The following queries have recently been raised with the Ethics & Compliance Committee:

In response to these we have added new questions to our Privacy and Data Protection / Legal and Ethical Guidelines FAQs on the issues of:

• ABPI Code of Practice - Clause 9.10 – requirement to name the pharmaceutical company
  
• Using legitimate interests as a lawful basis for processing personal data
  
• The content of concept and message stimulus material for MR testing
  

Q. The BHBIA’s Legal and Ethical Guidelines state that the end client (usually a pharmaceutical company) has to be named in some market research circumstances but the ABPI Code of Practice says the pharmaceutical company does not need to be named, why is the BHBIA’s guidance different to the ABPI’s?

A. ABPI Code of Practice - Clause 9.10 – requirement to name the pharmaceutical company

Clause 9.10 of the ABPI Code states that market research material need not include the name of the sponsoring company. As ‘blanket’ guidance this is not correct, there are some circumstances where there is a legal requirement to name the pharmaceutical company (the market research end client). The ABPI Code is correct in that there is no ABPI requirement to name the company but that this does not mean there is never a need to name the company. Data protection law requires that the company is named if they are a) the data controller or b) the source of respondents’ personal data or c) recipients of respondents’ personal data. There is no need to name the company sponsoring the market research unless there is a prior legal requirement. We have raised this with the PMCPA and hope that they will clarify the ABPI Code on this issue.

The BHBIA’s guidance on data protection requirements and their impact on naming the client company is detailed within the BHBIA’s Legal and Ethical Guidelines July 2018, on page 10, in section E4.2

Q. Is consent the only lawful basis that can be used for the processing of personal data for market research or data analytics purposes?

A. Using legitimate interests as a lawful basis for processing personal data

There must always be a lawful basis for the processing of personal data and within market research consent is the most frequently used lawful basis but it is not the only available option and it may not always be the most appropriate. Market researchers and data analysts may be able to process personal data on the basis that it is necessary to the ‘legitimate interests’ of the data controller (e.g. the commissioning client company) or a third party (e.g. a fieldwork agency acting on behalf the client). Using legitimate interests as a legal basis to process personal data requires that you must be able to justify why the processing is necessary to pursue the Data Controller’s commercial or business objectives. This need must be balanced against the rights of the individual and what is fair and reasonable for them.

Legitimate grounds may be an appropriate legal basis for processing an individual’s personal data, when for example:

• A commissioning client company provides a list of customer names (originally collected for marketing purposes and held on a customer database) to an agency to draw a sample from for the purposes of customer satisfaction MR or awareness and usage work
  
• Third party data (e.g. provided via social media) is used for a secondary MR purpose (such as the MR analysis of contributors’ comments), assuming that MR is a compatible purpose
  

The ESOMAR and UK Market Research Society (MRS) provide the same advice to their members (https://www.mrs.org.uk/pdf/EFAMRO_ESOMAR_MRS%20GDPR.pdf).

Indeed they explicitly state that: In line with previous opinions of WP29 (under the current Data Protection Directive) market, opinion and social research on client’s customers is) within the reasonable expectations of customers. So although research is not specifically mentioned in the GDPR as a legitimate interest (although direct marketing is) it is expected that market, opinion and social research activities will fall within this ground.

The BHBIA’s GDPR update on the Legal Grounds for Data Processing is available on the BHBIA website - Privacy & Data Protection section - and includes further detail on the use of legitimate interests as a lawful basis for data processing.

Q. Can we test concepts in market research that could not be used in promotional material?

A. The content of concept and message stimulus material for MR testing

It is important to be clear that the content that may be included in market research (MR) stimulus material (e.g. product concepts). is not bound by the same regulations as the content of promotional material that is to be published. The ABPI Code of Practice makes it clear that promotional materials must meet tightly defined requirements (Clause 7 Information, claims and comparisons).

Market research stimulus materials must be fit for purpose and the reasons for its use clearly and directly linked to the MR objectives. In addition, respondents must also be made aware when they are providing feedback on draft materials, hypothetical scenarios, assumptions, a product in development or an unlicensed indication. However the BHBIA’s guidance for reviewing/approving MR materials developed in conjunction with the ABPI makes it clear that on occasion it may be appropriate to test material that would not be suitable for publication but is nonetheless a valid proposition for MR testing and provides the following example:

• “Drug X truly understands the everyday feelings and emotions associated with condition Y and its treatment” - This is a concept statement. It is intended to encapsulate the underlying emotional benefit that could support the brand’s positioning – to test whether this feeling could resonate with an audience would be reasonable. This wording would not however appear in any promotional pieces but the market research could help define the tone of promotional literature.
  

The BHBIA’s Guidance for reviewing/approving market research materials was developed in conjunction with the ABPI specifically for non-market researchers involved in reviewing and approving MR and is available in the Online Training section of the website.

Furthermore, the ABPI Code of Practice states that MR stimulus material should be examined by the commissioning client company to ensure that it does not contravene the ABPI Code (Clause 12 Supplementary Information). Promotional material requires certification (Clause 14.1), certification is not required for MR stimulus material.

Disclaimer:

The BHBIA’s Ethics & Compliance Committee is providing this guidance as general information for its members. It is not legal advice and should not be relied upon as such.  Specific legal advice should be taken in relation to any specific legal problems or matters.  Whilst every reasonable effort is made to make sure the information is accurate, no responsibility for its accuracy or for any consequences of relying on it is assumed by the BHBIA.  We do expect to update our guidance on the GDPR as more information becomes available.