Corinna Sorenson

Improving Medical Device Regulation: The United States and Europe in Perspective

CONTEXT Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. METHODS We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. FINDINGS The two regulatory systems differ in their mandate and orientation, organization, pre- and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. CONCLUSIONS Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium- and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices.

Medical technology as a key driver of rising health expenditure: disentangling the relationship.

Health care spending has risen steadily in most countries, becoming a concern for decision-makers worldwide. Commentators often point to new medical technology as the key driver for burgeoning expenditures. This paper critically appraises this conjecture, based on an analysis of the existing literature, with the aim of offering a more detailed and considered analysis of this relationship. Several databases were searched to identify relevant literature. Various categories of studies (eg, multivariate and cost-effectiveness analyses) were included to cover different perspectives, methodological approaches, and issues regarding the link between medical technology and costs. Selected articles were reviewed and relevant information was extracted into a standardized template and analyzed for key cross-cutting themes, ie, impact of technology on costs, factors influencing this relationship, and methodological challenges in measuring such linkages. A total of 86 studies were reviewed. The analysis suggests that the relationship between medical technology and spending is complex and often conflicting. Findings were frequently contingent on varying factors, such as the availability of other interventions, patient population, and the methodological approach employed. Moreover, the impact of technology on costs differed across technologies, in that some (eg, cancer drugs, invasive medical devices) had significant financial implications, while others were cost-neutral or cost-saving. In light of these issues, we argue that decision-makers and other commentators should extend their focus beyond costs solely to include consideration of whether medical technology results in better value in health care and broader socioeconomic benefits.

Medical technology procurement in Europe: a cross-country comparison of current practice and policy

Procurement policy can influence the diffusion of medical devices into national health systems, but limited comparative evidence exists on how countries procure such technologies. This paper discusses the procurement of select medical devices across five countries (England, France, Germany, Italy, and Spain) based on a review of published and grey literature and policy documents, as well as expert interviews. All countries have introduced various regulatory or policy measures that implicitly or explicitly influence device procurement, from lists of devices for purchase to changes in financing mechanisms. There has also been movement toward more centralized procurement with the introduction of purchasing groups or consortiums, notably in England, France, Germany, and Italy. While a number of stakeholder groups are involved in purchasing activities, a greater, more formalized role for physicians and governments is needed to ensure that technologies procured best meet patient needs and align with national health care priorities and other sectoral objectives. A general theme across all national procurement systems was a focus on cost-containment, but like other areas of technology policy (e.g., coverage), basing purchasing decisions on a broader range of criteria, such as quality and health outcomes, might better allow governments to achieve value for money and support patient access to beneficial innovations. More research is needed, however, to substantiate the role and influence of procurement on balancing the adoption and affordability of medical technologies.

Nasty or Nice? A Perspective on the Use of Health Technology Assessment in the United Kingdom

Health technology assessment (HTA) has a long history in the United Kingdom. The first study undertaken to inform a central policy decision was the economic evaluation of screening for tuberculosis using mass miniature radiography [1]. Another well-known study was the evaluation of the heart transplant program, commissioned by the Department (i.e., Ministry) of Health (DH) to decide whether to expand heart transplant facilities [2]. Health technology assessment expanded rapidly in the 1990s, following the decision to spend up to 1.5% of the National Health Service (NHS) budget on research and development (R&D). The HTA program, which commenced in 1993, became one of the largest R&D programs and this led to the establishment of the National Coordinating Centre for Health Technology Assessment (NCCHTA) in June 1996. The Centre commissions and coordinates a wide-ranging program of primary and secondary research in HTA. However, the international profile of HTA in the United Kingdom greatly increased with the establishment of the National Institute for Clinical Excellence (NICE) in 1999, renamed the National Institute for Health and Clinical Excellence in 2005. Here the difference was that not only were HTAs to be conducted, but the results would be used in developing guidance for the NHS on the use of health technologies. Such has been the impact of NICE, both in the UK and beyond, that the Institute’s activities have become synonymous with the conduct of HTA in the United Kingdom. Therefore, this article will focus mainly on the activities of NICE, given in Section I, discussing NICE’s major achievements given in Section II, major issues unresolved given in Section III, and lessons for other jurisdictions given in Section IV.

