The BIA has eight established advisory committees who deal with a range of topics, from regenerative medicine to finance and tax. Meeting once a quarter, the committees are crucial mechanisms to highlight and explore key issues facing bioscience companies. Committee members include influential experts from across the sector. Their work informs and guides BIA policy and priorities, ensuring that member needs are met. 

This week we have updates on the activities of the Regulatory Affairs Advisory Committee and the Intellectual Property  Advisory Committee.

Regulatory Affairs Advisory Committee (RAAC)

Throughout this year, RAAC has continued to build upon a positive working relationship with the Medicines and Healthcare Regulatory Agency (MHRA) and the European Medicines Authority (EMA). This has included collaborating on a number of successful events, for example the popular joint conference with MHRA in June on the opportunities and challenges in the regulation of healthcare innovation to stimulate innovation and accelerate patient access, which attracted over 130 delegates.

One upcoming event to note is the BIA Regulatory Dinner Discussion – Healthcare innovation and regulatory decision-making in the biocentury – with guest speaker Dr Ian Hudson on 22 October 2014. Dr Hudson will reflect on his first year as MHRA’s Chief Executive, supporting innovation as well as the challenges of regulation in the current environment.

The committee continues to advocate for a supportive environment for clinical research and innovation. Earlier in the year BIA produced a briefing paper on the new EU Clinical Trials Regulation, which explains the major changes brought in by the new legislation and provides some practical considerations until the Regulation is implemented. The BIA, together with EuropaBio, is taking an active role in influencing the development and design of the EU clinical trial portal and database. The committee has also been closely involved with the clinical trials transparency debate and contributed in May to the EMA’s targeted discussions with key stakeholders.

Collaboration with sister organisations has also been an important area in 2014. Back in June, BIA teamed up with the Association of the British Pharmaceutical Industry (ABPI) and the Centre for the Advancement of Sustainable Medical Innovation (CASMI) to host a one-stop-shop event on the EMA’s adaptive licensing pilot project – you can read a write-up of the event here. In another joint effort with ABPI, BIA also developed communication materials on biological medicines, including biosimilars, to enhance prescribers’ and other stakeholders’ understanding of these medicines.

Intellectual Property Advisory Committee (IPAC)

This year IPAC has continued its focus on issues relating to intellectual property in the biotech sector. Ongoing discussion topics have included the implementation of the European regulation arising from the Nagoya Protocol on Access and Benefit Sharing, and the question of grace periods (the period of time within which, if an invention is disclosed to the public, it can still be the subject of a patent application). Grace periods exist in the US and Japan and there appears to be a move in various quarters, particularly arising from discussion on harmonisation, to consider bringing in grace periods in Europe where they do not currently exist.

IPAC provided comments and draft wording in relation to the Bolar Exemption in the Legislative Reform (Patents) Order 2014. Following on from last year’s introductory and update blogs on Supplementary Protection Certificates (SPCs), IPAC has continued its regular review of SPC legal cases and reviewed the Law Commission report regarding groundless threats.

Through regular bilateral meetings with the government’s Intellectual Property Office (IPO), IPAC remain updated on various issues including progress on the establishment of the Unitary Patent Court. Earlier this year IPAC members also met with the Minister for IP for a discussion to highlight the relevance of IP to the biotech sector.

For the remainder of 2014, IPAC’s priorities will continue to reflect some of these major issues. The Unitary Patent and the Unified Patent Court will remain a significant area for monitoring and input, and a close watch will be kept on the possibility of grace periods being introduced in Europe so that appropriate advice can be given to BIA members on how it might affect them. The Committee will also be keeping a watching brief on developments relating to recent US Supreme Court decisions regarding what is considered patentable subject matter – and subsequent USPTO guidance. The implementation of the Nagoya Protocol will be kept under review, taking action as and when appropriate to strive for proportionate enforcement and keeping adverse impact on patenting to a minimum

IPAC and RAAC are also considering areas of common interest where they might work together, such as exploring the regulatory and intellectual property aspects of personalised medicines.