Referral Management Service
When this generic international pharmaceutical company found its promising pan-European license application suddenly encountering an unexpected problem, it turned to ELC to navigate the complex referral process and get back on track to achieve the all-important approvals it needed to go to market.
Part way through a 200 day procedure to license its medicinal product in 30 European countries, this pharmaceutical company found itself facing a potential license suspension thanks to a health concern raised by assessors at a single EU agency. The procedure was one day away from a successful closure.
Failure to achieve a license would represent the loss of 18 months’ time and thousands of dollars of investment to bring the product to market in Europe. Even in the event the license proceeded successfully, the referral process itself risked a potential delay of up to 80 days which would seriously impact the company’s credibility with its local distribution partners and represent significant cost to all concerned.
With a major EU referral meeting on the horizon the pharmaceutical company needed to respond fast, and turned to ELC Group to help.
ELC Group solution
ELC Group was able to instantly respond and in a matter of days had communicated with assessors in all EU agencies concerned in a bid to uncover the true issue. Alongside preparing for the all-important EU referral meeting, ELC Group’s crisis management team actively managed the expectations and needs of the pharmaceutical company’s extensive European partner network.
ELC Group reviewed all submission materials and was able to confirm quickly that the documentation was robust. With this established, ELG Group next drew on its extensive network of experts – many of whom have previously worked as assessors in the EU agencies involved – to reach out to the regulatory bodies and, using its extensive networking contacts, establish the exact grounds for the referral decision.
- Within just 5 days ELC Group’s technical and regulatory experts had completed its exploratory discussions with assessors at all agencies involved to establish their interpretation of the situation. After reviewing this information, ELC Group was able to identify that a simple failure to communicate some key data in a certain way had led to assessors at one agency raising concerns about a potential public health issue.
- Armed with this information, ELC Group was able to talk to the pharmaceutical company’s experts and establish a way to express the data in a manner that would meet the requirements of all EU assessors. ELC Group’s close alliances with the relevant experts helped to speed and ease this process significantly.
- In parallel to managing activities with the regulatory bodies, ELC Group also initiated crisis communications with the pharmaceutical company’s European distribution partners, providing daily updates on timelines and fielding questions relating to the realities of the product safety implications of the high potency generic medicine.
- ELC Group negotiated an early off-line meeting with EU assessors and attended the EU referral meeting on behalf of the pharmaceutical company, presenting the key data and fielding responses. The referral was dismissed, the submission was successful and a license was conferred.
- ELC Group was able to respond at speed, gleaning detailed information on the realities of the concerns raised and gaining a unique insider perspective on the assessors’ viewpoint. It took just 5 days to assemble this data and formulate a response.
- The pharmaceutical company was able to rely on ELC Group’s local experts to represent its interests with EU agencies and prepare its own non-European based team of experts for how best to respond.
- Delay to licensing was significantly minimised, despite having to undergo a referral meeting. The company achieved a license close to the expiry of an existing patent and was the first to go to market in Europe with a generic equivalent product.
- With limited resources in Europe, the crisis communications program undertaken by ELC Group with key European partners meant the pharmaceutical company was able to maintain excellent relations with partners and ensure distribution structures were still in place when license status was ultimately achieved.