We asked Lourdes Fraguas Gadea, general counsel at Farmaindustria and winner of the Regulatory (Non-financial Services) Individual of the Year award at the 2017 Global Counsel Awards, her opinion on what it takes to be a successful in-house counsel, the best way to advise senior leadership and what winning the award meant to her.

Describe your current role (responsibilities, size of team, structure).

I am the general counsel of Farmaindustria, the Spanish association of research-based pharmaceutical companies. As such, I give legal advice on all issues related to the sector (eg, IP, data protection, R&D, pharmaceutical, public procurement, administrative, commercial and European legislation), both in-house and to all member companies, either directly to their CEOs at the board and governing bodies of the association or to their legal counsels or other top executives. In addition, I represent the sector before the authorities and take part in meetings with policymakers and health, industry and economic authorities to discuss key healthcare issues. I also interact with other associations, such as the Spanish Confederation of Employers' Organisations and other trade associations that represent the interests of pharmaceutical companies.

I head up a team of three highly qualified and experienced lawyers and three experts in the human resources area. I also coordinate the activities of a lawyer in charge of clinical trials and personal data protection legislation in this field (eg, the EU General Data Protection Regulation (GDPR)) and another lawyer responsible for hospital debt and tax issues, who are assigned to the technical and economic departments, respectively. In addition, we provide legal advice and support to the code of practice surveillance unit and are in charge of the secretary of the arbitration committee (under the code of practice committee).

What led you to a career in-house?

I started my legal career in 1992 as a state lawyer and worked at the Spanish Department of Health, the Spanish Medicines Agency and the legal department of the European Medicines Agency in London. After that, I worked at the Department of Finance and for five years at the European Court of Justice (ECJ) as an agent for the Kingdom of Spain. In 2004 – while I was working at the ECJ – I was offered the position of general counsel of Farmaindustria. I had never thought of leaving my job as a government lawyer, but the job description really attracted me to the role. I have been in this position ever since, 13 years now – how time flies…

In your current role, what is the most challenging situation that you have faced? What are the most significant challenges that in-house lawyers are likely to face over the next few years?

Working at the trade association, I have to represent the sector before the regulatory authorities and the government. These are often the most challenging situations. A significant case took place during the economic crisis, back in 2014, when the government was faced with a financial crisis and there was huge pressure over public accounts. A small group of representatives of the sector – in which I took an active part – reached an agreement with the government by which the sector fixed a ceiling to its growth, limiting the growth of public expenditure in pharmaceutical products to the growth of Spain’s real gross domestic product in order to guarantee its economic sustainability.

For the next few years, I see a very important change for the better through the transparency initiatives and corporate compliance. As for potential challenges, I would highlight the GDPR and its effect on the health sector – particularly in clinical trials and clinical practice – and also the implementation of the EU Falsified Medicines Directive. The former will be a challenge to reinforce without setting up too many obstacles for research and progress towards new treatments and medicines; as for the latter, it will be a challenge to prevent falsified medicines from entering the market and reaching patients (and the implied dangers to public health).

Are there particular types of legal issues that you routinely refer to outside counsel? And what kind of matters do you tend to handle in-house?

I only refer court cases to outside counsel, although I define the legal strategy and revise the draft of all papers before their submission to the courts. All other issues are handled in-house.

What do you consider to be the essential qualities for a successful in-house lawyer?

A broad knowledge of all the different laws related to the business and the sector in which the company operates, a capacity to listen and adapt accordingly, agility in giving answers (or at least working on possible solutions to arising problems), responsiveness, effective communication, negotiating skills, loyalty and ethics. I would also add effective communication and interaction with stakeholders, particularly patients’ organisations, institutions and lawmakers.

What’s important for in-house counsel to consider when advising senior leadership?

Being honest and firm, particularly when one has to say no to projects for legal reasons, without fear of their leading position. And also being at hand, helpful and ready to assist whenever required.

How does the legal department contribute to your company’s growth?

The department has contributed to the growth of the sector through its activities and interaction with authorities at all levels and proposals in drafting legislation (regarding innovation, employment, exports, development of new medicines, vaccines, access and sustainability), which have been fundamental to the development of the pharmaceutical industry – as well as advocating for policies with these aims.

With regard to your industry, are there any significant developments worth highlighting?

This industry is devoted to finding treatments and medicines that save lives, turn certain mortal diseases into chronic ones and cure others (eg, Hepatitis C virus and certain cancers). It is impressive to see its evolution towards personalised medicine and its efforts to ensure access to life-saving medicines for people everywhere.

A great challenge at present for the pharmaceutical industry and health services is to demonstrate the value of new medicines by measuring them in terms of health outcomes and, consequently, the economic efficiencies for national health services and the whole economic system.

If not a lawyer, what would you be?

It is very difficult to imagine, but I would probably work at my family´s fashion company, MIRTO, with my father, brother and sister. I always had summer jobs there during my university years and also helped whenever needed (eg, with international fairs). My father founded the company when he was only 17 and continues to work to this day. I am very proud of him and his example of hard work, ethics and loyalty.

What did winning a Global Counsel Award mean to you?

A recognition for 25 years devoted to the law and the industry, immense pride and an even bigger desire to continue working hard and delivering the best possible service.  

The purpose of the Global Counsel Awards is to identify those in-house counsel, both teams and individuals that excel in their specific roles. The primary aim is to reward lawyers for demonstrable achievements across the full spectrum of in-house responsibility, not simply those who have acted on high-profile transactions. To make a nomination for the 2018 awards please click here.