Pharmaceutical Industry Regulation

All UK pharma companies are governed by one of these two options:

  • Self-regulation
  • Government regulation

Government regulation

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health and enforces the Human Medicines Regulations (2012).

The Blue Guide is a summary of the advertising regulations. Failing to comply with the regulations can result in the MHRA imposing criminal sanctions (eg, fines and/or imprisonment).

Pharmaceutical Industry Regulation

Self-regulation

Conversely, the UK also operates a system of self-regulation through the industry’s own representative body, the ABPI (Association of the British Pharmaceutical Industry).

"Our core values are communication, empowerment, collaboration, honesty and integrity and innovation. We reflect these in the way we work with each of our stakeholders and members."
- The ABPI

The ABPI code of practice sets out how the industry self-regulates, and operates according to civil law, ie, establishing whether a breach occurred or not on the “balance of probabilities”.

Prescription Medicines Code of Practice Authority

The code is enforced by the PMCPA (Prescription Medicines Code of Practice Authority) who operate at arm’s length to the ABPI.

The code encompasses requirements stipulated in IFPMA and EFPIA codes, as well as reflecting and extending beyond the relevant UK law.

ABPI members must abide by the code in spirit and letter.

Prescription Medicines Code of Practice Authority

Non-members may voluntarily agree to abide by the code and accept the jurisdiction of the PMCPA.

Why? Because:

  • The code sets a framework of rules, that also serves to create a level playing field across the industry.
  • The code reflects and extends beyond UK law.
  • The only other option is to be governed by the MHRA according to the advertising regulations.
  • Ultimately, the code serves to protect patients – in spirit and letter.

What Does the Code Cover?

Content of the 2016 version:

  • 29 clauses
  • Constitution and procedure
  • Guidelines on company procedures

Clauses are backed up by supplementary information.

Company SOPs may provide detailed interpretation and strict processes.

What Does the Code Cover?

  • Promotional and non-promotional materials and activities.
  • Promotion of medicines to health professionals and other relevant decision makers.
  • Communications to patients and the public, including relationships with patient groups.
  • Examples of areas covered:

    • Disclosure of transfer of values
    • Meetings
    • Representatives
    • Promotional aids
    • Patient support items
    • Joint working
    • Non-interventional studies
    • Use of consultants

Examples of Code Breaches

Clause 2:
Ruled if company has brought discredit to, and reduction of confidence in, the pharma industry.

Breaches of clause 2 are advertised in the BMJ, Pharmaceutical Journal and the Nursing Standard.

Clause 9.1:
Ruled if company has not maintained high standards.

Clause 15.2:
Ruled if sales representatives do not maintain a high standard of ethical conduct in the discharge of their duties.

 

Examples of Code Breaches

Clause 2 can be alleged in cases relating to:

  • Patient safety issues
  • Promoting to the public
  • Pre-licence/off-label promotion
  • Excessive/inappropriate hospitality
  • Unacceptable payments
  • Inducements to prescribe
  • Poor standards
  • Failing to comply with previous undertakings
  • Cumulative breaches
  • Conduct of company employees/agents

Appeal Board: Possible Actions

  • Rulings can be overturned.
  • Company audit of policies and procedures.
  • Pre-vetting of materials.
  • Need to recover items from HCPs.
  • Recall of materials.
  • Issue of a corrective statement.
  • Public reprimand.
  • Report a company to the ABPI board of management.

ABPI Board of Management: Examples of Sanctions

  • Board may then decide to suspend or expel the company from the ABPI.
  • If a company is not an ABPI member, the board may:

- Remove the company from the list of non-member companies which have agreed to comply with the code; and

- Advise the MHRA that responsibility for that company under the code can no longer be accepted.

Outside of the Code

The code does not apply to:

  • Non-medicinal products (eg, supplements, devices, etc).
  • The conduct of clinical trials.
  • Regulatory submissions and assessments.
  • Regulatory documents such as the SPC (summary of product characteristics).
  • Information supplied to national public organisations, such NICE (National Institute for Health and Care Excellence), AWMSG (All Wales Medicines Strategy Group) and the SMC (Scottish Medicines Consortium).

Note: this list is not exhaustive.

Promotion and Non-promotion

The code applies to:

  • Promotion of medicines to health professionals and other relevant decision makers.
  • Non-promotion to health professionals, other relevant decision makers, patients and the public.

What is promotion?

Any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines.

Promotion and Non-promotion

What can fall under the category of promotion?

  • Tone
  • Intent/impression
  • Content
  • Use

Context is everything.

Promotion and Non-promotion

Context is everything.

It depends on:

  • What the activity/material is
  • Who it is for
  • For what purpose
  • Who will use it
  • How it will be used

Ask these key questions:

  • Intention/impression?
  • Target audience?
  • Method of dissemination?

Promotion and Non-promotion

Examples of non-promotional areas include:

  • Medical education
  • Requests for information
  • Medical and educational goods and services
  • Legitimate exchange of medical and scientific information
  • Patients organisations
  • Grants and donations
  • Joint working
  • Public relations
  • Corporate advertising
  • Disease awareness campaigns
  • Advanced budgetary notification
  • Price lists
  • Patient literature
  • MSL activities
  • Clinical research
  • Factual announcements
  • Advisory boards
  • Package deals
  • Market research
  • Patient support programme
  • Terms of trade discussions
  • Risk sharing agreements

Each has a set of criteria to ensure activities remain compliant.

Example of a Case Ruling

At Teva’s lunchtime meeting (December 2017) with HCPs (healthcare professionals) from a private hospital, a Pharmasure representative dropped off a substantial Christmas chocolate hamper for the HCPs.

PMCPA website - Case AUTH/3008/1/18 Teva v Pharmasure (only one aspect illustrated)

Example of a Case Ruling

Complaint by Teva

Gift was inappropriate as not inexpensive or relevant to the practice of medicine or pharmacy.

Response by Pharmasure

Chocolate hamper was for HCP customers of supplement products, therefore outside the scope of the code. Representative visited hospital after a nurse call and dropped off hamper at same time. 

PMCPA ruling

Breach: because despite lack of discussion on a promoted product, hamper could be linked to a promoted medicine.

The chocolate hamper was not an acceptable item that may be provided to HCPs.

Compliance Programme

All companies should have a robust compliance programme.

  • Copy approval

    All promotional material and activities must be approved.

    Only some non-promotional material and activities must be approved.

  • SOPs
    Companies must have robust operating procedures under which all materials and activities are reviewed to ensure compliance with the code.
  • Governance
    Each company must appoint a senior employee who is responsible for ensuring that it meets the requirements of the code.
  • Quality
    Companies must ensure that their materials are appropriate, factual, fair and capable of substantiation and that all other activities are appropriate and reasonable.
  • Training
    Companies must ensure all relevant personnel are appropriately trained in the requirements of the code (initial and ongoing).

Who Must Comply with the Code?

Departments affected by the Code:

  • Sales
  • Marketing
  • Training
  • Meetings
  • Public relations
  • Public affairs
  • Government affairs
  • Customer services
  • Market research
  • Market access
  • Medical affairs
  • Medical information
  • Outcomes research
  • Clinical research
  • Human resources
  • Finance
  • Global
  • Other affiliates

Who Must Comply with the Code?

Who else must comply with the code?

  • External agencies
  • External contractors
  • Co-promotion partners
  • Joint working projects

Links

Exam

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