Drug test

With proposed reforms set to change the NHS beyond recognition, never has the healthcare - and by association the pharmaceutical sector - been more under pressure. It seems appropriate therefore that Roche Products’ UK and Ireland arm decided to make 2012 the year of change when it appointed Funke Abimbola its first-ever managing counsel for UK and Ireland in January this year. For Richard Daniel, legal and compliance director at Roche, the change was necessary.

Sharing the burden
“I joined Roche in the late 1980s as the sole lawyer for the UK and it was a different world back then,” Daniel says. “As the legal function grew and I took charge of the compliance side we came to the conclusion that we needed somebody else internally to have day-to-day managerial responsibility for the legal team and to take some of the burden off me.”

Abimbola joined Roche from Uxbridge firm IBB. Although she does not have a medical background per se, her practical background in the healthcare sector was a driving force behind her decision to take up the role at Roche, she says.

“As the only non-medic in my family I have practical experience of the healthcare sector,” she laughs. “I also joined for personal reasons and was attracted to the role because of the company’s market-leading position - in particular, its strong reputation in oncology.”

As Abimbola notes, even in the months she has been at Roche there have been a large number of challenges with which she has had to contend.

“There are a number of challenges facing the sector generally, as well as the main Health and Social Care Act 2012 and the changing face of the NHS, and all the uncertainties surrounding this and how it will pan out,” she comments. “It remains to be seen whether it’ll be easier or harder for us to get products on the market.”
Changes in legislation and regulation have also had an effect on the legal team’s work.

“In tandem with changes to the EU data protection law, the health sector has been targeted for enforcement so this has had a big impact on our work,” she says. “Compliance is also a big issue. We have to comply with constant changes by the Association of the British Pharmaceutical Industry (ABPI) to the code of practice, and this affects our ability to promote drugs while maintaining the research and development priceline.”

Based in Welwyn Garden City, Abimbola and Daniel’s team includes four other lawyers and a legal administrator who together support the company’s UK and Ireland commercial divisions and supply chains, as well as providing specific advice on the launches of their products on the market.

Science facts
“There’s such an extensive volume of product information that our team really needs a good understanding of what’s at stake and certain members of the team have scientific backgrounds,” she adds.

As Daniel says, as the UK arm of a global organisation the legal team has to get to grips with the specifics of the UK healthcare sector and all manner of related licensing and compliance issues.

“We have to deal with products that are licensed and ready to go to market, so we have to know what are the restraints and what we can and can’t say to doctors prior to a product being launched,” he says. “Therefore, we have to ensure that what we’re saying to doctors is compliant, so we’re not making any promotional claims.”

Although Roche does not have a fixed panel of firms it regularly reviews its external counsel and Abimbola performed an informal review shortly after joining the company earlier this year.
“We manage our budgets closely, but outsource when we have to,” she reveals. “For any large litigation, when the man-hours and the complexity are too much, we turn to our external law firms.”

In the UK, Roche regularly retains Eversheds for employment and competition matters, as well as some litigation, while Arnold & Porter, Covington & Burling and DAC Beachcroft provide advice on pharma-related issues. Roche uses a range of firms for specific matters, such as Berwin Leighton Paisner for trust and pension advice and Herbert Smith for patent work. In Ireland, its primary legal counsel is McCann Fitzgerald.

“We want to demonstrate the value of having a legal team, acknowledging that it’s just one of many teams and units, so maintaining trusted adviser status with outside firms is key to our success,” she stresses.

For Abimbola, having already had a taste of in-house life during stints at companies such as Wembley plc, Roche suits her fine.

“I enjoy working in-house,” she says. “I’m aware of being more accessible to clients, which I love - it hasn’t been a challenge for me at all. The company’s work and products are close to my heart and I’ve enjoyed hitting the ground running.”