Evidence of comparative efficacy should have a formal role in European drug approvals

Despite methodological concerns, comparative efficacy evidence should be required at the time of drug approval, says Corinna Sorenson and colleagues, to allow patients, clinicians, and other healthcare decision makers to determine whether a new drug is superior, equivalent, or inferior to its existing alternatives

Public Financing of IVF: A Review of Policy Rationales

There is great diversity in in vitro fertilization (IVF) funding and reimbursement policies and practice throughout Europe and the rest of the world. While many existing reimbursement and regulatory frameworks address safety and legal concerns, economic factors also assume a central role. However, there are several problems with the evidence that is available on the economics of IVF. This suggests there is a need for more robust cost-effectiveness studies. It also indicates the need for alternative rationales to justify the reimbursement of IVF, which might more fully account for the social, political, ethical, and philosophical considerations embedded in notions of infertility and technology-driven reproductive treatments. The merits and limitations of five alternative rationales are discussed. The review suggests that while no existing single rationale provides a complete framework with which to support funding decisions, taken together they provide guideposts which signal important issues for consideration and highlight where further research, action, and debate are needed.

Reflections on the evolution of health technology assessment in Europe

Health technology assessment (HTA) has assumed an increasing role in health systems in recent years, with many countries establishing agencies or programmes to evaluate health technology and other interventions to inform policy decisions and clinical practice. This paper reflects upon its development and evolution in Europe over the last decade, with a focus on England, France, Germany and Sweden. In particular, we explore how HTA has evolved over time as well as its impact on policy and practice. While countries share many of the same objectives, there are differences in the way HTA agencies and programmes are organised, operate, and influence decision making. Despite these differences, all systems are faced with opportunities and challenges related to stakeholder involvement and acceptance, the suitability and transparency of assessment requirements and methods, balancing evidence and values in decision making, and demonstrating impact.

Evolving Reimbursement And Pricing Policies For Devices In Europe And The United States Should Encourage Greater Value

Rising health care costs are an international concern, particularly in the United States, where spending on health care outpaces that of other industrialized countries. Consequently, there is growing desire in the United States and Europe to take a more value-based approach to health care, particularly with respect to the adoption and use of new health technology. This article examines medical device reimbursement and pricing policies in the United States and Europe, with a particular focus on value. Compared to the United States, Europe more formally and consistently considers value to determine which technologies to cover and at what price, especially for complex, costly devices. Both the United States and Europe have introduced policies to provide temporary coverage and reimbursement for promising technologies while additional evidence of value is generated. But additional actions are needed in both the United States and Europe to ensure wise value-based reimbursement and pricing policies for all devices, including the generation of better pre- and postmarket evidence and the development of new methods to evaluate value and link evidence of value to reimbursement.

The Politics of Comparative Effectiveness Research: Lessons from Recent History

Efforts to support and use comparative effectiveness research (CER), some more successful than others, have been promulgated at various times over the last forty years. Following a resurgence of interest in CER, recent health care reforms provided substantial support to strengthen its role in US health care. While CER has generally captured bipartisan support, detractors have raised concerns that it will be used to ration services and heighten government control over health care. Such concerns almost derailed the initiative during passage of the health care reform legislation and are still present today. Given recent investments in CER and the debates surrounding its development, the time is ripe to reflect on past efforts to introduce CER in the United States. This article examines previous initiatives, highlighting their prescribed role in US health care, the reasons for their success or failure, and the political lessons learned. Current CER initiatives have corrected for many of the pitfalls experienced by previous efforts. However, past experiences point to a number of issues that must still be addressed to ensure the long-term success and sustainability of CER, including adopting realistic aims about its impact, demonstrating the impact of Patient-Centered Outcomes Research Institute (PCORI) and communicating the benefits of CER, and maintaining strong political and stakeholder support.

Balancing intellectual monopoly privileges and the need for essential medicines

This issue of Globalization and Health presents a paper by Kerry and Lee that considers the TRIPS agreement and the recent policy debate regarding the protection of public health interest, particularly as they pertain to the Doha Declaration. In this editorial, we consider the debate, the conclusions thereof, and identify five questions that should be considered by key stakeholders in ongoing discussions.