5 October 2016Big Pharma

LSIPR 50 2016: Galit Gonen

Name: Galit Gonen

Organisation: Teva Europe

Position: Senior vice president and general counsel

Galit Gonen is the senior vice president and general counsel for Teva Europe. Based in Israel, Teva is a generics company but also makes branded products. “Teva takes an innovative and enthusiastic approach to our business; it is work around the clock but I really love what I do,” she said on Teva’s website.

She spoke to LSIPR to explain more about her work.

What does your role entail?

I lead the European legal group, which includes local and regional functions, and my role broadly covers providing legal support to the speciality and the generic businesses in Europe.

"In my view, our role is to listen to the business, come up with smart and creative strategies and then to make sure that it is well informed so that it is equipped to make final decisions about the business operations."

Working on both sides (speciality and generics) enables my team to become better lawyers and pre-empt the other side’s strategies. We handle a variety of legal issues such as patent challenges, regulatory litigation and exclusivity issues, market access support, parallel imports, tender legislation and competition law matters.

What is your biggest achievement to date?

My biggest achievement so far was building an integrated European legal department with lawyers from many different countries, cultures and experience who now work tightly together as a team, support each other, share information, and aspire to create value for the business.

Lawyers are typically the guardians, the first to say ‘no’ to the business: ‘you cannot launch since you will infringe this patent …’. However, my and my team’s approach is always to try and say ‘yes’ by coming up with creative strategies and working closely with the business to understand what it wants and needs. We should then make proposals on how to achieve what it wants and review with it the risks involved.

In my view, our role is to listen to the business, come up with smart and creative strategies and then to make sure that it is well informed so that it is equipped to make final decisions about the business operations. We are its partners and we work hard on being its trusted advisers.

What was the biggest challenge while working towards this?

Becoming a unified legal department that is spread across many European countries and works together to be the best business partners and value creators to the business was not an easy task. The lawyers in my team come from different backgrounds and expertise, different cultures and languages, and work from many locations in Europe.

How did you overcome it?

I had to overcome these gaps, work hard to bring people together, form strong relationships and build platforms for education, cooperation and information sharing.

I now believe that I have transformed our legal role from being only a support function into a true partner and a value generator for the business. Our focus is on how we can deliver the greatest value for the business given our budget and the strategic goals set out by the board.

That requires me to really understand our commercial strategies, work with the business leaders to find solutions to barriers to market access and revenue generation, and identify opportunities for growth arising from changes in the law. I also require a true partnership with the business, understanding our place as a support function.

In my role I oversee all EU legal activities, and in balancing all the conflicting commitments of work having a good team which I can completely trust is essential: I have to be able to delegate with confidence. Relying on my team to ensure I am briefed properly and get pulled into appropriate matters is also important.

What do you consider to be the biggest challenge in your field today?

Healthcare budgets are becoming more and more stretched and accordingly all payers are getting more sophisticated. This affects our business operations on both the speciality and the generic sides. It also means that on the legal and IP fronts we need to find new ways of giving the company a competitive edge so that we are able to continue supplying high-quality medicines at the appropriate affordable prices to patients.

"We are living in very interesting times and this trend affects market access and requires an advanced legal support starting from making the deals, dealing with regulatory issues and data protection, ensuring exclusivity when deserved, litigating patents and more. My next achievement will be to embrace this trend."

Additionally, there has been much more competition over the last few years, but this is tempered by the fact that merger and acquisition activity is also reducing the number of competitors. This means that we need to be smarter in our legal strategies and be ahead of the competition, which is achieved by combining IP strategies with regulatory, market access and research and development strategies, working closely with the business to find where we can creatively leverage legal strategies to benefit our business and the patients.

Furthermore, companies today are going beyond the pill and focusing on providing patient outcomes, and this goes past the innovation we’re seeing in the development of pharmaceuticals themselves and how they’re manufactured. Medical technology (or medtech) is manifesting in the pharma market by way of smartphone apps, wireless sensors and wearable devices that monitor patients’ vitals and provide them with a better, more holistic picture of their health. A significant challenge for a pharma company that wants to grow and lead is how to embrace this trend and become a leader in it.

As far as IP is concerned, at present patent litigations are conducted in each European market rather than centrally. This creates huge challenges. The business considers Europe one market. Ensuring pan-EU market access where legal precedents, judicial attitudes, procedures and outcomes may differ from member state to member state is a huge challenge. Factor in differing rules around pricing and reimbursement and the complexity increases significantly.

The IP field is very dynamic and it made me realise a couple of years ago that IP cannot live in isolation. There is a close interplay with interfacing legal subject matters such as regulatory law and data exclusivity, market access, parallel import case law, competition law and tenders legislation. We should always look holistically at a product to come up with the best overall litigation strategy for the business. This holistic view has changed my and my team’s work and has proved successful.

What do you hope your next achievement will be?

I can certainly see technology transforming pharma in the next five to ten years. I think we will see more and more pharma companies buying or partnering with technology companies. Likewise, I think we’ll also see tech companies entering in the pharma market by way of investing in biosimilars, a process whereby a biologic medical product is copied and manufactured by a different company.

We recently saw this with Samsung entering in a big way to capitalise on its tech manufacturing and consumer channels skills. Also this year Google has presented a paper in collaboration with Stanford University suggesting ways to improve the prediction of drug activity in diseases.

We are living in very interesting times and this trend affects market access and requires an advanced legal support starting from making the deals, dealing with regulatory issues and data protection, ensuring exclusivity when deserved, litigating patents and more. My next achievement will be to embrace this trend and together with my group become a legal expert who is able to support the global business on its way to becoming a leader in this field.

Do you have any advice for anyone looking to break into your field?

Litigation experience is important. Having a background in managing and coordinating large, multi-jurisdictional projects is often a given for working in-house.

Furthermore, an excellent familiarity with the business, its operations, its desired goals and its model is a key to success since the IP law and case laws are tools to develop the business and they can be successful only when there is a perfect match and excellent understanding of the business by the legal team.