The cornerstone of the new ABPI Code of Practice is the concept of Collaborative working – which includes joint working, donations and grants, while breaking down the Medical and Educational Goods and Services (MEGS) umbrella into its constituent elements.
Collaborative working is when the industry works with the system to relieve it and provide other benefits to the health service. Post-Covid there is a real drive to support the management of patients at home. It is in the interest of the NHS and the Pharmaceutical Industry to work together on programmes to deliver continued quality service in a home setting. Which then improves the capacity of the NHS to treat patients with other diseases.
Pharmaceutical Companies will need to reconfigure their processes to suit the new code and will need new standard operating procedures to cover activities such as collaborative working and new documentation to reflect changes in language in the new code. For example, everything that falls with Collaborative working must be certified and non-interventional study protocols are among the activities that will now need a signatory for the first time.
Most requirements of the new Code came into force on 1 July 2021, however, there is an additional grace period until December 31 for companies to realign their ongoing MEGS activities to donations or collaborative working.
Please contact info@lslaw.co.uk for more information on ABPI – New Code of Practice 2021 and how our legal specialists can ensure that your business has the correct operating procedures and processes in place to ensure compliance with the new code.
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The link to see the ABPI Code of Practice 2021 in full – https://www.abpi.org.uk/publications/code-of-practice-for-the-pharmaceutical-industry-2021/
We hope this article was of interest, but please be aware it does not constitute legal advice.