Preparation is key to a successful working relationship with a pharma company. Emma Wilkinson shares top tips from the experts
Dr James Kingsland
(JK) NAPC president and national PBC clinical network lead
Dr Johnny Marshall
(JM) NAPC chair
(SM) Independent PBC consultant
(MD) Medicolegal adviser at the MDU
1 Be realistic
JK A collaboration that is about product focus and incentives is a thing of the past. Pharmaceutical companies are now looking to raise their profile through improving healthcare. I know it sounds very altruistic and I couldn't tell you how the business case works on the pharma companies' side of the table, but the shift has definitely moved from product focus to health outcomes. Obviously the companies will want to work in disease areas where they have products but they acknowledge clinicians want the freedom to use products from other manufacturers.
You still need to have accountability, though, particularly as such arrangements are going to be long term – working with you on a business case, helping redesign services, establishing outcomes. You're looking at a two-year association and over that time you will develop a relationship with that company.
2 Ensure accountability and get it in writing
JK There should be more accountability between practices and pharmaceutical companies. We have written agreements that describe the relationship so both parties know exactly why they are doing it. I'm not saying you have to get legal departments involved but we have put in place a contract of joint vision that includes what we're hoping to achieve and roles and responsibilities and who does what. It does need to be more sophisticated than just a standard supply of service contract.
JM It's important at the start that you have a formal agreement recognising what each party is going to put into the arrangement and what they are hoping to get out of it.
In terms of deciding which products to prescribe, this should be done before the arrangement begins or you need a governance arrangement to make sure drugs are given without any bias to a particular brand.
SM The biggest thing for me is to get an agreement so everybody knows what the project is all about, how it's going to be carried out, and who is responsible for what. You need absolute transparency, and you need to anticipate how you will audit and evaluate what is being done and who is in charge if things aren't going well.
You also need to consider time scale – length of the contract – and get that signed off by the pharmaceutical company, the PBC consortium and the PCT.
All too often you speak to people who say it's not going well and when you ask what was in their initial agreement they say they didn't have one. You have to get it down in black and white, including what outcomes they are expecting.
MD Doctors need to be very careful that data isn't extracted or used by the pharmaceutical company. If that is going to happen the rules on data protection, confidentiality and anonymity need to be followed.
GPs might also want to see the contract between the pharma company and any nurses it is funding who will be providing a service to their patients.
3 Think about HR
JM Certainly in my experience where pharmaceutical companies have provided nursing staff, if those staff move on, because of new jobs or maternity leave and so on, you need to make sure there's an arrangement for filling that space. It has to be done professionally.
JK It is important to remember you have to get any staff to sign data protection information and disclosures and conflict of interest and all sorts of simple documents – as you would if you were hiring any temporary staff.
4 Build on existing relationships
JK It is important to get on with the work and not spend hours debating what the relationship is, so it helps if you have a working relationship with the company already so you know how they operate.
My PBC group has three agreements at the moment – COPD with Boehringer Ingelheim and with GlaxoSmithKline, and one in stable angina with Servier.
The first two involve them supplying expert nurses who are shared among the 12 practices to run educational sessions with practice nurses, liaise with hospital consultants and see some patients in clinics. This is a time-limited scheme and will discontinue once the arrangement has achieved what it set out to do – get us to a certain level with COPD care.
Servier has supplied us with a health economist who works one day a week to analyse current disease burden and help us create a whole-system cardiology redesign. For Servier it is a way to build mature relationships and a opportunity to understand the NHS better. Short-term, product-focused initiatives are something the industry, the ABPI and the NHS are keen to see as the past and not the future.
All companies were already well-known to us and this meant that, when we started discussions about how these schemes would work, we were already on track about how a relationship would develop and what could be expected.
5 Know what you want
JM A collaboration works much better when the commissioner has identified which area they need support in. Then in the tendering process you can say: ‘This is where we need support. What can you offer us?'
The more it's done that way, the more it will meet the needs of the local community.
If you decide at the beginning what outcome you're looking for, you need to build into the contract how you are going to measure that and also how you will deliver that outcome. You can't wait until the end to decide how you will measure and demonstrate outcomes because that will never work.
6 Be transparent
MD You need transparency. So, for example, if nurses are provided through sponsorship, patients should be informed of that and doctors need to be absolutely clear that patients will be provided with the full range of care appropriate to their needs. And nurses shouldn't be there to put forward their own company's products but must provide advice that supports the whole range of products.
It creates fewer problems further down the line if patients know the situation from the outset.
Careful consideration needs to be given to confidentiality in all circumstances involving temporary staff so there needs to be a contract that defines confidentiality and patients need to be made aware of the arrangements.
7 Tell your PCT
JM The PCT may already have experience of partnership working and the agreements that have to be made, which may be useful. And to embark on such an arrangement may display you in a positive light.
We wanted to do some joint working with GSK on diabetes and when we checked the PCT already had guidelines on working with pharma companies, which we updated for PBC. We also made sure we understood what the PCT's position was.
MD It would be worthwhile letting the PCT know as soon as you are considering the plans, so that if they have any objections they can be addressed at the earliest opportunity. Medical defence organisations are also a good source of advice.
Emma Wilkinson is a freelance journalist
The legal bit
Mike Devlin, medicolegal adviser at the Medical Defence Union, goes through the rules you need to bear in mind
'There are various points of guidance that apply here. First, the GMC's Good Medical Practice says doctors must always act in the patient's best interests and must keep a record of inducements, gifts or hospitality. It says doctors should avoid conflict of interest – and not only an actual conflict, but also a ‘perceived' conflict. Perceived conflict of interest is a very important principle where doctors are going to accept sponsorship in any form.In addition to the core guidance, the GMC published supplementary guidance in 2008 that highlights the many ways that doctors may form relationships with the pharmaceutical industry. There are also statutory issues that doctors should bear in mind. For example, the medical advertising regulations from 1994 state that no person shall solicit or accept gifts and so on. We would say that GPs need to be extremely cautious about how they negotiate the sponsorship.Finally there's also the standard GMS or PMS contract, which describes obligations to keep a register of gifts. This register must be available to the PCT to view on request. Our view is that this ruling does not apply only to gifts from patients; pharmaceutical companies will also be caught by that definition and we would urge GPs to err on the side of caution and include any gifts on the register.