๐ŸŸข Therapy Area Compliance Pack ยท Rare Diseases

Rare Diseases Compliance Pack

With Ozempic, Wegovy, Mounjaro and Zepbound dominating headlines, obesity is the highest-risk therapy area for PMCPA complaints in 2024โ€“25. This pack arms your medical, commercial and compliance teams with everything they need โ€” before a complaint lands.

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Instant access ยท ABPI Code 2024 ยท Rare diseases-specific guidance ยท Includes PMCPA case analysis

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High-alert therapy area: Rare disease products operate in a high-scrutiny environment โ€” small trial populations, named patient use and patient advocacy group activity create compliance risks that standard frameworks do not always anticipate.

The specific risks your rare disease team faces right now

๐ŸŽฏ High Risk

Off-label weight-loss promotion

Promoting GLP-1 medicines beyond their licensed indication โ€” or allowing third parties to do so โ€” is the single largest source of complaints. Includes social media, influencer content and patient group materials.

๐Ÿ“ข High Risk

Comparative & superiority claims

Head-to-head efficacy comparisons between GLP-1 agents without robust data, or claiming "best in class" outcomes, have attracted multiple PMCPA rulings since 2022.

๐Ÿ’ป High Risk

Social media & disease awareness

Posts about obesity as a disease that are seen as disguised brand promotion โ€” particularly where product-specific hashtags or links are present โ€” are a growing source of complaints.

๐Ÿฅ Medium Risk

NHS access claims

Statements about NICE approval, NHS commissioning status or formulary listing must be current, accurate and not create an implication of superiority over alternatives.

๐Ÿ“„ Medium Risk

Patient organisation relationships

Funding, content approval and disclosure requirements for patient advocacy groups are frequently mishandled in the obesity space given the level of patient advocacy activity.

๐Ÿ”ฌ Medium Risk

Clinical trial data & publications

Obesity trials often involve multiple endpoints and doses. Cherry-picking data or promoting trial results before licence extension is a significant risk.

Everything your team needs in one pack

Built specifically for pharma teams working in the rare diseases space โ€” not generic compliance content repurposed for your therapy area.

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Obesity Compliance Module
45-minute e-learning module covering the six high-risk areas above, built on the ABPI Code 2024 with Rare Diseases-specific examples throughout.
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Curated PMCPA Case Analysis
All relevant PMCPA adjudications involving GLP-1 medicines and obesity products, with expert commentary on the practical lessons for your team.
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Therapy Area Risk Profile
A structured risk assessment document mapping your team's activities against the highest-risk promotional practices in obesity โ€” ready to take to your compliance committee.
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Rare Diseases Compliance Checklist
A pre-approval checklist for promotional materials, social media posts and patient organisation activity in the obesity space.
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Podcast Episode
A 30-minute podcast episode covering the most important PMCPA cases and compliance pitfalls โ€” perfect for team meetings or the commute.
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CPD Certificate
Learners who complete the module and pass the assessment receive a CPD certificate with their name, score and date.
Rare Diseases Compliance Pack
ยฃ599
per learner ยท annual access
Less than a single half-day workshop
  • โœ“ Rare Diseases Compliance Module
  • โœ“ PMCPA case library โ€” obesity filtered
  • โœ“ Therapy area risk profile document
  • โœ“ Pre-approval compliance checklist
  • โœ“ 30-min podcast episode
  • โœ“ CPD certificate on completion
  • โœ“ 12 months access
Request Access โ†’

Obesity cases that every team should know

The pack includes expert walkthroughs of all relevant PMCPA adjudications in the obesity space. Here are three landmark cases.

Social Media & Digital
AUTH/3497
Novo Nordisk ยท 2023
Upheld

Social media disease awareness posts were found to be disguised promotion of semaglutide. The company was required to take remedial action.

Off-label Promotion
AUTH/3620
Eli Lilly ยท 2024
Upheld

Materials referencing weight-loss data were found to be promoting tirzepatide beyond its licensed indication for T2D at the time.

Comparative Claims
AUTH/3211
AstraZeneca ยท 2022
Upheld

A claim of superior cardiovascular outcomes in the obesity setting compared to a named competitor was found to be misleading and unsupported by the cited data.

The pack includes all relevant obesity PMCPA cases with video walkthroughs, expert commentary and quiz questions.

Built for every function in your your rare disease team

๐Ÿ’Š

Medical Affairs

MSLs and medical advisors interacting with HCPs on GLP-1 data, publications and off-label requests

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Commercial Teams

Sales reps and marketing managers responsible for promotional materials and CRM communications

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Market Access

HEOR and market access teams making NHS/NICE claims in promotional and non-promotional materials

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Regulatory & Compliance

Regulatory affairs and compliance officers signing off obesity materials and providing guidance to teams

Ready to reduce your obesity compliance risk?

Speak to us about the Obesity Compliance Pack. Tell us your team size and therapy area focus and we'll put together the right package.

Individual
ยฃ599
per learner ยท 12 months
Request Access โ†’
Team
POA
bespoke quote ยท bulk seats
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Looking for more therapy areas? Contact us about upcoming packs โ†’

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