The Fine Line of Pharma & Patient Group Collaboration

A new attempt by European drug firms and patient organizations to chart a course between cooperation and cooption has highlighted the scale of the challenges that healthcare stakeholders face when they reach out to one another. “Any relationship between patient organizations and the pharmaceutical industry can be perceived as commercially motivated,” concluded this exercise, conducted over recent months by the biggest European players on each side: the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Patients’ Forum (EPF).

The paper they have produced, “Working together with patient groups,” is couched in carefully controlled and diplomatically sanitized language, as is to be expected from two such sophisticated organizations, and it aims to present a practical and constructive take. But its proposed solutions are, nonetheless, tantamount to a recognition that the challenges it identifies are far from being met-patient groups still labor under the shadow of accusations of behaving as the drug industry’s hired lap-dogs, and drug firms continue to be suspected of manipulating patient organizations like glove puppets, simply by scattering a few crumbs of their profits among them.

Continuing financial dependency “may lead some to assume there is undue or inappropriate influence of the industry on patient organizations and their decision-making,” acknowledge EFPIA and EPF. The possible remedies run the familiar gamut of keeping everything clean and above board, ensuring collaborations aim at “clearly identified patient benefit,” observing good governance principles and codes, communicating transparently and “proactively and publicly,” and fuller disclosure of funding links.

Relationship gains

There is much that can usefully come out of cooperation, they say. Patient organizations may collaborate with industry to co-create educational programs and take part in clinical development through working with regulatory authorities, ethics committees, investigators, and industry, or contributing to study design and the development of layperson summaries, or even provide input into recruitment and retention. Patients can provide researchers with insights into the challenges of living with a disease, enabling drug manufacturers to incorporate feedback directly into their R&D processes; and they play an increasing role in regulatory processes, and even in defining the value of medicines.

But the overall tone is defensive. “Collaboration between pharmaceutical companies and patient organizations fulfill a legitimate need for interactions identified in advance,” the two groups say, subject to some of the reservations and conditions about “how these relationships are managed.” They are at pains to underline the need for independence of patient organizations “in all aspects of their decision-making, development of policies, and external communications” to ensure credibility. But the overall impression from the conclusions is that despite all the efforts to dispel doubters’ concerns, both sides are resigned, at least for the present, to being on the receiving end of persistent skepticism.

Paradoxically, closer collaboration between health stakeholders is these days being driven by a growing chorus of calls to bring coherence and new efficiencies to Europe’s fragmented health systems. EFPIA and EPF themselves note that in the past, industry, academia, healthcare professionals, regulators, and patient organizations “largely worked in silos.” Decisions about patients’ care, medical research, health information, and service design “were taken without meaningful patient involvement,” leading, they say, “to inefficiencies and low value in process and outcomes.” Nowadays, companies have developed new ways “to incorporate patient insights and to collaborate with patients and patient organizations in a transparent and ethical way,” resulting in “better trials, better engagement, better communication throughout the entire life cycle of medicines-and ultimately better patient outcomes.”

Ties questioned

But the shadows of suspicion are hard to dispel. It isn’t just in the area of drug firms’ direct funding of patient organizations that the attempt to hold hands but to stay at arm’s length runs into trouble. A major project to train betterinformed patient advocates over the last three years, known as the European Patients Academy, and drawing on patient organizations, academics, and regulatory authorities, was repeatedly accused of playing an industry game because part of its support came-in kind-from drug companies.

At the same time, on everything from drug pricing to drug research, and from cross-border care to assessing the performance of national health systems, the slogan is “work together.” Just before the summer, more than 100 European health organizations wrote an open letter to the European Commission insisting that “EU health collaboration is crucial for Europe’s future,” and demanding that “voices from civil society-patients, consumers, health professionals, epidemiologists, and technical experts-are represented in policy dialogues that build on all available evidence and expertise.” In October, a key recommendation from an EU panel of experts on developing new pricing models for innovative drugs was to “create dialogue platforms involving all relevant stakeholders.”

The obvious impediment to this vision of utopian harmony among stakeholders is that not every stakeholder shares the view of the others. As George Bernard Shaw sagely advised: “Do not treat everyone as you would treat yourself. Their tastes may not be the same.” So a warning bell immediately starts to ring when, for instance, a new report from the EU on its exploration of best practice in national health systems remarks that health service performance assessment “is a complex combination of activities” that includes at the top of its priorities “the involvement of stakeholders,” and that sees a role for providing citizens “with the information of what they can and should expect from the health system.” It envisions the collection and dissemination of information on the functioning of the health system as “a key element allowing patients to use broader knowledge for more educated choices.” That, of course, depends on what is considered an “educated” choice-and raises the slightly chilling prospect of the Goliath of health systems deciding for each David what his or her educated choice should be, or of neutered patients compliantly abdicating all responsibility for their own decisions.

Conflict awareness

A degree of distrust is not only to be expected, it may be valuable in moving toward real rather than apparent solutions. Distrust featured prominently in the input from some civil society contributions to the EU debate on how to promote closer collaboration on health technology assessment (HTA) earlier this year. The European consumers association, BEUC, for instance, while in principle in favor of taking EU-level cooperation further among national HTA authorities to bring greater coherence to EU medicines provision, highlighted the risks of

industry gaining undue leverage without tight safeguards. “The interests of industry and HTA can differ,” it said in its response to the EU consultation on the future of HTA. Even if early dialogues among industry, drug regulators, and HTA organizations “can be beneficial,” it is essential to take into account “the conflict of interest that might arise.”

Similar warnings came from Prescrire, the non-profit group of health professionals that publishes independent information on drugs and therapeutic strategies. Prescrire flatly rejected the merits of early dialogue, which it sees as a backdoor allowing industry to stitch up drug pricing deals instead of presenting objective arguments for a drug’s merits. It said that allowing industry access to early dialogues provides them with “a platform that can lead to regulatory capture and enable companies to influence pricing and reimbursement decisions.”

Careful consideraton

At a time when the pressure for collaboration and cooperation is increasingly strong-take, for instance, the gathering momentum of personalized medicine, or the influence of the so-called “roundtables” organized by leading drug firms and national health authorities in Europe over the last year, or the countless “joint actions” under the EU’s health program, or the burgeoning public-private partnership of the Innovative Medicines Initiative-it may be time to pause and reflect for a moment on whether all forms of collaboration are as good as they purport to be, and whether everyone swept up in the headlong rush to join is going to benefit equally.

Reflector is Pharmaceutical Executive’s correspondent in Brussels