United Kingdom – The Register – August 22, 2011
The Prescription Medicines Code of Practice Authority (PMCPA) said that Bayer Healthcare had violated the Association of the British Pharmaceutical Industry Code of Conduct (ABPI Code). The Code sets rules on what companies can say when informing the public about prescription-only medicines.
Bayer was in breach of the parts of the Code which prohibits the advertising of prescription-only medicines to the public, the PMCPA said. The company also breached a rule that prohibits companies releasing information about prescription-only medicines that would encourage the public to ask their doctor for the product. Bayer also failed to maintain high standards and brought discredit upon, and reduced the confidence in, the pharmaceutical industry – two other rules written into the Code.
An advertisement publicising Bayer’s case was published in The Nursing Standard on 17 August. Further adverts will run in the British Medical Journal and The Pharmaceutical Journal on 20 August.
The PMCPA rules state that it must advertise brief details of all cases where companies bring discredit upon and reduce confidence in the pharmaceutical industry, or when companies are forced to issue a corrective statement or are the subject of a public reprimand.
Last year Bayer copied headlines from press releases it had formed about the launch of two products and sent them out as two tweets to its Twitter followers, according to the PMCPA ruling (3-page/42KB PDF). One of the tweets did not name the product but “referred to its qualities, indication and launch”, while the other tweet “mentioned the brand name, indication and launch”, the PMCPA said.
“The Panel considered that each tweet was in fact a public announcement about the launch of a prescription-only medicine which promoted that medicine to the public and would encourage members of the public to ask their health professionals to prescribe it,” the PMCPA said in its case summary.
“Breaches of the Code were ruled in relation to each tweet as acknowledged by Bayer. The Panel considered that high standards had not been maintained,” the summary said.
“The Panel was concerned that material placed on Twitter had not been certified. That the original press releases were certified was insufficient in this regard. If part of a certified document was reproduced in a different format or directed to a different audience the new material should be certified separately. The Panel was extremely concerned that controls within the company were such that uncertified information about the launch of prescription-only medicines had been posted on Twitter. A breach of [The Code] was ruled,” the summary said.
The self-regulatory Code sets out rules based on compliance with UK laws, including The Medicines (Advertising) Regulations 1994. The regulations were introduced in the UK to implement an EU Directive, the “Community code” relating to medicinal products for human use. Civil and criminal sanctions exist for serious breaches of the regulations.
“Pharmaceutical companies must comply with the ABPI code of practice and have in place sufficient checks and regulations to ensure that breaches of the code such as this do not occur,” Camilla Balleny, legal expert in life sciences at Pinsent Masons said.
“Digital media is moving at such a pace that companies must be on the look out for ways in which issues such as this might breach the code in way not previously envisaged,” Balleny said.
“It seems that the problem in this case arose because of extracts from ‘approved’ announcements of the launch of two new medicines being posted on Twitter in circumstances where Bayer could not verify that the only people who could access the extract were healthcare professionals. The extracts were such that they were considered to be advertising, and in particular, likely to encourage members of the public to ask their health professional to prescribe a specific prescription. Advertising to healthcare professionals is not restricted per se, although the content of such advertisements is still heavily scrutinised for balance and truth,” Balleny said.
In April this year the PMCPA released guidance notes on how companies could use digital media without falling foul of the ABPI Code. Balleny said that inconsistencies exist in global rules governing the advertising of medicines, which makes it difficult for pharmaceutical companies that make information available online.
“In the US the advertising of medicines to the public is permitted. This is in contrast to the restrictions in Europe. This difference has long been a problem for pharmaceutical companies looking to develop website content which reaches around the world and it has led to, for example, the development of healthcare professionals-only websites,” Balleny said.
“Based on the recent PMCPA guidance, if pharmaceutical companies wish to use Twitter from a UK perspective, there is going to need to be tighter restriction on the content, in circumstances where the identity of the signatory cannot be verified,” Balleny said.