Productive Partnerships: European Treatment Activism
Europeans have long looked at US AIDS activism with a mixture of awe and concern. Awe at its power to move the agenda forward, and concern at its introspective focus. As with so many features of US life, it is introspective because America is self-contained in its splendid isolation, while Europeans are becoming increasingly used to seeing their lives in a multinational context.
Public debate in Europe is currently dominated by one topic: closer economic and political union. The European Union will grow northward and eastward to embrace Scandinavia, the Baltic states, and central eastern Europe during the next ten years. How can Europeans reconcile the seemingly autonomous dynamic of globalization and commercial harmonization with the increasing diversification of Europe? Are we heading for a United States of Europe, as English statesmen fear and German leaders appear to desire fervently, or another Holy Roman Empire, its lingua franca English and its governance a patchwork of states with many proud histories and many conflicting customs, held together only by fear of invasion from outside?
Across the EU
Bringing together European activists in the field of AIDS has been a slow process, but the growing realization that Europe is becoming an interdependent web is forcing activists to move quickly to develop a pan-European perspective. The shift to a pan-European drug approval process and the tendency of companies to conduct compassionate release operations at a European level has led to closer contact among treatment advocates across the European Union, primarily through the vehicle of the European AIDS Treatment Group (EATG).
Following criticisms that the Second International Congress on Drug Therapy in HIV Infection (Glasgow, 1994) lacked community input, chairman Professor Ian Weller was eager to ensure that European activists got the chance to participate in the Third Congress in Birmingham, and to hold a satellite meeting. The result was a session entitled "Productive Partnerships," intended to highlight the ways in which European activists have worked with clinicians, researchers, regulators, and public health officials in the European Union countries.
The European AIDS Treatment Group was founded in 1991, and now comprises over 60 activists from 17 European countries. France, Germany, and the UK are most heavily represented in the group, but one of the group's priorities for 1997 is the development of treatment activists in Spain, Portugal, Italy, and Greece, and a southern European activist training is planned for April in Naples.
The group's current focus is shortening the gap between scientific approval and marketing approval in the European Union's drug licensing procedure. The group also wants to see clearer drug approval guidelines in Europe, says executive director Arjen Broekhuizen, a political journalist from The Netherlands. "At the moment it is unclear to everyone -- industry, regulators and the community -- what requirements a company has to meet in order to get approval."
At a European level, activists are working hard to form strategies for developing trials. Raffi Babakhanian of the UK-based AIDS Treatment Project (ATP) reported on the EATG's progress in bringing together researchers, industry, and regulators to discuss whether they could cooperate in the development of strategy trials. He noted that as "honest brokers" activists are well placed to bring together the interested parties, as ATP and EATG did at a meeting in London last June. The groups intend to organize a similar meeting during 1997 and hope to work closely with the Keystone Group in the US on the international coordination of strategic research in HIV drug therapy.
A European minimum standard of care is another focus, and the group plans to lobby at the national and European Union levels with governments, professional associations, and doctors to win agreement on a common standard for HIV care throughout the EU. Huge disparities exist between standards in countries such as France, Germany, and The Netherlands on the one hand, and those in Spain, Greece, and Italy on the other, says Broekhuizen. Much of the rest of the EU lies somewhere between these two poles, he says.
Rob Camp of Federación por Informaciones Tratamientos (FIT), the Spanish treatment advocacy group, described some of the problems Spain faces. Viral load testing is still not available except as a research tool, and earlier this year 62 Spanish nongovernmental AIDS organizations signed on to a demand for viral load testing to be fully funded. They are still waiting, just as Spaniards were still waiting at the time of the Birmingham meeting for reimbursement approval from the Spanish health ministry for indinavir, saquinavir, and 3TC.
Such lassitude is all the more surprising when one learns that Spain is the worst-affected country in Europe. With 191 cases per million inhabitants, Spain is the only European country with an epidemic that matches that of the US in severity. The major difference between Spain and the US is that 65 percent of Spanish AIDS diagnoses occur among injecting drug users. Early treatment is still relatively rare in Spain; the median CD4+ count at diagnosis, according to a recent study, was 181. FIT estimates that less than 5000 people with HIV have access to triple combination therapy through major clinics. The standard of care for the others is likely to remain monotherapy, or two drugs at best, until physician education has advanced considerably.
To expedite this advance, FIT publishes a newsletter and a document which outlines the standard of care devised by the International AIDS Society. But these publications can reach only 4500 people, a drop in the ocean in a country where approximately 135,000 people have already been diagnosed HIV-positive.
