HEALTHCARE AND LIFE SCIENCES DISPUTES, REGULATORY,
COMPLIANCE AND INVESTIGATIONS
UNIQUE CHALLENGES OF
INTERNATIONAL PATIENT
SUPPORT PROGRAMMES
CHALLENGE #1:
DIRECT-TO-CONSUMER COMMUNICATION
In most countries outside the United States (U.S.), advertising and promotion of
prescription-only medicines to the general public is strictly prohibited, causing a
struggle to reach patients with life-threatening diseases who could benefit from
information about, and ultimately access to, new medicines.
According to Nicola Bedlington, Executive Director of the European Patients’ Forum
and coordinator of the European Academy on Therapeutic Innovation (EUPATI),
“Everybody recognises that there are many unmet needs for most patients with
life-threatening diseases. Patients know their needs best but rarely have the broad
know-how on how the highly regulated and complex R&D process works.”1 To meet
these needs, many manufacturers are creating patient assistance programmes (more
commonly referred to internationally as patient support programmes [PSPs]).
“Everybody recognises that there are many unmet
needs for most patients with life-threatening diseases.
Patients know their needs best but rarely have the
broad know-how on how the highly regulated and
complex R&D process works.”
/ NICOLA BEDLINGTON, EXECUTIVE DIRECTOR OF THE EUROPEAN
PATIENTS’ FORUM AND COORDINATOR OF EUPATI
CHALLENGE #2:
SAFETY DATA MANAGEMENT
There are fundamental differences in the structure of patient
support programmes outside the US due to the directto-consumer communication and advertising prohibition.
Manufacturers are beginning to design these support
During PSP communications between patients and
programmes to help patients and healthcare professionals
manufacturers or third-party agents, patients could describe
better manage disease and optimise treatment.2
possible adverse events (AEs), including serious adverse events
(SAEs). Clear written instructions and training on how to
WHAT EXACTLY IS A PATIENT
SUPPORT PROGRAMME?
identify an AE/SAE and how to report it are critical, as there are
According to the Association of the British Pharmaceutical
can be severely penalized if reporting is delayed for any reason.
strict requirements for manufactures to promptly report out all
AEs and SAEs. The key word here is promptly—manufacturers
Industry (ABPI), a PSP is defined as a service for direct
STEPS TO PSP COMPLIANCE
patient or patient caregiver interaction designed to help
the management of a medication or disease outcomes (e.g.,
In light of established policies, the first step to ensure
awareness, education, adherence) or to provide healthcare
programme compliance while addressing market access to your
professionals with support for their patients.2
products is to review your organisation’s patient programmes.
In most European Union (E.U.) member countries subject to
E.U. privacy directives, patients are required to provide consent
What should you be assessing?
to be contacted directly prior to enrolling in a PSP. Often the
•• Program structure: How is the programme structured?
patient and/or caregiver is informed about the programme
Which internal departments are managing the programme
when the medication is prescribed. Program enrollment and
or its vendors? How do you ensure your programme is
access to its services are predicated upon prescription.
compliant with the policies limiting direct-to-consumer
Under ABPI guidance, PSPs typically include the following:
communication?
•• Privacy safeguards: What safeguards do you have in place to
•• Compliance/adherence programme: Patients are contacted
protect patient privacy?
to see how they are managing their medication.
•• Distance maintenance: Do you engage a third party to ensure
•• Call center: Patients and/or caregivers can contact the
that you are not perceived as practicing medicine? To ensure
manufacturer to get additional information about the
you are not paying state employees for nurse educator
medication or the disease for which it was prescribed.
services?
•• “Nurse educator” programme: The manufacturer hires
•• Safety data collection: Have you structured your programme
independent, third-party nurses to interact directly with
with appropriate requirements to gather adverse event and
patients to help them properly administer their medication or
safety data?
manage their disease.
•• Procedures and business processes: Do you have written
Other countries or trade associations may also permit financial
procedures and processes in place to develop and implement
assistance for patients who cannot afford their medication.
a monitoring programme to provide visibility into these
activities’ management and compliance?
2
THE FUTURE OF PSP POLICY MAKING
Pharmaceutical companies and patient organisations may have
very different origins, but they do share common interests,
particularly in many E.U. policies. Patient organisations have a
unique expertise on the challenges of living with a particular
illness, which is a powerful message to share with policy makers.
The Innovative Medicines Initiative (IMI), Europe’s largest
public-private partnership, was created to speed up the
development of better and safer medicines for patients,
particularly in areas where there is an unmet medical or social
need. By facilitating collaboration among the key players (e.g.,
researchers, life sciences companies, small and medium-sized
enterprises, patient organisations, regulators), IMI aims to
improve the current drug development process, reduce the time
to reach clinical proof of concept in medicine development, and
increase the success rate in clinical trials of priority medicines
identified by the World Health Organisation.3
The European Federation of Pharmaceutical Industries and
Associations (EFPIA) has gone so far as to develope a Code of
Practice on relationships between manufacturers and patient
organizations to ensure that these relationships are both ethical
and transparent.4 Additionally, European patient organisations
and the EFPIA have agreed to work together, within a “Patient
Think Tank,” to open two-way discussions and information
sharing, increase mutual understanding of each other’s position,
and understand respective concerns over E.U. policy, strategies,
and goals.5
ENDNOTES
1.
European Federation of Pharmaceutical Industries and Associations (EFPIA),
“Relationship with Patient Groups—Making Sure We Hear Them Loud and Clear,
EFPIA website. Accessed August 9, 2016.
2. The ABPI Pharmacovigilance Expert Network, “Guidance Notes for Patient Safety
and Pharmacovigilance in Patient Support Programmes,” Association of the
British Pharmaceutical Industry, May 9, 2011.
3. Innovative Medicines Initiative website. Accessed September 9, 2016.
4. EFPIA, “EFPIA Code of Practice on Relationships between Pharmaceutical
Industry and
Patient Organisations,” Amended June 14, 2011.
5. EFPIA, “Patient Think Tank,” EFPIA website. Accessed September 8, 2016.
3
CONTACTS
CHRIS J HOLMES
Director
[email protected]
+44 (0) 20 7015 2389
ANN BEASLEY
Director
[email protected]
+1 617.748.8347
ALEXANDROS CHARITOU
Associate Director
[email protected]
+44 (0) 20 7015 2319
TIDO EGER
Associate Director
[email protected]
+44 (0) 20 7015 8838
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