PMCPA Annual Report 2016 Press Release

There was an increase in the number of complaints in 2016 (76, compared with 54 in 2015) which led to 100 cases (compared with 66 in 2015).  Some complaints gave rise to more than one case, as they involved more than one company.  The number of individual allegations (matters) considered in 2016 was 420, compared with 198 in 2015.

There was an increase in matters appealed in 2016 (33) over 2015 (19).  Of the 33 matters appealed in 2016, 15% were successfully appealed and 85% failed.

The PMCPA publishes detailed reports on its website of the outcome of all complaints considered under the ABPI Code of Practice for the Pharmaceutical Industry.  The PMCPA Annual Report gives an overview of all the Authority's activities in 2016, including the source of complaints, the outcomes, the sanctions applied and the time taken to consider cases. 

The PMCPA administers the Association of British Pharmaceutical Industry (ABPI) Code of Practice for the industry. It covers the promotion of medicines for prescribing by the industry to health professionals and sets standards for interactions between them. It requires companies to ensure that activities and materials are appropriate, factual, fair and capable of substantiation.

Complaints received in 2016

Complaints are received from a variety of sources, including health professionals and pharmaceutical companies.  Anonymous complaints are accepted but, as the complaints system is designed to allow both parties to fully participate, it is regrettable that many of the anonymous complainants did not provide any contact details.  

Complaints nominally attributed to the Director nearly doubled (15 in 2016 vs 8 in 2015) mostly due to an increase in the number of companies making voluntary admissions (13 in 2016 vs 4 in 2015). The fact that companies make voluntary admissions indicates the seriousness with which the industry takes the Code.

Some of the voluntary admissions by UK companies relate to activities of companies located outside the UK but still in Europe (regional/European offices) which carry out activities with UK health professionals. It is of concern that some of these activities, when ruled in breach of the ABPI Code are also unlikely to meet the requirements of other relevant codes in Europe. The PMCPA is following this up with other organisations including EFPIA (European Federation of Pharmaceutical Industries and Associations).

Complaint rulings

Fifty seven per cent of cases were ruled in breach in 2016, an increase compared with 53% in 2015. However, if based on the individual matters the percentages are similar for both years, at around 43% in breach. 

The PMCPA Panel continues to have a good record with 99% of its rulings in 2016 being accepted by the parties, or upheld on appeal, the figure for 2015 was 97%.  The parties accepted without appeal 92% of the Panel's rulings, compared with 90% in 2015.  The Appeal Board has no hesitation in overturning the Panel's rulings where appropriate.

Sanctions

In each case where a breach of the Code is ruled, the company concerned must give an undertaking that the practice in question has ceased forthwith and that all possible steps have been taken to avoid a similar breach in the future.  An undertaking must be accompanied by details of the action taken to implement the ruling.  Additional sanctions can also be imposed and may include:

• an audit of a company's procedures to comply with the Code. This can possibly be followed by a requirement that promotional material be pre-vetted for a specified period
• requiring the company to take steps to recover items from those to whom they have been given
• requiring the company to issue a corrective statement
• a public reprimand
• suspension or expulsion from membership of the ABPI.

The PMCPA advertises in the medical and pharmaceutical press brief details of all cases where companies are publicly reprimanded, are required to issue a corrective statement or are ruled in breach of Clause 2 of the Code for bringing discredit upon or reducing confidence in the pharmaceutical industry. Advertisements are also published on the PMCPA website.

In June 2016 an ABPI member company was suspended from membership of the ABPI by the ABPI Board. This was the first time that this sanction had been used since 2008.

The Annual Report gives details of the use of other sanctions including corrective statements, audits and public reprimands. 

Timings

The time taken to complete cases settled at Panel level in 2016 was 10.4 weeks, an increase compared with 2015, at 8.5 weeks. The Panel is extremely conscious of the need to deal with cases as quickly and efficiently as possible. Many cases however required additional information before the Panel could make a ruling.