Innovative healthcare products driving increased demand for legal advice

The emergence of cutting-edge healthcare technology is rendering current legal frameworks obsolete, while the sector is also generating significant levels of transactional work

Spanish lawyers specialising in healthcare-related matters are experiencing an increase in demand for their services as the country’s existing legal frameworks are unable to keep pace with the speed at which innovative new products are being introduced into the market. As a result of this trend, law firms have identified the healthcare sector as one of the major potential growth areas.

“Research and development investment and [healthcare] breakthroughs have created a scenario in which new companies are being incorporated that aim to provide innovative services and products,” says Jorge Robles, partner at Cuatrecasas. “For example, we now see that an app for our cellphone can be considered a medical device.”

He adds that the pace of research and development in the healthcare sector means clients increasingly need lawyers to ensure new products are in accordance with legislation. Robles says legal advisers are having to “present complex legal solutions that comply with a usually obsolete legal framework”. He says European laws governing such developments have added a further layer of complexity to this issue.

Meanwhile, data privacy, including advice on apps, software, IT platforms and ‘e-medicine’ is another growing area of work being generated by the healthcare sector, according to Cecilia Pastor, partner at Baker McKenzie and head of the firm’s healthcare practice. She adds that the emergence of new operators in the market is creating a considerably more regulated environment for the existing players. “[There is] incremental complexity, with new market players crossing over from other sectors (such as IT) and globalisation, pressure on price as part of cost contention, decreasing margins, incremental regulatory and investigation costs, as well as incremental supervision from the authorities (including regulatory and industry authorities) and a deeper exposure through social media,” Pastor says.

Robles argues that this new environment means the role played by legal advisers is changing. “[Our] role is evolving into not being just an expert in the applicable laws, but to act as a link between the healthcare companies, the judicial system and the public authorities.”

Meanwhile the emergence of increasingly innovative healthcare-related products, as well as more onerous requirements related to regulatory compliance are key issues for Portuguese healthcare providers, in both the public and private sectors. “Access to innovative products by patients within the public healthcare system has triggered the introduction of new and more complex legislation related to health technologies assessment, as well as the need for players to have robust legal advice regarding the launch of a new product into the market and negotiation with public stakeholders,” says Rita Roque de Pinho, of counsel at PBBR.

Pharma companies restructuring
Lawyers say Portugal’s strict rules around healthcare promotion and advertising in particular are providing a solid pipeline of work. “[These have] produced evident restraints on pharmaceutical companies’ business activity and lead some to reframe and restructure their activity in Portugal,” explains Fernanda Matoso, partner at MLGTS.

Meanwhile, lawyers specialising in healthcare in both Spain and Portugal report healthy levels of transactional work, particularly for multinational clients operating in Iberia. Significant recent transactions included Grifols €1.7 billion acquisition of Hologic’s blood screening business. Grifols was advised by Osborne Clarke and US law firm Proskauer Rose on the deal. Hologic instructed Gibson Dunn & Crutcher. With regard to other practice areas, corporate restructurings, contract negotiations and related litigation are also leading to a raft of instructions for lawyers, according to Pastor.

Robles anticipates that there will be a further growth in demand from healthcare sector clients for legal services. He adds: “The challenges of innovation and new regulations will surely lead to an even bigger increase in legal advice requests.”