The experience of French activists was described by François Houyez of ACT UP Paris. Since 1993 France's major AIDS organizations concerned with education and advocacy have been working together in an organization called TRT-5 (Traitements et Recherche Therapeutique Cinq). The organization represents the combined positions of Action Traitements, AIDES, Arcat-SIDA, ACT UP Paris, Sol en Si, and Vaincre le SIDA (the national fundraising organization). Activists saw the need to combine, said Houyez, to counter the divide and rule tactics being pursued by government and some pharmaceutical companies. Since 1993, TRT-5 has been spectacularly successful in developing productive partnerships with government, researchers, and industry. TRT-5's pressure was instrumental in securing early access and reimbursement for indinavir and ritonavir in France, and the coalition has worked closely with the French regulatory agency to ensure speedy access to new treatments. TRT-5 is also represented on French research committees. In this respect France is not unique, but the degree of formal consultation is.
Dutch reimbursement victory
Another success story from Europe, as reported in September's "Inside the EU" column here, is the achievement of Dutch AIDS organizations in persuading Holland's Health Minister, Dr Els Borst, to reverse her hardline opposition to reimbursement for anti-HIV drugs approved without lengthy clinical endpoint trials. She had justified her stance by saying that she wished to avoid "another thalidomide." Historically, The Netherlands has long had a restrictive attitude towards the licensing of new therapies, an attitude that reflects the county's efforts to keep prescribing costs down. As I reported in the May 1996 Journal, the Dutch had adopted a system that clustered drug prices by disease category and then reimbursed only for the cheapest products, regardless of efficacy. This approach was intended to force companies to "bid down" drug prices, and costs were further controlled by placing a temporary moratorium on new drugs which appeared to be "me too" products. This mechanism initially blocked access to ddC in The Netherlands, although the restriction was later relaxed. These policies appeared to block any prospect of combination therapy becoming the standard of care in The Netherlands, despite powerful support for the approach among patient advocates and leading physicians.
The Dutch HIV Association had taken a strong position in support of dual combination treatment even in the months before the 1994 Glasgow meeting marked the advent of the ZDV/3TC era. The radicalism of this position stands in stark contrast to that of many other European countries, where, until very recently, AIDS organizations have been much more reticent about committing themselves to advocacy for particular treatment strategies. The Dutch confidence was no doubt bolstered by the proximity of Joep Lange, MD, PhD, who played an important role in lobbying the Dutch government. "In the days when it was still forbidden to speak of hope for PWAs," said Nico Hollander, "Joep Lange spoke out in support of wider access to protease inhibitors, and insisted that these drugs should be seen as part of a potential cure for AIDS."
Dutch efforts were also enhanced by the clout of Dick Daes, former Health Minister and now head of the Dutch AIDS Fund. Activists briefed all Dutch MPs and ministers in early 1996, and launched a media campaign highlighting the plight of PWAs who could not get access to drugs despite their approval in the United States. One of these was Nico Hollander's partner, who was fighting to get access to ritonavir, and he was among the PWAs who personally wrote to Borst appealing for a more liberal reimbursement policy.
In the spring of 1996, Borst relented, and promised that henceforth any drug given a favorable review by the EMEA's scientific advisory committee would become immediately reimbursable in The Netherlands, even though it might not receive marketing authorization from the European Commission for a further three to four months. This decision ensured that Dutch patients would have unrestricted access to new drugs before almost two-thirds of other patients in the European Union. Only German and Austrian patients enjoy similar opportunities prior to an EU marketing authorization.
The Dutch experience shows the importance of compassion in forming public policy on AIDS. That may be an obvious statement, yet it is becoming clear that the ethical calculus of public health in some European countries is becoming increasingly subordinate to the dictates of fiscal probity.
The Dutch experience also shows the importance of alliances between national AIDS organizations. Some European countries have more sophisticated national coalitions than others, and some activists at the Birmingham satellite meeting took this as a sign that some countries have profound internal problems when it comes to creating domestic alliances between AIDS organizations. But the trajectory of activism has differed from one country to another, and there is, as British writer Simon Watney once pointed out, a natural history of treatment activism in just the same way as there is a natural history of HIV disease, and the rate of presentation of activism in different countries has a lot to do with medical practice and cultural assumptions. Didier Lestrade of ACT UP Paris noted, apparently in ignorance of the implications of his statement, that the Dutch accomplished everything they did without the need to resort to direct action (for which read the ACT UP Paris model). Similarly, educational strategies have evolved very differently in European countries. In France and Germany national networks of AIDS organizations exist. In the UK and Spain they do not. This immediately sets up a situation where AIDS organizations are inclined to compete rather than cooperate.
But it would be unwise of activists' adversaries (or partners, depending on context) to assume that these differences make it easy to play off countries one against the other, or to pick off organizations less favorable to a pharmaceutical agenda. There is a remarkable degree of consensus among European activists on the big issues, such as the design of compassionate release schemes and the need for accelerated approval mechanisms, which has been absent in the recent history of US treatment activism. What has been lacking until very recently is any productive partnership with US activists, who have not understood the relevance of European developments for their own backyard.
This article was provided by International Association of Physicians in AIDS Care. It is a part of the publication Journal of the International Association of Physicians in AIDS Care.