This edition  captures the recent changes in the requirements for non-interventional clinical trials (NCTs) in Slovakia and France.

Stuart McCully
CHCUK

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The following provisions apply to any research which is subject to financial compensation and which is performed and/or sponsored by the pharmaceutical industry, except for clinical trials as defined and regulated by Sections 29 - 44 of Act No. 362/2011 Coll. on Medicinal
Products and Medical Aids, as amended, regardless of whether it is performed by the manufacturer or by the organisation acting in compliance with or based on the manufacturer's instructions.

Research shall mean:

(a) A non-interventional clinical trial, as defined in Sec. 45 of Act No. 362/2011 Coll. on Medicinal Products and Medical Aids, as amended;

(b) Other studies and research, where data collection is not directly related to the prescription of certain medicinal products (e.g., epidemiological studies, marketing research).


8.1 Non-Interventional Clinical Trial (NCT)

8.1.1 The aim of NCT is to acquire scientific and professional information defined in NCT protocol.

The purpose of NCT shall be to obtain an answer to a scientific question which has not thus far been answered.

NCT must be performed while observing the provisions of Act 428/2002 Coll. on Personal Data Protection, as amended.

NCT must not constitute an incitement to recommend, prescribe, purchase, supply, sell or administer any specific medicinal product.

8.1.2 NCT is defined in Section 45 of Act No. 362/2011 Coll. on Medicinal Products and Medical Aids, as amended.

NCT can only be performed with the prior written approval of the NCT participant's health insurance company based on NCT protocol submitted by the professional coordinator.

8.1.3 Each NCT must have a formal protocol providing the following data:

(a) Name and surname or a company name of the NCT sponsor;

(b) Address or registered office of NCT sponsor;

(c) Title of the NCT;

(d) Objective of the NCT,

(e) NCT commencement and completion date;

(f) Name of the professional coordinator;

(g) NCT data processing method;

(h) Date, form and term of publication of NCT results; the term shall not be shorter than two months from completion of the NCT;

(i) Financial compensation for the NCT professional coordinator.

Each NCT must have its code indicated on every page of the protocol and on every page of the questionnaire so that the NCT is identifiable.

The protocol must be approved by the scientific service of the Member, which shall also supervise the performance of the NCT. Additionally, the protocol must be approved by health insurance companies of all NCT participants.

After the NCT protocol is approved by the NCT participant's health insurance company, the sponsor shall send it to the National Medical Information Centre, which will publish it on its website within three days from receipt.

The sponsor shall send a counterpart of processed NCT results to the NCT participant's health insurance company and to the National Medical Information Centre, which will publish it on its website within three days from receipt.

• number of centres,
• number of patients,
• number of physicians,
• evaluation form (e. g. questionnaire),
• statistical evaluation of the NCT.

8.1.4 The protocol must be given to each NCT investigator upon commencement of his/her cooperation in the NCT. Additionally, a written agreement shall be signed by each NCT investigator; the agreement shall set forth the terms of cooperation and compensation.



Results of NCT must be published within 12 months from the completion date of data collection.

8.1.8 Medical representatives are excluded from the following NCT phases:

• Formal preparation of the agreement (completion of necessary forms, etc.);
• Agreement on compensation for the cooperation;
• Payment of any compensation.

Medical representatives may in no case motivate solvers to recruit patients for the NCT.

 

Medical representatives' NCT-related visits to the study doctor's office must not be associated with any promotional activities.

 

 

• Before commencement of the NCT, medical representatives must be informed of how to report adverse effects and who the contact person is at the company's Slovak branch or at the headquarters.
• A medical representative may only hand over the contract, previously prepared by the sponsor, and if the contract is signed by the doctor, the medical representative shall return it to the sponsor.
• Medical representatives shall distribute protocols, questionnaires and agreements, and collect questionnaires unless the documents are sent by mail.

8.1.9 Every NCT must be notified to the office of the relevant Member's association before commencement of the NCT. Notification of NCT to the Member's home association shall include complete documentation.

If a complaint is filed, the Ethics Committee shall ask the office of the relevant Member's association for the complete trial documentation.

The mandatory notification must contain the following information:

• the title and objectives of the trial,
• identification of the organisation or the sponsor organising and/or performing the NCT,
• time schedule - expected data collection commencement and completion dates,
• number of patients/centres involved,
• planned date and form of publication of results,
• the complete trial protocol and documentation, including approval of the relevant Ethics Committee, in accordance with Section 2, par. 12 and Section 5 of Act No. 576/2004 Coll. on Health Care, as amended, and financial terms under which the trial is performed, including the draft financial agreement with the doctor.

The following documentation shall be published on the intranet of the relevant association and made available to all Members of the association:

• Subject matter of the protocol;
• Financial terms under which the trial is performed (this applies only to members of SAFS)

8.2 Other Studies
8.2.1 In addition to obtaining scientific and professional information, the objective of other studies carried out and/or sponsored by the pharmaceutical industry (hereinafter only "Other Studies"), may be obtaining information for the sponsor's needs.

• Marketing research to establish the position of a medicinal product in relation to other medicinal products in the group;
• Marketing research to establish the quality of work of the sponsor (medical
• representatives, marketing, etc.);
• Marketing research to establish doctors' therapeutic habits;
• Epidemiological research to establish the occurrence of a certain disease.

8.2.2 Proposal for cooperation in Other Studies must not be associated with the prescription of any medicinal product.

8.2.3 The compensation to a solver for cooperation in Other Studies shall be in line with the work performed, it has to be derived from a usual price, and it shall not exceed the amount equal to 1/10 of the minimum monthly wage* per hour.

8.2.4 Medical representatives are excluded from the following stages of Other Studies:

• Formal preparation of the agreement (completion of necessary forms, etc.);
• Agreement on compensation for the cooperation;
• Payment of any compensation.

