Evidence map›Paper›PMID 28670455›Full record

ReviewJournal of pharmaceutical policy and practice2017

Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union:

Ellen F M 't Hoen, Pascale Boulet, Brook K Baker

Abstract readReview
In one paragraph

Review in Journal of pharmaceutical policy and practice, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. 3D Printing, Intellectual Property Rights and Medical Emergencies: In Search of New Flexibilities.IIC; international review of industrial property and copyright law · 2022
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Return of Benefit to Society of Publicly Funded Innovations to Combat COVID-19.Inquiry : a journal of medical care organization, provision and financing
    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

3 authors.

Ellen F M 't HoenUniversity of Groningen, University Medical Center Groningen, Global Health Unit, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.
Pascale BouletConsultant Medicines Law & Policy, 105 route de Lossiège, 74130 Contamine sur Arve, France.
Brook K BakerNortheastern University School of Law, 400 Huntington Ave., Boston, MA 02115 USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The challenge of providing access to high-priced patented medicines is a global problem affecting all countries. A decade and a half ago the use of flexibilities contained in the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights, in particular compulsory licensing, was seen as a mechanism to respond to high-price medicines for the treatment of HIV/AIDS in low- and middle-income countries. Today a number of upper-income European Union (EU) Member States are contemplating the use of compulsory licensing in their efforts to reduce expenditure on pharmaceutical products. EU regulation of clinical test data protection and the granting of market exclusivity interfere with the effective use of compulsory licensing by EU Member States and can even prevent access to off-patent medicines because they prohibit registration of generic equivalents. EU pharmaceutical legislation should be amended to allow waivers to data and market exclusivity in cases of public health need and when a compulsory or government use license has been issued. Such an amendment can be modelled after existing waivers in the

Indexed as

Access to medicinesCompulsory licensingData exclusivityEuropean UnionIntellectual propertyMarket exclusivityMedicines pricingPatents

Identifiers

PMID28670455
PMCPMC5490222

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.