Orphan Europe v Special Products and Chemical Developments: Internet promotion of unlicensed medicines

📊

Key facts

⌄

Case number	AUTH/2108/3/08 and AUTH/2109/3/08
Case reference	Orphan Europe v Special Products and Chemical Developments
Complainant	Orphan Europe
Respondent/company	Special Products Limited; Chemical Developments Ltd
Product(s)	N-carbamyl-L-glutamic acid powder; anhydrous betaine powder
Material/channel	Websites (www.specialproducts.biz; www.chemicaldevelopments.com) including online store/product pages, printed materials and website data sheets
Key issue	Internet promotion of unlicensed medicines, including therapeutic indications and other medical information, and misleading “specials” messaging where licensed alternatives existed
Dates (received/completed if stated)	Complaint received 25 March 2008; Cases completed 5 June 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Breach of Clause 3.1 (both cases); Clause 5.2 alleged but considered covered by Clause 3.1 ruling
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

Download the full case report (PDF)

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

📋

What happened

⌄

Orphan Europe complained about the Internet promotion of N-carbamyl-L-glutamic acid powder and anhydrous betaine powder by Special Products Limited and Chemical Developments Ltd.
In November 2007, the websites www.specialproducts.biz and www.chemicaldevelopments.com provided the same or similar product information and stated the products were available to “buy”.
Neither product was licensed anywhere in Europe.
The websites provided printed materials and data sheets with sections headed “Therapeutic Indications”, listing medical conditions/patients for which the products were indicated, plus further information such as dosages and adverse events.
As of 19 March 2008, the information was still freely available on Chemical Developments’ website, despite a 7 January 2008 letter stating the site had been temporarily removed since December 2007 while changes were made.
On Special Products’ website, information on N-carbamyl-L-glutamic acid powder appeared to have been removed, but full prescribing information/advice/indications remained available for anhydrous betaine powder (accessible by clicking a button indicating the user desired the information).
Special Products’ homepage included a bold strapline: “Specials” are unlicensed medicinal products prescribed by doctors when a licensed product for a particular illness does not exist.
Orphan Europe stated licensed products did exist in the same presentation for the same indications (Carbaglu and Cystadane), for which Orphan Europe SARL held the marketing authorizations and which had EU orphan drug status.
Special Products stated it had instructed the hosting provider to disable the ChemicalDevelopments.com website in December 2007; it said the site appeared inaccessible via the main URL but could still be accessed via product-specific searches, which it said was closed once notified. Special Products apologised for the oversight.
Special Products stated that for its own site, users had to be health professionals, register, be vetted, and use a username/password; it argued this meant it was responding to requests for information in line with MHRA guidance on specials.

⚖️

Outcome

⌄

Chemical Developments (AUTH/2108/3/08): The Panel decided that, via its website (including depiction of a health professional and inclusion of medical information), Chemical Developments was acting as a pharmaceutical company and was subject to the Code.
Chemical Developments (AUTH/2108/3/08): The Panel ruled that the website material (dated 19 March 2008) amounted to promotion of medicines without marketing authorizations and ruled a breach of Clause 3.1.
Special Products (AUTH/2109/3/08): The Panel considered Special Products was a pharmaceutical company subject to the Code (it described itself as a wholesale pharmaceutical company, held an MHRA wholesale dealer’s licence, and worked to convert specials into licensed products).
Special Products (AUTH/2109/3/08): The Panel did not accept that use of a password to access product information meant the company was merely responding to requests.
Special Products (AUTH/2109/3/08): The Panel ruled that the material promoted an unlicensed product (anhydrous betaine powder) and ruled a breach of Clause 3.1.
For both cases, the Panel considered the Clause 5.2 allegation (abbreviated advertisements on the Internet) was covered by the Clause 3.1 ruling in the circumstances described.

🔒

Unlock the full case analysis

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access

Orphan Europe v Special Products and Chemical Developments: Internet promotion of unlicensed medicines

Key facts

What happened

Outcome

Unlock the full case analysis

📰 Weekly PMCPA Case Breakdown