Clause 3 Obligations

The legitimate exchange of medical and scientific information during the development of a medicine is not prohibited, provided that any such information or activity does not constitute promotion which is prohibited under this or any other clause.

NHS organisations and others involved in the purchase of medicines need to estimate their likely budgets in advance, so there is a need for them to receive advance information about the introduction of new medicines or changes to existing medicines which may significantly affect their level of expenditure, including that which might arise from changes in the patient pathway and/or service delivery.

When this information is required, the medicines concerned (or the changes to them) will not be the subject of marketing authorisations (although applications will often have been made) and it would be in breach of the Code for them to be promoted. Companies wishing to provide advance notification must ensure that information is also provided wherever possible for inclusion in national horizon scanning databases. Non-promotional information can be provided as advance notification, but it must:

i. relate to a product which:

• • contains a new active substance, or
  •  contains an active substance prepared in a new way, such as by the use of biotechnology, or
  • is to have a significant addition to the existing range of authorised indications, or
  • is to have a novel and innovative means of administration

ii. only be directed to those responsible for making policy decisions on budgets and not those only expected to prescribe

iii. state whether or not a new medicine or a change to an existing medicine is the subject of a UK marketing authorisation

iv. state the likely cost or savings and budgetary implications which must be such that they will significantly change the organisation’s likely expenditure (the budgetary implication might include the need for service redesign)

v. be factual and limited to that sufficient to provide an adequate but succinct account of the product’s properties; other products should only be mentioned to put the new product or indication into context in the therapeutic area concerned.

The information provided must not:

vi. be promotional in style – product logos should be avoided but company logos may be used; the brand name of the product may be included in moderation but it should not be stylised or used to excess

vii. include mock up drafts of either summaries of product characteristics or package leaflets.

If requested, further information may be supplied or a presentation made.

In response to certain types of public health emergency, under UK law, the licensing authority may temporarily authorise the sale or supply of a medicine without a marketing authorisation. This might apply to medicines without UK marketing authorisations or indications without UK marketing authorisations. The campaign must be approved by the health ministers and all other relevant requirements of the Code will apply. In relation to advertising to health professionals and other relevant decision makers, further information is given in Clause 11.3 and its supplementary information. In relation to advertising to the public, further information is given in Clause 26.1 and its supplementary information. Companies should contact the Medicines and Healthcare products Regulatory Agency (MHRA) for information regarding approval of materials and activities.

In response to certain types of public health emergency, under UK law, the licensing authority may temporarily authorise the sale or supply of a medicine without a marketing authorisation. This might apply to medicines without UK marketing authorisations or indications without UK marketing authorisations. The campaign must be approved by the health ministers and all other relevant requirements of the Code will apply. In relation to advertising to health professionals and other relevant decision makers, further information is given in Clause 11.3 and its supplementary information. In relation to advertising to the public, further information is given in Clause 26.1 and its supplementary information. Companies should contact the Medicines and Healthcare products Regulatory Agency (MHRA) for information regarding approval of materials and activities.

The advertising of prescription only medicines to the public is also prohibited by the relevant regulations relating to advertising.

The promotion of over-the-counter (OTC) medicines to the public for self-medication purposes is covered by the Consumer Code of the Proprietary Association of Great Britain (PAGB).

Compliance with all applicable codes, laws and regulations to which a pharmaceutical company is subject is particularly relevant when activities/materials involve more than one country or when a company based in one country is involved in activities in another country.

Activities carried out and materials used by a pharmaceutical company located in a European country must comply with the national code of that European country as well as the national code of the country in which the activities take place or the materials are used.

Activities carried out and materials used in a European country by a pharmaceutical company located in a country other than a European country must comply with the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code as well as the national code of the country in which the activities are carried out and materials are used. For example, a company located in the UK carrying out an activity outside the UK but within Europe, such as in France, must comply with the UK Code and the French Code regardless of whether or not UK health professionals or other relevant decision makers are involved. Conversely, a company located in France carrying out an activity in the UK must comply with the ABPI Code regardless of whether or not UK health professionals or other relevant decision makers are involved. Details of the various codes can be found at www.efpia.eu or www.ifpma.org.

The term ‘company’ means any legal entity that organises or sponsors promotion which takes place within Europe, whether such entity be a parent company (eg the headquarters, principal office, or controlling company of a commercial enterprise), subsidiary company or any other form of enterprise or organisation.

In the event of a conflict of requirements, the more restrictive requirements would apply. There is a potential exception with regard to the limits for subsistence set in European countries where the national association is a member of EFPIA and thus covered by the EFPIA Code as referred to in the supplementary information to Clause 10.7.

All international events, that is to say events that take place outside the responsible pharmaceutical company’s home country, must be notified in advance to any relevant local subsidiary or local advice taken.

Companies must take reasonable steps to ensure that any other parties that they commission to design, implement or engage in activities covered by the Code but which do not act on behalf of the company, and are therefore not covered by Clause 1.17, for example, joint ventures or licensees, comply with the Code.

There is an assumption that the responsible person is the managing director or chief executive or equivalent unless other formal arrangements have been made within the company.