STEP-IN Management Ltd.
Continued from “Third parties“
First I want to separate out Joint Working from joint ventures. Both involve partnering with other organisations but the terms are sometimes used synonymously or grouped together which can be unhelpful.
A joint venture is a financially based business arrangement where “a third party provides a service on behalf of a number of pharmaceutical companies”. The pharmaceutical companies retain responsibility for approving activities including certifying materials.
Joint Working is also a business arrangement but the resource commitments and potential benefits are measured in terms wider than finance. A common opportunity for pharmaceutical companies to conduct Joint Working with the NHS has been where they can support (groups of) PCTs or Trusts to meet Government / NICE targets and consequently to benefit from associated funding, rewards and enhanced reputation as well as improved healthcare outcomes. The rationale for a pharmaceutical company is that a potential, parallel outcome will be the enlargement of the market in a particular therapeutic area i.e. not a bigger slice of the pie but the same proportion of a bigger pie.
From my experience, Joint Working brings similar challenges to those in joint ventures and also raises more which require interesting solutions in order to support to pharmaceutical Sales &, Marketing teams in getting it right.
“…Joint Working brings similar challenges to those in joint ventures…”
The NHS Constitution however allows for partnering widely and, in addition to the NHS, pharmaceutical companies might be jointly working with private health groups, IT companies, academic institutions and, indeed, competitors. Partnering could also involve other government agencies impacted by potential improvements to the delivery and administering of healthcare (such as alcoholism, mental health, substance misuse, access to contraception) e.g. social services, police, prison service, education. Charities also working in these areas could be partners. Finally third party service providers may be participating as partners or continuing to operate as service providers for one of the pharmaceutical companies which is where the blur with joint ventures can arise.
Instances of Joint Working are likely to increase. The NHS drivers are, not surprisingly, cost constraints and efficiency targets while striving to meet their patient needs and community health strategies. Specifically:
• Management, consultancy and other non-clinical resources in NHS operations are under scrutiny for costs savings, and so they will increasingly look outside for support in such activities as project management, capability assessment toolkits and software programs, staff development, economic and statistical analysis and building cases for funding bids, process analysis and improvement, new systems or process implementation, measurement and reporting, patient education.
• Meanwhile, the duty placed on commissioning consortia to reduce health inequalities has been confirmed by the NHS Future Forum “The Mandate for the NHS Commissioning Board, the outcomes frameworks for the NHS, public health and social care, commissioning plans and other system levers and incentives must all be used to help reduce health inequalities and improve the health of the most vulnerable. These now need to be translated into practical action.” Joint Working could well provide that practical action.
So what are the compliance challenges? I think these fall into two groups: 1) practical issues in planning and managing a Joint Working project and 2) ensuring appropriate placement of Joint Working in a marketing strategy, including positioning compliance in a long-term business plan in which Joint Working is only a stage or one element.
“Sales representatives should not be made to look foolish and unaware of a Joint Working project”
This is when a brand or therapeutic team see an opportunity for Joint Working and need to think through plans with potential partners and factor in compliance. The majority of issues are covered in ABPI Guidance i.e. resources and contribution, transparency, data privacy, patient confidentiality, governance, articulating mutual benefits and ROI, measuring outcomes, agreements and exit plans, communications internally and externally, using data collected, commercial confidentiality.
In my experience additional care is needed in addressing the following:
• Internal communication to the sales force that a Joint Working project is in place. Sales representatives should not be made to look foolish and unaware of a Joint Working project when their GPs are. Providing sufficient information such that they are aware while excluding the project from sales discussions needs careful timing and wording
• Managers responsible for marketeers involved in a Joint Working project and also Sales colleagues for brands in the same therapeutic area need guidance and support about how to manage effectively while separating their knowledge
• What seniority of person should be on the Joint Working Committee? How does escalation within one party play out in the Joint Working arena without triggering unnecessary exits?
• Where parties have similar procedures and activities, whose processes ‘trump’. This is key to prevent multiple parallel (or worse, sequential), slightly different processes for approving materials. What happens if parties disagree and some approve and some don’t?
• Documentation: who holds the master set of records? How are documents shared? What is the retention period? Who approves deletion when the time comes?
• Does the project need a single data controller who will address data privacy breaches and liaise with the Information Commission, if necessary?
• Where one party is a patient group charity, how will the project best go about keeping an appropriate space between the pharmaceutical companies involved and the patients represented by the patient group?
“What happens if parties disagree and some approve and some don’t?”
Marketing strategy issues
1. The difference between Medical and / or educational goods and /or services (MEGS) are set out in the ABPI Guidance. The value of an activity delivered as a Service to Medicine (StM) and its potential for a Joint Working project often only becomes clear, however, after the StM is complete (ROI is only allowed post StM). But how does a brand move an activity initially delivered as a Service to Medicine (i.e. free to the NHS recipient) to Joint Working status? In practice separate StMs will be in place concurrently but with differing start and finish times so the same activity may be planned for delivery as both StM to some PCTs, for example, and as Joint Working to other PCTs at the same time. This is both a business compliance issue for the company concerned but also an industry reputation issue.
What is needed is unambiguous criteria regarding which PCTs or other NHS groups qualify for StM e.g. identified areas of deprivation using government statistics. Although a pharmaceutical company will post its ongoing StM and Joint Working projects, between them these will not explain the rationale. The marketing team must articulate and document the thinking and criteria behind its decisions and apply them consistently.
2. Where partners are not the traditional ones e.g. prison service, the expertise of the pharmaceutical company personnel may well spot opportunities beyond the health ones initially on the table. Financial and statistical analysis, budget bidding, process improvement, for example, are skills valuable in a wide spectrum and opportunities to deploy them beyond the Joint Working project remit and traditional pharmaceutical arena may arise. How can parallel non-health related business arrangements operate appropriately? This would be a completely commercial activity not governed by ABPI or similar code.
3. As such activities outlined in #2 grow is the business really pharmaceutical? Does, in fact, a separate commercial arm need to be established and how does the company spot when it is at this stage?
I told you Joint Working was interesting. And if anyone needed convincing, these questions truly demonstrate why the Compliance function needs to be part of the business and not a Code quoting add-on.
The next article in this series can be viewed here.
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About the author
Jean has worked in the pharmaceutical industry for over 20 years, and is currently an interim manager addressing business compliance and records management with a special interest in e-marketing, Joint Working and the UK Bribery Act.
Former positions include Compliance Director for Schering Plough UK and Head of Clinical Programming and Medical Writing at Pfizer’s UK R&,D. In previous roles Jean had responsibility for the development of GCP SOPs, Training and Clinical Trial process improvement, was Inspection Readiness lead during an MHRA inspection and was part of an EFPIA Task Force addressing the secondary use of Electronic Health Records for clinical trials and the privacy and data standards issues this concept raises.
What do you think is the biggest challenge to joint working?