• A medical representative may only hand over the contract, already prepared by the sponsor, and if the contract is signed by the doctor, the medical representative shall bring it back to the sponsor.
• Medical representatives shall distribute protocols, questionnaires and agreements, and collect questionnaires unless the documents are sent by mail.

8.2.5 Every other study must be notified to the office of the relevant Member's association before commencement of the study. If a complaint is filed, the Ethics Committee asks the office of the relevant Member's association for the complete trial documentation.

The mandatory notification must contain the following information:

• Title and objectives of the other study;
• Identification of the organisation or the sponsor organising and/or performing the study;
• Time schedule - expected data collection commencement and completion dates;
• Number of patients/centres involved; and
• Planned date and form of publication (if it is planned to publish the results), or
• Reasoning why the results were not intended for publishing.

8.3 Notification
Any trials or studies must be notified at SAFS, GENAS or ADL offices based on the membership in the association. The notifications shall only be made available to the authorised person of the office of the relevant association, and to the members of the Ethics Committee if a complaint is heard before the Committee

Useful Links:

• SAFS Code of Ethics of the Pharmaceutical Industry in Slovakia - February 2012  
• Act No. 362/2011 

The LEEM Code of Ethics ("Dispositions déontologiques professionnelles applicables aux entreprises du médicament") have been updated as of 31 March 2012.

The "Provisions applicable to professional ethical pharmaceutical companies" meet all applicable ethical commitments to the profession at September 6, 2011.

They integrate by merging codes, charters and provisions:

1) EFPIA Code on the promotion of prescription-only medicines from medical health professionals and relationships with these professionals approved by the Board of EFPIA October 5, 2007. 2) the IFPMA Code of good practice for the promotion of Medicines April 21, 2006;

2) the IFPMA Code of good practice for the promotion of Medicines April 21, 2006;

3) EFPIA Code of Practice on relations between the pharmaceutical industry and patient organizations adopted by the Board of EFPIA October 5, 2007;

4) Charter of the medical examination of 22 December 2004 as amended by amendments dated July 21, 2005 and July 21, 2008;

5) Charter for Internet communication pharmaceutical companies entered into between the Director and the President AFSSAPS LEEM October 30, 2006;

6) Code of Practice "Continuing Medical Education organized by a recognized organization in partnership with health companies" signed on 22 November 2006 between LEEM and the Minister of Health and Solidarity;

7) Commitments of good practice in relations between Pharmaceutical Companies and the press - in July 2007.

They include the attached excerpts of the statutes and rules of procedure relating to Codeem Leem.

According to Section 1.2.6 of the 2012 LEEM Code of Ethics:

1.2.6. Non-interventional studies on marketed drugs

A non-interventional study on a marketed drug is defined as a study in which the drug or drugs is (are) prescribed (s) under the usual conditions, in accordance with the terms of the authorization on the market. The decision to use a therapeutic strategy for a particular patient is not taken in advance as part of a trial protocol but intervenes in the course of practice and how the medicine is not related the decision to include the patient in the study. No additional diagnosis will be performed, no additional monitoring procedure will be introduced to the patient and epidemiological methods shall be used to analyze the data collected.

The non-interventional studies that are prospective in nature and which involve collecting data on patients with, or on behalf of, health professionals, acting individually or in groups, specifically for study purposes, must meet to all of the following conditions:

(A) the study should be conducted for scientific purposes;

(B) (i) there is a written plan of study and / or protocol and (ii) there are written contracts between, on one hand, health professionals and / or institutions where the study will be conducted and, secondly, the corporate sponsor of the study, which specify the nature of the services to be provided and, subject to subsection (c) below, the basis of remuneration for such services;

(C) if compensation is provided, it must be reasonable and reflect the fair market value of the work;

(D) in countries where ethics committees have jurisdiction to review such studies, the study protocol must be submitted to them;

(E) laws and regulations regarding the protection of personal data must be respected;

(F) the study should not be an incentive to advise, prescribe, purchase, supply, sell or administer medication;

(G) the study protocol must be approved by the scientific department of the company and the conduct of the study must be supervised by the science department in accordance with paragraph 2.1.1a;

(H) the results of the study must be analyzed by or on behalf of the contracting company and summaries must be provided to the scientific service of the company (as described in paragraph 2.1.1 a) within reasonable scientific service to keep these reports in its archives for a reasonable period. The company must send the summary report to all health professionals who participated in the study and provide, upon request, to self-regulatory organizations of industry and / or committees responsible for
supervisory or enforcement of these provisions. If the results of the study are important for purposes of evaluating the risks and benefits, the report summary should be sent immediately to the relevant competent authority, and

(I) medical representatives can not be involved in the establishment (pre-recruitment and recruitment and financial relationships with physicians) studies. They can monitor. Medical sales representatives can be involved in administrative functions and this involvement must be supervised by the scientific department of the company will also ensure that visitors are properly trained. This participation should not be linked to the promotion of a drug. The establishment (recruitment and financial relationships with physicians) of pharmacoeconomic analyzes and clinical trials, including Phase IV, and observational studies, not within the missions of the medical representative. However, it can monitor.

Businesses are asked to comply with the provisions of paragraph 2 of subsection 1.2.6 to the extent they are applicable to all types of studies in the first paragraph of this subsection 1.2.6, including epidemiological studies and other retrospective studies in nature. In all cases, these studies are subject to the provisions of the first paragraph of this subsection b.

Useful Links:

• LEEM: Provisions applicable to professional ethical pharmaceutical companies (31 March 2012)   

IMPORTANT

 

Please note that:   

• AFSSAPS is now the Agence nationale de sécurité du médicament et des produits de santé (ANSM)
• NIS now require research ethics committee (CPP) approval