Regulation of therapeutic goods has two purposes that are sometimes at odds with each other. Regulation seeks to safeguard the public’s health and safety, while allowing or even incentivising beneficial innovations to reach the market as quickly as reasonably possible. In current systems, a major part of how regulation achieves both aims is the requirement that manufacturers present evidence of a product’s safety and effectiveness. On the one hand, this protects consumers from using products that are unsafe or won’t be beneficial. On the other, it means that commercial success must be based on sound research, incentivising quality innovation.
Any such approach to regulation must deal with difficult questions about the standard of evidence it will require. Answering these questions requires not only scientific input, but ethical decisions, since it will involve judgements about what levels of risk are acceptable, and which of the two aims should outweigh the other. If evidentiary standards are too low, regulators’ safeguarding role might be compromised; too high and they may unnecessarily prevent patients from benefiting from new advances.
Partly to compensate for the difficulties of pre-market evidence collection, most jurisdictions expect manufacturers to undertake post-market studies and other “vigilance” activities such as adverse event reporting. While this might be a good solution in theory, sometimes requirements for post-market studies have not been enforced, and there is often under- or inconsistent reporting of adverse events. It also raises the ethical worry that, to the extent that the evidence for safety and effectiveness is collected post-market, the first patients to use a device are de facto research subjects. Yet they are not protected, as subjects in pre-market research studies are, by ethical oversight and informed consent procedures. On the contrary, many consumers assume that any product on the market has been thoroughly assessed for safety and effectiveness.
As advances further challenge the current system, it is worth questioning whether there could be alternative approaches to device regulation. Most radically perhaps, we could question the way current regulatory approaches incentivise research by linking it to commercial success. This link itself leads to ethical issues, such as that research is primarily directed towards addressing the health problems of the most well-off. Healthcare inequities are likely to increase with increasing technological sophistication, since this comes with increased cost. Some technologies also have the potential to reduce inequities, such as using 3D printing to provide lower-tech devices in low-income countries—but while research is incentivised as it currently is, this potential may not be fulfilled. That healthcare innovation primarily focuses on marketable products can also lead to neglect of improvements that could be made through social or institutional change.
Admittedly, making research necessary for commercial purposes, while in these respects not an ideal feature of a regulatory approach, might be the best possible one overall (and certainly be extremely difficult to change). Less radically then, we might question the way the current system is arranged around the pre-/post-market distinction, and the corresponding research subject/patient distinction. Other options, like creating a third category between research and practice, or developing new methods for post-market investigation (including ethical oversight where appropriate) or compliance, are worth considering.
1. The author suggests that the two primary goals of regulating therapeutic goods are ________.
2. According to the passage, setting evidentiary standards for regulation involves ethical decisions mainly because ________.
3. What ethical concern does the author raise about post-market studies?
4. The author implies that linking research to commercial success may ________.
5. In the final paragraph, the author suggests that one less radical way to reform regulation is to ________.
A.ensuring public safety while promoting timely medical innovation
B.protecting the interests of manufacturers and reducing production costs
C.encouraging scientific research while limiting government intervention
D.reducing ethical risks while increasing commercial competition
A.regulators must choose which kinds of medical products to approve
B.ethical committees are responsible for verifying safety standards
C.evidence collection often depends on manufacturers’ moral integrity
D.it requires balancing acceptable risks and the goal of innovation
A.They often prioritize corporate profits over scientific accuracy.
B.They may turn early consumers into unprotected
C.They rely too heavily on data collected from low-income countries.
D.They replace pre-market testing, making clinical trials unnecessary.
A.encourage research into affordable healthcare solutions
B.promote technological equality between rich and poor countries
C.intensify existing inequities in access to healthcare innovations
D.discourage investment in high-cost medical technologies
A.eliminate the pre-market testing phase altogether
B.replace the commercial incentive system with government funding
C.reconsider the distinction between pre- and post-market stages
D.strengthen penalties for companies that violate ethical standards
