SMEs face a number of specific challenges during development and prior to approval and commercialisation, operating under tight financial constraints and with limited human resources. Under these specific constraints, being able to afford the appropriate expertise and to meet additional requirements to fulfil HTA obligations can be an issue. The results from responding SMEs indicate that the general knowledge of HTA requirements and processes is poor among biotech SMEs. Very few companies reported that HTA has had any impact on their clinical trial design or other key decisions during the development stage. The survey also points to a worrying lack of communication between SMEs and HTA authorities.
"There is anecdotal information that SMEs are struggling with HTA." explains Thomas Bols, Chair of EuropaBio's Healthcare Council "To address this situation, we needed facts about the nature and extent of the problem. Information from HTA, such as clinical effectiveness and cost effectiveness, is increasingly required by authorities to take decisions on pricing and reimbursement, and allocation of healthcare funding."
"The low awareness of HTA among biotech SMEs and, as a consequence, the struggle to demonstrate the value of their products, can be a serious problem. If biotech SMEs cannot gain funding, their product may never reach patients, who in turn may miss out on new treatments that could greatly improve their lives" commented Bols. "This issue is an important one, which EuropaBio will want to address in European fora which discuss HTA issues, such as EUnetHTA project."
"Most biotech SMEs are drug developers, but currently, all do not possess the expertise to market these products in the face of rigorous demands of HTA. What is needed is a shift in the mind-set of both HTA authorities and SMEs alike which recognises that gathering information for HTA is a shared responsibility. Importantly, we need to see what the EU and HTA bodies, and the biotech industry itself, can do to better support SMEs during this process." said Anna Hallersten, Public Affairs Director at SFL.
The results of this survey will be presented on 27 March at the Drug Information Association's (DIA) 24th Annual EuroMeeting in Copenhagen, Denmark. The survey report is available online.
For further information, please visit www.europabio.org and www.sfl-services.com.
About SFL Regulatory Affairs & Scientific Communication Ltd
SFL Regulatory Affairs & Scientific Communication Ltd (SFL) is a consulting company based in Basel, Switzerland. SFL provides strategic advice and expertise to the pharma- and biotech sector in the areas of Regulatory Affairs, Public Affairs, Legal Services and Medical Communication, and is a member of EuropaBio.
About EuropaBio
EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 54 corporate members, 6 associate members, 2 BioRegions and 18 National Biotechnology Associations representing some 1800 small and medium sized enterprises.