Clause 4 Responsibilities

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Clause 4
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4.1

(25.1) Companies must have a scientific service to compile and collate all information received from any source about the medicines which they market.

4.2

(25.2) Companies must have a scientific service to deal with the approval and supervision of non-interventional studies. This scientific service must include a registered medical practitioner or a pharmacist registered in the UK who will be responsible for the oversight of non-interventional studies (including the review of any responsibilities relating to such studies, particularly those given to representatives) and certification of the protocol.

4.3

(24.1) Companies must document and publicly disclose certain transfers of value made directly or indirectly to health professionals, other relevant decision makers and healthcare organisations located in Europe as set out in Clause 28. This includes any employee of a pharmaceutical company whose primary occupation is that of a practising health professional.

4.4

(27.7 and 27.8) Companies must document and publicly disclose annually donations and grants whether financial, non-financial or a benefit-in-kind, and sponsorship (including in relation to events/meetings) made to patient organisations.

Fees and expenses for the provision of contracted services, including those performed by individuals representing patient organisations, which should be paid to patient organisations must also be publicly disclosed annually as set out in Clause 29.

4.5

(New Clause) Companies must document and publicly disclose annually fees and expenses made to individual members of the public, including patients and journalists, for the provision of contracted services performed as set out in Clause 30.

4.6

(13.1) Companies must disclose details of clinical trials in accordance with the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature. Companies must include on the home page of their website information as to where details of their clinical trials can be found.

  • Clause 4.6 (13.1) Details of Clinical Trials

    This clause requires the provision of details about ongoing clinical trials (which must be registered within 21 days of initiation of patient enrolment) and the results of completed trials for medicines licensed for use and commercially available in at least one country.

    Further information can be found in the current Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases and the current Joint Position on the Publication of Clinical Trial Results in the Scientific Literature, both at www.ifpma.org/resource-centre/clinical-trials-position-papers/.

    Details about clinical trials must be limited to factual and non-promotional information. Such information must not constitute promotion to health professionals, other relevant decision makers or the public.

4.7

(13.3) 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.

4.8

(26.5) Companies are responsible for information about their products which is issued by their agencies eg communications, advertising etc.