Regulating Medicines in Europe

Abraham, John; Lewis, Graham

doi:10.4324/9781315008899

Cited by 11 publications

(8 citation statements)

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“…First, previous studies suggest that drug crises and subsequent withdrawals exert strong, if not decisive, impacts on drug policies, especially after the early 1960s thalidomide disaster (Lumpkin et all, 2012;Shah, 2001;Brynner & Stephens, 2001;Winship, Hepburn & Lawson, 1992;Gardner, 1996), and conclude that regulatory changes occur primarily in times of crises. Other studies have criticized this emphasis on the role of disruptive events in drug policy changes (Abraham & Lewis, 2000), arguing that policy changes result from longer-term, social processes that resonate with slowly evolving political and economic factors. For example, despite several high-profile incidents and drug withdrawals, no policy shifts toward taking patient interests into account occurred in the U.K. in the 1980s (Abraham, 1997).…”

Section: Discussionmentioning

confidence: 99%

“…As drug withdrawals implicate multiple stakeholders including pharmaceutical companies, medical professionals, patients, the general public and regulators (Abraham & Lewis, 2000), some cases may draw public attention, instigate debate and ultimately lead to changes in health policies. Previous work portrays such policy changes either as governments' and regulatory agencies' responses to crises (Shah, 2001;Brynner & Stephens, 2001;Temin, 1985), or as longer-term outcomes with of conflicts among stakeholders in the health field (Abraham & Lewis, 2000). Both perspectives provide insights, but they also tend to overstate the two ends of the policy-making chain by accentuating either the role of governments and regulators or the role of wider societal stakeholder tensions.…”

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confidence: 99%

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Parliament in action: Drug withdrawals and policy changes in the U.K.

2020

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Parliament in action: Drug withdrawals and policy changes in the U.K.

2020

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“…A pharmaceutical's regulatory status is revisited when adverse effects are reported, and when post-marketing surveillance provides evidence of harm (Abraham and Lewis 2000;. Food and drug authorities have standing committees that review new evidence and decide if the regulatory status of a product needs to be revised.…”

Section: Unevenness Of Harm Protection Mechanismsmentioning

confidence: 99%

Chemical Youth

Hardon¹

2021

Critical Studies in Risk and Uncertainty

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“…Significantly, the Nordics are generally known for transparency and openness in policymaking, 31 including related to pharmaceuticals. 32,33 They should therefore offer a critical test of the EFPIA selfregulatory framework's ability to ensure transparency. Furthermore, the Nordics are commonly perceived as quite similar when viewed from a broader international perspective, meaning that policies and practices of industry funding and transparency should be comparable and insights readily transferable.…”

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Disclosure of Pharmaceutical Industry Funding of Patient Organisations in Nordic Countries: Can Industry Self-Regulation Deliver on its Transparency Promise?

2022

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Pharmaceutical companies regularly fund patient organizations. It is important for patient organizations’ credibility that there be transparency regarding this financial support. In Europe, the pharmaceutical industry promises to deliver transparency through self-regulation, as opposed to legally binding provisions, but self-regulation's effectiveness is contested. We compared the industry's transparency of funding in four Nordic countries that, given their general reputation for high transparency, offered a critical test of self-regulation's ability to deliver on its transparency promise. For 2017–2019, we compared: national rules regarding funding disclosure; disclosure practices as evidenced by the availability, accessibility, and format of company transparency reports; and disclosure data, including payment descriptions and sums. Transparency problems differed in kind and magnitude between countries. In Norway and Finland, unlike in Sweden and Denmark, data on funding were difficult to access and analyze and sometimes seemed incomplete or missing. We explain that a key factor allowing for country differences is the freedom given to a country's pharmaceutical industry trade associations to form self-regulatory rules, provided they do not fall below the weak, European-level minimum requirements. Transparency could be improved by aligning rules and practices with the FAIR data principles: that is, corporate disclosures should be findable, accessible, interoperable, and reusable.

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Regulating Medicines in Europe

Cited by 11 publications

References 0 publications

Parliament in action: Drug withdrawals and policy changes in the U.K.

Parliament in action: Drug withdrawals and policy changes in the U.K.

Chemical Youth

Disclosure of Pharmaceutical Industry Funding of Patient Organisations in Nordic Countries: Can Industry Self-Regulation Deliver on its Transparency Promise?

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