At the Pharma Outsourcing and Partnership Global Congress in London, Nazmin Pirmohamed, Director of Pharmaceutical Quality and Distribution at Biogen, told us Big Pharma’s “relationship advice” for outsourcing partners.
Pirmohamed told us with your partner, be it a contract research organization (CRO), manufacturer, or commercial service provider, the relationship should start with the long-term in sight – just like a marriage.
After problems with one of its patient-drug distribution partners in 2013, instead of dropping its relationship, Biogen instead invested into improving communications, deadlines for key performance indicators (KPIs), and committing to its partner’s recovery.
“You must agree when to communicate [with your outsourcing partner],” she said, and to aid this contractually with management involvement: “One of the principles of good distribution practice is management oversight.”
This is because “the contract back then didn’t dictate that [our partner] had to inform us of any service constraints,” she explained.
Significant Challenges
The contract being referred to was for a Home Care delivery service (HCS) of Biogen’s therapies, which appeals to many patients who would otherwise need to travel to outpatient pharmacies in hospitals to regularly collect their prescription.
For Pharma, to outsource this service also simplifies demand on in-house workload, Pirmohamed explained.
However, in the UK there have been significant challenges around the lack of regulation HCS has created, including issues with patient compliance, customer complaints, and one case described as “appalling” by patient groups.
The latter refers to a situation in 2013 when Medco Health Solutions Ltd, a major provider of HCS, unexpectedly pulled out of the UK market "overnight."
As a result, the firm’s 14,000 patients were redistributed between other providers, including Biogen’s partner Healthcare at Home Ltd (HaH). During this time many patients lost access to “essential medicines.”
Pirmohamed explained that the key failure here was that HaH was simply unable to cope with the delivery load and that the firm “took on too much business.”
This led to an investigation of Healthcare at Home by the Care Quality Commission, as patients were deprived of therapies for HIV, Multiple Sclerosis, and cancer.
Regulatory help
Obviously, to prevent the risk of such a situation happening again, regulators realized the HCS industry in the UK needed some guidelines and help in order to protect patients and ensure continuous access to medicines.
As such, standardization measures have since been drafted by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) and the Carter Review for the UK National Health Service.
“We can accept [HaH] was a victim of circumstance,” and “with these new measures, [HaH] addressed their failures, and has now recovered its ‘seal of approval’ from the Care Quality Commission.”