Legal aspects

Last updated: 8 March 2017

Introduction

The HTA Core Model specifies four categories of legal aspects of importance to HTA (1):

• Issues related to health care policy at the local, national or international level

• Issues related directly to the technology in question (e.g. proper authorisation, patent/license issues)

• Issues related to the process of acquisition of the technology

• Issues directly related to the patient and his/her basic rights and freedoms (such as, autonomy, privacy and confidentiality).

In addition, when assessing diagnostic technologies, legal issues related to who is the end-user are also of importance (1).

Sources to search

Legal aspects related to health care policy refer to international or supranational rules and regulations (such as European law) and in particular to national law. Droste and Rixen (2) recommend the use of the following information sources for legal issues directly related to the health technology in question:

• World Health Organization (WHO), World Medical Association (WMA) etc. (International legal norms (incl.rights, conventions etc.))

• European Commission, Council of Europe etc. (Supranational legal norms)

• Governments, parliaments or further legislative authorities (National legal norms)

• National, supranational and/or international authorities (Health legislation)

-Health policy administration, Decision-making bodies, Health insurances etc. (Benefit rights)

-European Medicines Agency (EMA), National agencies etc. (Pharmaceutical legislation)

-Notified Bodies (European Union), National authorities etc. (Medical device law)

-Governments, Parliaments, Authorities with legislative rights etc. (Rehabilitation and care legislation, Hospital law, Remuneration law)

-Medical Council etc. (Professional law)

-Government, Parliament, Legislative Authorities (Criminal law)

-Government, Parliament, Federal / National Court of Justice, Higher District Court etc. (Liability law)

-World Health Organization (WHO), EU Council of Ministers, Government, Parliament, Federal / National Social Court, Federal / National Constitutional Court etc. (Patient rights)

Sources for patents may be consulted when looking for information on whether the technology in question infringes some intellectual property rights or whether the introduction of the technology means there will be additional licensing fees to be paid (1).

Depending on the topic in question, the following information sources (searchable in English language) may be used when searching for legal issues directly related to the patient and e.g. his/her basic rights and freedoms (2):

• Health Technology Assessment (HTA): Cochrane Methodology Register(CMR, currently under review and not updated since July 2012), DARE, HTA

• Biomedicine: Embase, MEDLINE / PubMed, Science Citation Index (SCI) Expanded, MEDIKAT, Databases provided by publishers: SciVerse ScienceDirect, Journals@OVID, Springer

• Ethics: BELIT, Bioethics Research Library at Georgetown University, Euroethics

• Legislation: Global Health and Human Rights Database (3)

• Psychology: PsycInfo, Psyndex

• Social Sciences: Social Science Citation Index (SSCI), SOWIPORT

• Web Portals / Library catalogues: HTAi Vortal, Karlsruhe Virtual Catalog, OpenGrey, Virtual Law Library of the Staatsbibliothek

Further, hand-searching for non-indexed journals and searching of the web pages of relevant health law and ethics institutes may be considered (2).

Designing search strategies

No internationally established standard exists for how to develop search strategies on legal aspects related to health technologies (2). A study by Droste and Rixen (2) introduces a proposal for an information retrieval procedure similar to the workflow of information retrieval for effectiveness assessments.

One should first try to identify relevant laws, rules and regulations, and legal issues relevant to the topic of interest (2). When defining the research question, it is recommended to add an additional category related to the legal aspects to the PICO scheme describing the population, intervention, comparator, and outcomes of interest (PICOL). In databases that allow advanced searching, subject headings and text words describing the relevant legal issues are then combined with search terms characterising the selected relevant PICO categories, with the Boolean operator AND. The paper of Droste and Rixen (2) provides an overview of relevant subject headings for searching for legal aspects in MEDLINE and Embase. Use of less sophisticated search strategies may need to be considered in other types of sources.

Patent information cannot be searched using standardized search approaches and it is considered to be challenging (4). A human recombinant insulin case study by Dirnberger (4) compared the performance of three different search approaches: "crude” keyword search strategy, complex focused keyword search strategy, and sequence search strategy. The best search results in terms of recall and precision were achieved by combining the focused keyword and sequence search approaches.

There is some overlap between ethical, legal and social aspects of health technologies (2). For example, issues of patient autonomy are part of each of these aspects. To avoid duplication of work, joint information retrieval processes for these three aspects may therefore be considered.

Reference list

(1) EUnetHTA Joint Action 2, Work Package 8. HTA Core Model® version 3.0; 2016 (pdf). [Publication appraisal]

(2) Droste S, Rixen S.[Information on legal issues in health technologies: Methodological proposal to identify them in a systematic and comprehensible manner]. Z Evid Fortbild Qual Gesundhwes 2012; 106: 509-522. [Publication appraisal]

(3) Meier BM, Cabrera OA,Ayala A, Gostin LO. Bridging international law and rights-based litigation: Mapping health-related rights through the development of the Global Health and Human Rights Database. Health Hum Rights 2012; 14(1): 20-35. [Publication appraisal]

(4) Dirnberger D. A guide to efficient keyword, sequence and classification search strategies for biopharmaceutical drug-centric patent landscape searches: A human recombinant insulin patent landscape case study. World Pat Inf 2011; 33(2): 128–143.[Publication appraisal]