My legal life: Helen Roberts

At university I discovered European law, after science and maths. This led me to study both English and French law at King’s and the Sorbonne. French law forms the basis of European law concepts and I was fortunate to study IP law, administrative regulatory law and company law in both systems. Interestingly, the new Unified Patent Court procedures will soon test how to combine common law and civil law approaches to IP litigation and presenting evidence.

At Clifford Chance in London and Paris I found that the law is unique in adding value to business and society.

As a member of a UK regulator of medicines for 10 years, I can say that the law has proved its resilience in dealing with complex ethical and regulatory issues.

In my legal training I advised both innovator and generics businesses, gaining valuable insights into defending and challenging IP rights, regulatory strategies and exclusivities. Negotiating agreements with authorities across the EU to pay for medicines led me to advise on pricing and reimbursement.

BonelliErede’s development of the law on EU life-sciences regulation is presciently innovative.

The hardest challenges include advising clients to compliantly strike the right balance between shareholder and customer interests. In increasingly transparent industries, this is key.

I once advised on the successful conclusion in two jurisdictions of three separate civil, criminal and fiduciary investigations into the purchase of a multi-million-pound business, then on closing down the business – all in three months.  

European and national regulators have transformed the legal landscape. Electronic litigation and e-discovery are now usual. Lawyers must be ready to use more than one set of sophisticated tools in gathering evidence, negotiating with regulators and assessing risks.

At EU level, a highlight was developing innovative interpretations of Orphan Regulation EC 141/2000 that led to extended exclusivity, that competitors unsuccessfully challenged before a profitable IPO. Law and science prevailed.

I acted on the first successful appeal against a decision by the National Institute for Clinical Excellence. It sought to reject funding Eloxatin for colon cancer. It was personally poignant, as relatives and friends had died from this cancer.  

In business my twin passions are finding productive solutions to business and ethical challenges, and generating value for shareholders and customers. We need to show how investing in legal proceedings or advice creates business and shareholder value. As a lawyer I’ve learned to be ready to ask questions and learn from others.