Regulators are increasingly scrutinising early access to medicines and considering (see the draft Cures Act in the US) mandating companies to make their access policies public. Recent research1 has shown that 52 percent of the top 25 companies by market cap disclosed policies on their websites. By contrast, 14 percent of medium-sized companies posted details and only 4 percent of smaller companies, with market caps of less than $1.5 billion, did the same. A subsequent online poll2 showed that companies agree that publishing a compassionate/early access policy should be made public on their website.
I fully agree that a public policy is a step forward in enhancing transparency and I also expect that in the next five years’ all companies will have one. However, it is important to note that a company can only fulfil its public commitment if they have developed a clear and well-implemented internal strategy.
What do I mean by that?
It is important to have a centralised decision-making process as this is the only way to ensure consistency and fairness. By consistency I mean, for example, that the criteria for the provision of access to a medicine should not vary amongst countries. By fairness, that there is a clear process so that favouritism is not possible.
Once you have decided to provide access, this needs to happen quickly as often patients cannot wait for a convoluted internal corporate process to take place.
We have seen a big change in this space and we know that you will receive requests for access if your medicine shows promise. You have the choice of being reactive or to plan proactively. You can prepare by having clear decision points embedded in the lifecycle of your product and agreed parameters to use as a rationale for decision-making.
Only by having a clearly defined internal strategy the patient’s right to access a medicine can be fulfilled.
To learn more about how to develop a transparent and consistent corporate policy for early patient access, please register for our upcoming webinar.
1 Brenda Huneycutt, Nina Mermelstein, and Gillian Woollett White Paper Avalere Health 10 October 2016 Current State of Transparency of Manufacturer’s Compassionate Use Policies