EMDM Industry News
Global Device Conference Notes Progress in Harmonization Efforts
"We have a saying about the weather in Sydney: beautiful today, perfect tomorrow," Trish Worth, parliamentary secretary to Australia's Minister for Health and Family Services, told attendees of the Global Medical Devices Conference. In her opening remark, Worth proved to be prescient about more than the local climate. In contrast to the acrimony that often came to the surface at the previous meeting in Lisbon, the seventh conference, held in Sydney on 15–17 February, effortlessly lived up to its title: Global Harmony 1998.
Joseph Putzeys, head of the European Commission's industrial affairs unit, Directorate General III, and chair of the Global Harmonization Task Force, set the tone by lavishing praise upon the work of GHTF's four study groups. In particular, Putzeys singled out a comparative study of national regulatory systems drawn up by Study Group I. The document, which will be submitted to GHTF for comment, establishes the existence of numerous similarities in the various systems that extend far beyond quality assurance procedures. The paper could be the foundation for a "set of essential requirements that would guarantee the safety of medical devices around the world," said Putzeys. Regional authorities could verify their degree of compliance against these safety requirements, but this would not preclude the existence of national differences, he said. Putzeys stressed that the goal of harmonization has not been abandoned and characterized this approach as a practical measure designed to maintain current momentum.
He also cited substantial progress made by SG II in its efforts to harmonize adverse incident reports. Common data sets and reporting rules have been drafted, and the exchange of information between competent authorities has been standardized.
Philosophical Differences
While US FDA officials Linda Horton and Larry Kessler, both from the agency's Center for Devices and Radiological Health, largely shared the expansive mood—Kessler, at a press conference, likened the steady rate of progress made in the last 12 to 18 months to the inexorable progression of a steamroller—they did draw attention to a philosophical difference between the EU and US that may hinder more substantive harmonization efforts for some time to come.
"There remains a conceptual framework difference between the US and the EU, and perhaps the rest of the world," said Kessler. "It is our insistence on maintaining safety and effectiveness information as opposed to safety and performance. The US wants to show that a device doesn't just do what it says it does, but that it also benefits the patient." This fundamental divergence with the EU approach, continued Kessler, is the principal obstacle in expanding the terms of the mutual recognition agreement (MRA) to include high-risk devices. While Kessler cautioned industry and regulators against discounting the importance of this conceptual gap, he also urged the global community to persevere in its goal of harmonization and perhaps even push FDA to do more. "If all of you who feel that the methods of FDA are somewhat Byzantine—industry, notified bodies, regulators—were to go home after this conference and work together on an [alternative] product approval system, I would encourage you to submit that to us. If we could come to some sort of agreement on a guidance document, that will allow us to continue to move toward true global harmonization."
On the subject of MRAs, it was also announced at the conference that there has been some delay in signing the agreement between the EU and Australia. It now appears that it will not go into effect until September, at the earliest. Terry Slater, national manager at Australia's Therapeutic Goods Administration (TGA), also announced that Australia will not adopt Europe's third-party review system and that TGA will continue to evaluate and approve devices. "We recognize the ingenuity of the system in helping to create a single market in the European context," said Slater, but that need does not exist in Australia.
Asian Opportunities
Despite the economic upheaval that the Asian region is currently experiencing, speakers presenting papers on the Asian markets stressed prospects for continued growth in the medical sector. There is still a lot of accumulated wealth in these countries and ample opportunities remain for device manufacturers, said Edward M. Rozynski, executive vice president of global strategy and analysis at the Health Industry Manufacturers Association (HIMA; Washington, DC, USA). With the exception of Japan, which is expected to achieve 6% growth in its medical device market in 1998, HIMA projects nearly 12% overall growth throughout the region. Rozynski did offer one caveat, however: "That figure should be understood in terms of the local currency. We can't predict what will happen with the exchange rates.
"Don't give up on Asia," Rozynski concluded. "Stay the course, ride out the turmoil, and you will find great opportunities."
The Chinese market and regulatory system were explored in great depth at a Focus on China workshop chaired by Roberta Lipson, CEO of Chindex International Inc. (Beijing), a distributor of medical equipment. Lipson acknowledged that penetrating the Chinese market can be a "frustrating" experience for foreign manufacturers, particularly in the regulatory arena, where it is not uncommon to encounter overlapping demands from different government agencies. The approval process may become yet more burdensome if a new set of regulations is approved that would require manufacturers to submit product registration information and test samples to the Ministry of Health as well as the State Pharmaceutical Administration of China. (According to Lipson, there are indications that the State Council may be reluctant to introduce more redundancies in the regulatory process and has not yet approved the decree.) Foreign firms willing to navigate the maze of regulations, however, can enjoy unprecedented access to one of the world's greatest untapped markets, she added. The World Bank predicts that China's gross domestic product could double between 1993 and 2001, she said, and the percentage spent on health care could attain 10% during that period.
The Challenges Ahead
So, perfect tomorrow? While the immediate future is promising, several speakers saw some dark clouds forming on the more distant horizon for industry. According to Rozynski, three concerns should be at the top of industry's list: "cost containment, cost containment, and cost containment." Noting that pressure to drive down health-care expenditures spans the globe—he cited France's TIPS system, which recently slashed reimbursement on some products by as much as 40%—Rozynski devoted much of his time to the situation in emerging economies. Industry must do a better job of explaining the benefits of medical technology that, contrary to many assumptions, does not necessarily drive up the cost of health care in the long run, he said. "We have to educate governments and regulators and explain to them why they should pay $3 for our product when they can buy one that is locally produced for $1." Rozynksi also stressed the need to lobby for more-transparent regulatory schemes, particularly in Asian countries, many of which are in the process of developing new registration systems.
Gordon Higson, consulting director of Quintiles–Medical Technology Consultants and chairman of ISO Technical Committee 210, argued that a working model exists to ensure that safe and effective products reach the market in a timely manner: the Medical Devices Directive. "The two groundbreaking developments in my time have been the US Medical Device Amendments of 1976 and the European Medical Devices Directive of 1993," said Higson. Noting that the MDD was built on the foundation provided by the US amendments, Higson added that the European approach introduced several innovations that are serving as a model for device regulations. "The two main developments of the MDD are the concept of safety, articulated in the essential requirements, and a move toward the use of international standards as a preferred means of showing compliance with the essential requirements," he said. These and other innovations—the delegation of certain aspects of conformity assessment to authorized third parties and an emphasis on postmarket controls—will continue to find favour with other administrations even as the system is fine-tuned, Higson predicted. In the future, he said, "we will see the confirmation of these trends apparent today."
The accuracy of these predictions will certainly come under some scrutiny at the next global conference, which is tentatively scheduled to be held under North American leadership in Mexico, probably in Cancún, in February 2000.
