Fighting for Territory and Funding in Europe

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-07-01-2011, Volume 20, Issue 7

A newly released report has the pharma industry facing some new rivals.

"Failure to generate, support, and implement research means that patients are missing out on ground breaking new procedures and therapies." Does this sound familiar? And what about this? "There are challenges in designing appropriate trials and recruiting patients to them." Or this? "High quality research is essential for improving patient care and outcomes. Without the investment that enabled their development, the advances that benefit patients today would not have been possible. We cannot afford to discourage innovation."

Peter O’Donnell

Of course it all sounds like more of the same. This is the message that the European pharmaceutical industry has been delivering over and over again for years now, as it sees its research base threatened with erosion in the face of international competition and ever-tighter European drug pricing rules.

But this time it isn't the pharmaceutical industry. It is a rival for the sort of support that research-based drug manufacturers are constantly striving after. With only a few minor omissions, the extracts are taken word-for-word from a new report launched in mid-June by the United Kingdom's Royal College of Surgeons (RCS). The report constitutes an urgent plea for attention—and it cuts right across the ground that innovators in the world of medicines consider their own.

It complains, for instance, that in 2009 just 11 surgical trials were funded by the United Kingdom's principal health research bodies—"despite the fact," continues the RCS, "that one in four procedures in the national health service are surgical." By contrast, it says, there were more than 250 applications for Phase I trials for medicines and more than 800 approvals for post-Phase I trials. While the pharmaceutical sector spent more than $5 billion on research in the United Kingdom, currently only 1.5% of the $2 billion of annual UK government funding into medical research goes into surgical research, the surgeons lament: "Support for academic departments of surgery is declining as public and university funding is increasingly focused on other areas of biological science."

There is worse to come in terms of jockeying for position. "Surgery cures more cancers than any other form of intervention, including radiotherapy and chemotherapy," says the RCS. "Continued development and research into these types of curative treatments is vital." But lack of recognition "makes it difficult for surgery to compete for funding with other types of research."

A particular target of its attacks is "funding bias towards drug therapies" and "randomized clinical trials for drugs." The report recommends "a full review of public funding of translational research." One of the key concerns that the RCS sets out is that surgery is not incorporated sufficiently in the world of clinical trials. The sense of disappointment is articulated by Professor Martin Birchall, a UK consultant surgeon who is a pioneer of laryngeal and stem cell transplantation:

"For innovation to become a widespread part of new clinical practice," says Birchall, "effort, time, and cost needs to go into detailed laboratory work, meeting the public safety requirements, and finally performing often difficult clinical trials." And here things break down, he suggests. Moving into clinical trials "can seem so daunting that the amazing group of innovator-surgeons we are gifted with in the United Kingdom can often be discouraged from taking their ideas and science into the clinic."

By a curious coincidence, the RCS released its report on the same day that the European research-based pharmaceutical industry was holding its annual general meeting in Brussels. By something less of a coincidence, the principal declarations from the drug manufacturers were not dissimilar to those from the surgeons: most of the message can be summarized as "We are of vital importance, we are massively underestimated and undervalued by many healthcare authorities, and particularly victimized by myopia and short-termism among those responsible for healthcare budgets, who regretfully fail to see the broader picture and treat us as we deserve to be treated..."

By another curious coincidence, however, EFPIA—now under new management—is also talking of presenting itself as a partner in healthcare provision, of widening its own approach to the debate so as to take broader account of healthcare systems, of being cooperative and constructive, and of seeing the questions of drug provision from the point of view of the authorities and other healthcare players, rather than just through the perspective of the manufacturers. Now curious observers will have the opportunity to see whether the drug industry tries to meet the surgeons halfway—or whether each side will continue to fight its patch on its own terms.

New management

The new management at EFPIA, incidentally, is Richard Bergström, a Swede with a background in both regulation and the pharmaceutical industry, who has just taken over as director general. It is he who has been championing the "partnership" approach for the industry—he characterizes himself as a man of dialogue, keen to build trust.

He has wasted no time in trying to reinforce trust in some of the activities of the industry that have provoked controversy—and indeed vigorous criticism—in Europe. At his very first annual meeting of the organization he has just joined, he pushed through changes to the industry's codes of conduct on sampling and on company links to patient associations.

In eastern Europe in particular, the industry has been repeatedly challenged for its very liberal interpretation of what constitutes exceptional circumstances that justify sampling. Providing samples to healthcare professionals is, in principle, against the law in Europe—but there are exceptions. To familiarize doctors with new medicines, some limited sampling is countenanced. The industry has reached broad agreement that four small packs of a new medicine can be given to a doctor each year for two years, as long as the doctor makes a request in writing. Those two years have been stretching out rather longer in some of the EU's newer member states—those that came in from the cold after the fall of the Berlin Wall—and Bergström has persuaded the associations and companies that are EFPIA members to curb their enthusiasm for largesse.

Of more interest to clinical trialists are the updated provisions of the EFPIA code on contacts with patient associations. These groups frequently play an important role in highlighting rare diseases, in providing access to potential trial subjects, and in advocacy. Unsurprisingly, each company will have to make publicly available a list of patient organizations that it supports, financially or otherwise, starting next year. The list will have to permit "the average reader to form an understanding of the significance of the support," including "the monetary value of financial support and of invoiced costs," and the description must state the amount of funding and the purpose (such as an unrestricted grant, a specific meeting, or publication).

For "significant non-financial support that cannot be assigned a meaningful monetary value," such as the donation of public relations agencies' time and the nature of their involvement, companies must clearly describe the benefit that the patient organization receives. Companies must also ensure that their sponsorship is always clearly acknowledged and apparent from the outset.

EFPIA also introduced new rules on contracted services—which patient organizations increasingly provide as consultants to industry, including as experts and advisors for participation at advisory board meetings and speaker engagements. These rules require each company to make publicly available a list of patient organizations that it has engaged for such services, and the total amount paid per patient organization. Other limitations imposed are that contracts between companies and patient organizations under which they provide any type of services to companies are only allowed if such services are provided for the purpose of supporting healthcare or research. Compensation for services must be reasonable and "not exceed the fair market value of the services provided," and token consultancy arrangements may not be used to justify compensating patient organizations.

Elsewhere, the text recognizes that the industry "has many common interests with patient organizations, and expects that relationships take place in an ethical and transparent manner." The code also insists that "the independence of patient organizations, in terms of their political judgement, policies and activities, shall be assured." Pharmaceutical companies must not seek to influence the text of patient organization material they sponsor in a manner favorable to their own commercial interests.

The rules extend to events and hospitality involving patient associations. All events sponsored or organized by or on behalf of a company must be held in "appropriate locations and venues that are conducive to the main purpose of the event, avoiding those that are 'renowned' for their entertainment facilities or are 'extravagant.'" All forms of hospitality provided by the pharmaceutical industry to patient organizations and their members shall be reasonable in level and secondary to the main purpose of the event, whether the event is organized by the patient organization or the pharmaceutical industry. Hospitality extended in connection with events shall be limited to travel, meals, accommodation, and registration fees.

No free lunches, then. That is a lesson that the European pharmaceutical industry appears to be starting to learn, too. Bergström likes to say that if the industry wants to be treated as a partner, it must behave as a partner. It is going to have to abandon some of the presumptions that it has entertained over recent decades, which have deluded it into the belief that it is immune—and deserves to be immune—from public and economic pressures.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.