Market access still a slow process
Nordic Pharma started with its main focus on the hospital market and its biggest business is with gynecology. But in 2007
it successfully launched Metroject, tapping into the rheumatology market, which was new to the company. "Getting the reimbursement
of Metroject was a challenge," Rebours-Mory remembers. "But we were quite happy to get reimbursement at a reasonable price,
because we are bringing an important novelty to patients".
Refundable drug regulatory circuit
Despite its core focus on innovation, the system's major drawback might be timing. "The process takes six to seven months
which can be perceived as a long time to market. As a result, the first patient may not have it as quickly as in the UK or
the US," acknowledges Renaudin. "We don't want drugs to come to market quicker. In France, for the most innovative drugs there
is a Temporary Authorised Use (ATU) system which allows for the use of these drugs in hospitals even before registration and
is free to the developer of the drug. Thus, all the new drugs and technology are available in hospitals. On the other hand,
we are of the opinion that it is worth the assessment time before outpatient use. This allows for an examination into whether
it deserves an innovative price or not," he explains.
For Olivier Daubry, general manager of Celgene France, the ATU is one of the best examples worldwide of early access to innovation,
allowing patients to quickly receive innovative drugs for life-threatening diseases with high unmet medical needs. This was
the case of Revlimid, which obtained a market authorization in France in June 2007 as a treatment for patients with multiple
myeloma after prior therapy. It is now a leading therapy for this indication in France, and the #1 brand worldwide.
Hence the French system seems to fit perfectly with Celgene's overall strategy. "What we try to do at Celgene is to deliver
absolute breakthrough innovative medicines. If we understand a project does not bring a significant clinical benefit that
dramatically changes people's lives, we drop it," he says.
Celgene also benefitted from a system with Thalidomide, which for several years was available through the ATU process to patients
in first line myeloma for elderly patients but also other rare diseases where patients are desperate to have an effective
treatment. Thalidomide was eventually officially accessible to outpatients in October 2009, but within a very strict safety
"For life-threatening diseases with high unmet medical needs and where patients have used all registered drugs the ATU system
allows innovative drugs to be administered in a very controlled process before registration. It is a positive example for
early access to innovation," says Daubry.
"France has a very good system in terms of access to market compared to many other countries so fundamentally, the system
of assessing innovation is good. If we take an example in oncology, a study done by a Swedish team last year shows France
at the head of Europe in terms of speed to market," concurs Hervé Gisserot, head of GlaxoSmithKline France. With investments
reaching €850 million ($1.2 billion) in the past three years, GSK is the largest foreign investor in the sector.
"Instead of complaining, the health community has to work together to clearly define what we consider to be innovation. For
instance, when it comes to clinical trials we should work not only with clinicians but with regulators and payers, in order
to ensure that the design of our clinical trials and the profile of our drugs meet the answers to their questions. In the
past getting an approval for your drug was sufficient because access to market was relatively easy so the entire process was
focused at getting approval. Now, at the very least, you have to focus on getting access which is why within GSK we have taken
to specifically developing a reimbursement file for a drug to make sure it meets these further requirements. In our industry,
getting approval without access is basically like getting nothing at all", Gisserot concludes.