Evidence map›Paper›PMID 28717397›Full record

ArticleEcancermedicalscience2017

How do we avoid disaster when exiting the European Medicines Agency? Making the most of Brexit in pharmaceutical regulation.

Anthony James Hatswell

Abstract readEditorial
In one paragraph

Article in Ecancermedicalscience, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. The Impact of Brexit on Pharmaceuticals and HTA.PharmacoEconomics - open · 2018
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

Anthony James HatswellBresMed Health Solutions, North Church House, 84 Queen Street, Sheffield S1 2DW, UK and.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As the UK prepares to leave the EU, it must decide what path it is to take with a large number of regulatory and technical agencies who provide collaboration at the European level. In the case of pharmaceuticals, the European Medicines Agency (EMA) provides pan-European licencing for novel pharmaceuticals. Should the UK depart from the EMA system, this article highlights the loss to patients immediately (slower access to novel treatments), and in the long term by having no access to some novel products as companies choose not to launch in the UK. The lack of access then may also preclude the access to these treatments as generic medicines, causing harm far into the future. The other costs considered are the cost for duplicating the functions of the EMA, or the alternative of using the decisions of other regulators without input to decisions made. An alternative is then set out, of how the UK can prosper under 'Brexit', by remaining a member of the EMA, but accepting the decisions without political oversight (as currently happens with the European Commission). Additional freedom could be given to a UK regulator to accept decisions (where appropriate) from other agencies such as the Food & Drug Administration-further speeding access and making the UK a more attractive market. Such an arrangement would put the UK in a better position than the good position it is in currently. This would give patients (both now and in the future) the best access to treatment possible, and promote/attract an industry which employs (directly and indirectly) 500,000 jobs.

Indexed as

EMAFDAmarket accessregulatory

Identifiers

PMID28717397
PMCPMC5493438

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.