New CBI Report - Smooth Operations - Highlights Importance Of Getting EU Rules Right For Life Sciences

CBI seeks to inform Brexit negotiations by outlining where British businesses want to stay close to EU rules and where they want divergence

‘The task of unpicking 40 years of economic and regulatory integration is complex and colossal’, CBI Director-General Carolyn Fairbairn warns at the launch of a new CBI report on EU rules that matter for the UK economy.

Smooth Operations is based on thousands of conversations with UK businesses, as well as dozens of leading trade associations, and provides an A to Z of the rules that will matter after the transition period. From architects to zoos, it outlines the regulatory needs of 23 industry and service sectors, of which 18 prefer convergence or alignment for the majority of regulation that matters.

The CBI study, compiled over a six-month period, says Brexit presents opportunities for rule changes in sectors such as agriculture, shipping and tourism that could ultimately benefit the British economy and consumers.

However, the report adds that opportunities for divergence are vastly outweighed by the costs of deviating from rules necessary to ensure smooth access to the EU market.

Another important finding is that changes to rules in one sector have significant knock on effects for companies in other sectors and throughout supply chains. The main regulatory needs of the life sciences sector are:

• Continued convergence with every stage of the EU rules that govern the production and sale of medicine, and key regulation on medical devices that are in the process of being implemented, is critical to maintain patient safety
• Convergence with EU rules that maintain co-operation in the authorisation of medicines and the updated Clinical Trial Regulations, are vitally important to make access to medicine quicker, cheaper and safer.

George McFarlane, CBI Sector Development Director, said:

“This report comes from the heart of British business. It provides unparalleled evidence to inform good decisions that will protect jobs, investment and living standards across the UK.

“The experience-based evidence of companies across the country will be essential in the months ahead, as it is critical that negotiators understand the complexity of rules and the effects even small changes can have.

“The UK’s life sciences sector is a key driver of prosperity in the UK and a renowned global success story. As well as its significant economic contributions, the sector plays a critical role in tackling some of the most significant challenges of our time, including treating cancer and seeking to halt dementia through its research and development functions.

“To ensure patients can access the latest medicines in a timely and safe manner, convergence with existing EU regulation is critical. The UK is a crucial player in the sector’s regulatory framework and its departure would significantly impact the EU.”

Steve Bates, CEO of the BioIndustry Association, said:

“It is vital that regulatory alignment for medicines is a priority in the Brexit negotiations. This is imperative to protect public health by ensuring that the supply chain, from discovery and development to reaching patients on both sides of the channel, is not disrupted.”

Mike Thompson, CEO of the Association of the British Pharmaceutical Industry, said:

"Every month, 45 million packs of medicines move from the UK to the EU, with 37 million coming the other way. As we look to the next phase of the negotiations, it’s now critical that both sides prioritise patient safety. 

“Making sure the supply of medicines is uninterrupted is essential to ensure patients in the UK and EU can get the medicines they need from day one of Brexit. Therefore, the best way to safeguard patient safety and protect public health in the UK and EU is to ensure we continue to cooperate on the regulation, trade and supply of medicines as the UK leaves the EU.” 

11 April 2018

Notes to Editors

• You can download the full report here: http://www.cbi.org.uk/insight-and-analysis/smooth-operations/
• A sector-by-sector summary of rules and regulations desired by businesses as part of the CBI’s extensive consultation can be found at the start of the report.
• David Davis, Secretary of State for Exiting the European Union, gave a speech in February promising to “continue our track record of meeting high standards, after we leave the European Union”, adding:

“We start from a position of total alignment, with unprecedented experience in working with one another’s regulators and institutions.

“The agreement we strike will not be about how to build convergence, but what we do when one of us chooses to make changes to our rules.”

About the CBI

Across the UK, the CBI speaks on behalf of 190,000 businesses of all sizes and sectors. The CBI’s corporate members together employ nearly 7 million people, about one third of private sector-employees. With offices in the UK as well as representation in Brussels, Washington, Beijing and Delhi, the CBI communicates the British business voice around the world.

Media Contact:

CBI Press Office is available 24 hours a day on 0207 395 8239, or email: [email protected]. Follow the CBI (@CBItweets) and Carolyn Fairbairn (@CBICarolyn) on Twitter.