Lifescience specialists from across the world gathered in Amsterdam for the annual CMS Global Lifesciences Forum on 10 November 2014 to discuss the future of the industry. This report summarises some of the key legal issues our clients are facing in the sector, including regulatory, fundraising, and development opportunities in new markets and technologies.
Medical device companies must take advantage of opportunities in eHealth and overcome challenges of exporting.
If the medical devices industry is to keep pace with a technological landscape that is increasingly putting power in the hands of customers, big businesses must embrace the benefits of electronic health and innovate in the same way as technology competitors. Small players will see challenges in exporting, as regulators in attractive export destinations such as Europe and the US demand higher quality of medical devices entering the market.
Early-stage biotechnology companies will see benefits in venture capital but must first focus on due diligence.
Before seeking growth capital, biotechnology companies must first ensure that their ideas are protected and that they are able to conform to an increasingly complex regulatory environment.
Companies seeking to generate and protect intellectual property (IP) will see benefits in venture capital funding over public sources that can limit a company’s usage and ownership rights, and venture capital advisers will continue to provide invaluable guidance at both the product development and exit stage.
Digital health will present opportunities for start-ups, but big data and closer relationships with customers will lead to compliance issues.
Small to medium-sized enterprises (SMEs) will have an edge over big companies in the development of mobile and digital health products, as they continue to be more agile in the innovation process and remain unhindered by stringent governance processes. However, these companies have the potential to grow rapidly, and need to be aware of the compliance issues that surround closer customer interaction and the use of big data.
Pharmaceutical companies see challenges in R&D funding, emerging markets and industry collaboration.
Demanding investors and enhanced efficiency in spending will make the research and development (R&D) process more challenging for pharmaceutical companies in the next 12 months. Meanwhile, rapid expansion into emerging markets will be fraught with legal hurdles.
Pharmaceutical companies will be challenged to expand into regions without proper market access or experience and are likely to experience difficulties, particularly around regulation and corruption. Anti-trust will continue to be a key issue for pharmaceuticals, as the supply chain becomes increasingly collaborative.