;
• the scientific protocol must be approved in advance by the company's scientific service as referred to under article 6 of this Code and this service has to supervise the conduct of the study;
• a written contract shall provide a detailed description of the services expected from the investigators as well as of the amount and the procedures for remunerating the investigators;
• the remuneration is commensurate with the services requested and reflects the market value thereof;
• the procedures for supplying the medicines studied shall be described in detail in the protocol; they shall be coherent in regard to the stated purpose and methodology;
• the future use of the data collected shall be stated clearly in the protocol;
• the study results must be analysed and reports thereof must be submitted within a reasonable period of time to the company's scientific service which shall maintain these reports for a reasonable period of time;
• the company must send the study results to all healthcare professionals who participated in the study; the study results should also be kept at the disposal of the bodies of pharma.be as referred to under article 52, paragraph 1 of this Code and must be submitted following a request on their part; if the study shows results that are important for the assessment of the benefit-risk ratio of the studied medicinal product(s), these results should be immediately forwarded to the competent authority;
• the number of patients requested for inclusion as well as the number of investigators included shall be justified in a scientific manner in the protocol, for example by means of a biostatistical calculation;
• the study must not constitute an inducement to recommend, prescribe, purchase or sell, supply or administer medicinal products;
• medical informants may only intervene in a study to perform administrative tasks under the supervision of the company's scientific service; this service will ensure that the medical informants are adequately trained for this purpose; their involvement in scientific studies must not be linked to the promotion of medicinal products. 

The Danish National Board of Health and the Danish Medicines Agency have merged, forming a new and larger organisation with around 700 employees, under the continuing name Danish Health and Medicines Authority.

The merger was completed on 1 March 2012 with the insertion of the Danish Health and Medicines Authority's new executive management and the launch of a new organisational structure.

Refer to: Danish Health and Medicines Authority (DKMA)

From 15 May 2012, the following processing of sensitive personal information is no longer declared and obtain permission from the DPA:

• Clinical trials on medicinal products subject to the law on drugs
• Clinical trials of medical devices covered by the Act on Medical Devices 
• Duty-related safety monitoring of drugs and medical devices under the Pharmaceuticals Act or the Act on medical devices.

(Source: http://www.datatilsynet.dk/erhverv/forskere-og-medicinalfirmaer/medicinal-og-medicoindustrien-mv/)

Continuing notification requirement for certain treatments

The exemption from the notification requirement applies  not  to the processing of personal data in connection with  non-intervention trial .The exception does not apply  to biological material for future  use, ie.biological material not included in the individual clinical trials, but stored for future research.

Non-interventional studies, and biological materials which are not included in the clinical trial must therefore continue to be notified to the Data Protection Agency (as per the Datatilsynet Guidance on the Pharmaceutical and Medical Device Industry, etc...).

Non-intervention trials must be reported on the form  Private research  (as per the Datatilsynet Guidance on the Pharmaceutical and Medical Device Industry, etc...).

Biological material for future research must be reported on the form  Private company where the biological material is expected to be included in trials of drugs or tests of medical devices (as per the Datatilsynet Guidance on the Pharmaceutical and Medical Device Industry, etc...).

If the material is only likely to be used for research that does not require consent under the statutory § 10 (see on § 10 below), the notification should be made on the form  Private research  (as per the Datatilsynet Guidance on the Pharmaceutical and Medical Device Industry, etc...).