Intellectual Property Rights and Access in Crisis.

The importance of access to intellectual property rights (IPR) protected subject-matter in two crucial areas - public health, and educational and cultural engagement - has been extensively demonstrated during the COVID-19 pandemic. Although they involve separate legal areas, patent and copyright, the common thread linking the two is intellectual property's difficult relationship with access in the public interest. This paper examines the tensions caused by access barriers, the tools used to reduce them and their effectiveness.

The continuing saga of patents and non-invasive prenatal testing.

Objective: This paper examines the Intellectual Property (IP) landscape for non-invasive prenatal testing (NIPT) in three key regions: the United States; Europe, with particular focus on the United Kingdom; and Australia.

Method: We explore the patent law issues against the commercial and healthcare environment in these regions and consider the implications for development and implementation of NIPT.

Results: There are many patents held by many parties internationally, with litigation over these patents ongoing in many countries.

Recontacting patients in clinical genetics services: recommendations of the European Society of Human Genetics.

Technological advances have increased the availability of genomic data in research and the clinic. If, over time, interpretation of the significance of the data changes, or new information becomes available, the question arises as to whether recontacting the patient and/or family is indicated. The Public and Professional Policy Committee of the European Society of Human Genetics (ESHG), together with research groups from the UK and the Netherlands, developed recommendations on recontacting which, after public consultation, have been endorsed by ESHG Board.

Data sharing policy design for consortia: challenges for sustainability.

The field of human genomics has led advances in the sharing of data with a view to facilitating translation of research into innovations for human health. This change in scientific practice has been implemented through new policy developed by many principal investigators, project managers and funders, which has ultimately led to new forms of practice and innovative governance models for data sharing. Here, we examine the development of the governance of data sharing in genomics, and explore some of the key challenges associated with the design and implementation of these policies.

Can I access my personal genome? The current legal position in the UK.

This paper discusses the nature of genomic information, and the moral arguments in support of an individual's right to access it. It analyses the legal avenues an individual might take to access their sequence information. The authors describe the policy implications in this area and conclude that, for now, the law appears to strike an appropriate balance, but new policy will need to be developed to address this issue.

Consent forms in genomics: the difference between law and practice.

Consent forms are the principal method for obtaining informed consent from biomedical research participants. The significance of these forms is increasing as more secondary research is undertaken on existing research samples and information, and samples are deposited in biobanks accessible to many researchers. We reviewed a selection of consent forms used in European Genome-Wide Association Studies (GWAS) and identified four common elements that were found in every consent form.

The impact of human gene patents on genetic testing in the United Kingdom.

Purpose: This article reports the results of an empirical study examining the impact of human gene patents on the development and delivery of genetic tests in the public sector in the United Kingdom.

Methods: Semi-structured qualitative interviews.

Results: The study found that, despite the potential for gene patents to have significant negative consequences for genetic testing, in fact, human gene patents have little or no impact on practice for those developing genetic tests in the public sector in the United Kingdom.

Identifiability, genomics and U.K. data protection law.

Analyses of individuals' genomes--their entire DNA sequence--have increased knowledge about the links between genetics and disease. Anticipated advances in 'next generation' DNA-sequencing techniques will see the routine research use of whole genomes, rather than distinct parts, within the next few years. The scientific benefits of genomic research are, however, accompanied by legal and ethical concerns.

Ethical implications of the use of whole genome methods in medical research.

The use of genome-wide association studies (GWAS) in medical research and the increased ability to share data give a new twist to some of the perennial ethical issues associated with genomic research. GWAS create particular challenges because they produce fine, detailed, genotype information at high resolution, and the results of more focused studies can potentially be used to determine genetic variation for a wide range of conditions and traits. The information from a GWA scan is derived from DNA that is a powerful personal identifier, and can provide information not just on the individual, but also on the individual's relatives, related groups, and populations.

Planning for translational research in genomics.

Translation of research findings into clinical practice is an important aspect of medical progress. Even for the early stages of genomics, research aiming to deepen understandings of underlying mechanisms of disease, questions about the ways in which such research ultimately can be useful in medical treatment and public health are of key importance. Whilst some research data may not apparently lend themselves to immediate clinical benefit, being aware of the issues surrounding translation at an early stage can enhance the delivery of the research to the clinic if a medical application is later found.

Data sharing in genomics--re-shaping scientific practice.

Funding bodies have recently introduced a requirement that data sharing must be a consideration of all funding applications in genomics. As with all new developments this condition has had an impact on scientific practice, particularly in the area of publishing and in the conduct of research. We discuss the challenges that must be addressed if the full benefits of data sharing, as envisaged by funders, are to be realized.