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Spotlight on Compliance - review of the BHBIA's recent seminar

October 2nd, 2020

This seminar, on 22nd September, put the spotlight on what good compliance looks like. The day was aimed specifically at those with a responsibility for compliance within their organisations, to help them make sure that their companies meet the highest professional standards. 

This is the first time we’ve run ethics and compliance training via Zoom and we were pleased to find that the format worked well. Whilst it will never the replace the experience of meeting face to face, we were able to bring together a great line up of expert speakers and make it very interactive.

Speakers and sessions - thanks to all those who contributed
  • The day was chaired by BHBIA Ethics & Compliance Committee Deputy Chair Yuliya Fontanetti, Senior Director, Operations and Compliance, HRW.
  • Catherine Ayland, BHBIA Ethics Advisor and Debrah Harding, Managing Director, Market Research Society (MRS) and Vice President, EFAMRO talked about the latest BHBIA, EphMRA and MRS Codes and also gave an update on data protection and privacy guidance, including international developments. 
  • Emma Elder, Data Privacy Compliance Manager UK & Ireland, AbbVie and Emily Joyce, Data Protection Officer, M3 Global Research shared their ‘day in the life’ of a data privacy specialist. 
  • We then looked at ABPI Code of Practice requirements and how they impact MR with Heather Simmonds, Director, Prescription Medicines Code of Practice Authority giving a PMCPA perspective and Catherine King, Senior Scientific Advisor, LEO Pharma UK talking about key issues from a client company viewpoint. 
  • The day ended with an Open floor 'clinic' session – facilitated by Catherine Ayland and a ‘Future Gazing’ exercise in small groups to discuss what compliance issues are coming up in next 12 - 24 months and how the Ethics & Compliance Committee should consider preparing to meet future compliance needs. 
Discussion points and take-home messages 
  • Privacy is evolving generally and there’s a lot to keep up with – new regulations, new codes and new guidance. Companies may want to consider questions such as: Does your organisation have a privacy culture? What’s your vision/philosophy? 
  • There were some insightful discussions around the definition of Data Controller and the need to name the end client – both sharing what we know to date, and acknowledging that the implications can be complex, and that interpretations vary. It’s clear that this remains a key area where further clarification from the BHBIA may be valuable, and this is something the Ethics & Compliance Committee are looking into right now.
  • The GDPR Sector Code that is in development presents a good opportunity to improve understanding and adherence as an industry. 
  • The PMCPA Session was a useful reminder of aspects we should pay particular attention to, to avoid falling foul of the Code, and the need to step outside of our MR roles to consider how HCPs will receive MR material, but it was reassuring to hear that the ABPI receives few complaints arising from MR. 
  • A useful reminder of valuable resources from the BHBIA and other organisations. This includes both the full suite of Guidelines & Legislation materials and the new Covid-19 Information & Resources hub, which includes, for example, guidance on face-to-face research from the MRS. 
  • It’s clear we need to plan ahead for the end of the Brexit transition period (when data transfer processes and requirements may change) and there are already resources to help us start these conversations (in the Privacy & Data Protection section of the website) and we’ll be running a webinar on 13th November. 

We also learnt some new acronyms! 

  • "Plugging – political lobbying under the guide of MR"
  • "Frugging – fund raising under the guide of MR"
Delegate feedback

Comments from the delegates included: 

 “Great, experienced presenters secured with time for questions” 

“It was good to refresh, but also hear the new updates and what is coming in the next few months. Really found it informative and directive. As there is only one of me in my company it sometimes feels you are adrift, so good to affirm what you have in place and also think of areas of improvement” 

“It was hugely more practical to have it by Zoom and I would prefer that even post COVID, as I could jump straight back into the day job afterwards...” 

“The only downside is the lack of face to face interaction but in many ways it’s easier to take in the content of the presentations via Zoom”