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Reflector is Pharm Exec's Brussels correpsondent.
Pharma hopes for a deal are fading as the once-hot TTIP talks seem to be on the fizzle in Europe.
Only a year ago, hopes were high of rapid progress towards a transatlantic trade deal that would boost the European and US economies—and ease conditions for drug firms on both sides of the ocean. TTIP, the Transatlantic Trade and Investment Partnership, was the hot tip for a 2014 success story. But as summer slides away and autumn beckons, the latest read-out of progress suggests that rather than remaining a hot tip, TTIP now risks being tipped into oblivion.
Results are few, talks are tangled, agreement remains distant, energy is flagging, and skepticism and hostility are rising. Already the ghost of the Anti-Counterfeiting Trade Agreement (ACTA)—an international agreement to limit counterfeiting that fell a fatal victim to public distrust after years of preparation—is hovering over the TTIP discussions. Critics of TTIP have mobilized fast and efficiently, and are currently way out ahead in the battle for public opinion.
The pharma industry has something to gain from a successful outcome—as its investment in lobbying on the talks demonstrates. And it faces some real losses from a failure, because that would demonstrate that the limits to international regulatory coordination are being reached, and that the business community in general is losing its ability to counter arguments not just embraced by ideological activists, but also endorsed by wide swathes of the public.
The engagement of the pharma industry in particular, and the healthcare sector in general, can be gauged from the participation at a recent Brussels event. Conspicuous among the 300-plus organizations admitted were the major drug and devices industry associations and a solid representation of pharma firms and their proxies in public relations companies, government affairs specialists, and lawyers cabinets.
They featured prominently among the invited speakers, with the European Federation of Pharmaceutical Industries & Associations (EFPIA) discoursing on fostering innovation and regulatory convergence for the transatlantic pharmaceutical sector, the European Generics Association (EGA) on the public interest in regulatory cooperation on generic and biosimilar medicines, and the Association of the European Self-Medication Industry (AESGP) on the prospects for non-prescription and well-established medicines. US backup was evident in presentations from the Alliance for Healthcare Competitiveness, which "advocates for improved access to healthcare products and services across borders," and numbers among its members the main US drug industry association, PhRMA, as well as companies including Abbott and Johnson & Johnson.
They were also numerous interests in the audience, including Amgen, BASF, J&J, LEO Pharma, and Novartis, as well as the biotech federation Europabio, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), the device manufacturers in Eucomed, and the European Diagnostic Manufacturers Association (EDMA). Polish companies were also present, through a new national association, Go Global! Polish Pharma, and firms such as Adamed.
But the gap between aspirations and realizations was evident in the official account given to the meeting of how far the talks had proceeded. This came from the two leading figures in TTIP, the EU's chief negotiator, Ignacio Garcia Bercero, and his US counterpart, Dan Mullaney, who "offered insight into the discussions so far and prospects," after the just-concluded sixth round of negotiations. In the areas of interest to the pharma sector, the pickings are slim indeed, to judge from their account.
Specifically on pharmaceuticals, all that could be said officially was: "The two sides held discussions with a view to reaching a better understanding of each party's respective systems. Discussions focused on, among others, good manufacturing practices and biosimilars. Both sides intend to intensify technical work with a view to examine the scope for mutual reliance/recognition on each other's inspections of manufacturing facilities." Similarly, on medical devices, the report reads: "Discussions so far have focused on unique device identification, regulatory product submission, and medical devices single audit program. Discussions helped to clarify the respective positions and to better understand the functioning of the regulatory systems of both sides, and will continue at technical level."
Hardly a breakthrough for manufacturers. And on some of the other areas in the talks where the healthcare industry was buoyed up by ambitions a year ago, the outcome so far is, to say the least, meager. On intellectual property rights, "the two sides are currently engaged in discussions aiming to define the architecture of the chapter and identify potential topics to be addressed." On information and communication technology (ICT), "the two sides continue to exchange views on key concepts and scope to help develop discussions in the fields of e-health." And on regulatory coherence, the two sides "have exchanged several non-papers outlining their respective objectives and have been engaging in a thorough exchange of information with a view to ensuring a more in-depth understanding of each other's respective regulatory systems, discussing means of improving upstream regulatory cooperation, stakeholder involvement, and strengthening the analysis of international trade effects when carrying out impact assessments."
Mullaney added, in his remarks, that "the regulatory coherence discussions will produce efficiencies for traders and regulators, allowing the latter to concentrate on higher-risk issues (e.g., the area of medical devices)." Still rather short of an action-packed list of achievements.
Meanwhile, the level of concern about the risks from the talks has been raised sharply by TTIP's opponents. The meeting itself was interrupted by—as the official account laconically reports it—"a small number of representatives of non-governmental organizations." They "staged a short reading of a prepared statement to voice their concerns...which called for more transparency in the negotiations, and highlighted the potential impact on the democratic decision-making process in the EU of TTIP provisions on regulation and public services."
This was far from the only manifestation of such concern. For months now, Brussels has been awash with statements ranging from refined caution to outright denunciation of the entire process. In the new European Parliament, Green MEPs have already urged a reboot of the talks and a new start on different terms, while far-left groups are flatly demanding an end to the negotiations. Presentations at the meeting highlighted some of the concerns—notably from Emma Woodford, interim Secretary General of the European Public Health Alliance, who spelled out what her members see as the public health impacts of TTIP. Among her concerns are risks that it will undermine governments' ability to regulate in health matters. At a time chronic and lifestyle-related diseases are on the increase, "looser regulatory frameworks that allow global firms to practice deceptive marketing practices would only serve to worsen this situation," in Woodford's view.
The two chief negotiators tried, at the meeting, to respond to the many accusations that the talks are undemocratic and will erode society's values. The negotiations "are already conducted with an unprecedented level of transparency," they said, with "many outreach events, public documents, and open door policy on both sides of the Atlantic intended to help ensure that everyone can have their say and be heard by the negotiating teams."
The EU negotiator also pointed out that the European Commission, as the negotiator on behalf of the EU, "is operating based on a mandate granted by member state governments, and their representatives and the democratically elected European Parliament has full access to information about the TTIP negotiations in real time via frequent briefings from the Commission." He also underlined that "it is the European Parliament which will need to ratify the agreement before it can come into force."
The attempt at reassurance can be seen as a two-edged sword for these talks. It was the European Parliament that killed off ACTA. And the much-vaunted transparency around these talks appears at present to be having the effect of raising rather than reducing levels of concern. In the healthcare field, it is notable that the participants at the July event also included organizations as diverse as the British Medical Association, the Department of Health, Ethics and Society at Maastricht University, the European Heart Network, the EU representation of French social security systems, and the General Pharmaceutical Council of Spain, as well as campaigners such as Health Action International, MSF Access Campaign, and Oxfam International.
And if it wasn't complex enough already, the latest challenge—concerns over provisions for investor state dispute settlements—has become a new rallying point for opposition among healthcare activists. Campaigners claim it poses a threat to the supply of cheaper medicines in Europe. Health Action International Europe wants it eliminated from the talks, to reduce its "potential to jeopardize access to affordable medicines." EPHA says it could allow businesses to bypass national court systems and sue governments directly over measures that can jeopardize future profits—typically laws designed to protect the public. And the extent of public concern can be judged by the fact that a just-completed consultation launched in March by the European Commission had received nearly 150,000 responses by mid-July. What was once a hot topic may be morphing into a cold freeze—and with a long summer fading to autumn, the outlook from Europe looks increasingly uncertain.
Reflector is Pharmaceutical Executive's correspondent in Brussels.