18 November 2012

DTC Genetics

Three perspectives on regulation of the direct-to-consumer (DTC) genetic testing market.

'Regulating the Use of Genetic Tests: Is Dutch Law an Example for Other Countries with Regard to DTC Genetic Testing?' by R.E. Van Hellemondt, A.C. Hendriks and M.H. Breuning in (2011) 3(1) Amsterdam Law Forum 14 notes that
Several European countries are considering the regulation of Direct-To-Consumer genetic tests via internet in order to protect the public. This paper addresses the question whether the Dutch Act on Population Screening, an internationally widely praised piece of legislation, could serve as an example for other European countries. While the Act adequately protects individuals against (potential) harmful screenings programmes, it falls short when it comes to offering protection against genetic tests offered to the public through the internet by commercial firms. The Act should therefore be amended, also to secure consistency with European legal standards. 
… a broad consensus exists among professionals in genetics that the implications of DTC genetic tests are far reaching and complex. Such testing should not be left to the free forces of the market, but should be accompanied by adequate information, and informed consent. There is – also in view of these concerns expressed by professionals – not only a need to revise the Dutch Act; it is above all important to elaborate on the emerging body of European legal standards applicable to DTC genetic screening. Offering genetic tests directly to individuals via internet raises complex legal questions that can not merely be answered by individual States. National measures can, moreover, easily be bypassed by making use of cross border constructions. Adequately protecting individuals against questionable testing kits therefore calls for international vigilance and comprehensive measures by the international community, in Europe to start with the Council of Europe and the European Union.
'Test at Your Own Risk: Your Genetic Report Card and the Direct-to-Consumer Duty to Secure Informed Consent' by Deepthy Kishore in (2010) 59(6) Emory Law Journal 1553 comments that
 On June 26, 2000, President Bill Clinton and Prime Minister Tony Blair announced that new gene sequencing techniques had accelerated the progress of the Human Genome Project; for the first time ever, scientists had completed a “rough draft” of the human genome. The announcement inspired a worldwide debate about cloning and genetic engineering, prompting both public curiosity and fierce debate about the nebulous science of predicting one’s lifespan and assessing the likelihood for developing disease. A host of companies, some of which market their services over the Internet, have since made genetic testing available directly to consumers. 
The emergence of direct-to-consumer (DTC) genetic testing raises important questions about how best to protect consumers from misinterpreting the meaning of their genetic makeup and has sparked discussion about how much and what kind of information a company should disclose to adequately warn consumers of the risks of undergoing genetic testing. Moreover, recent news events suggest that the Food and Drug Administration (FDA) will soon attempt to regulate DTC genetic testing: In May 2010, CVS drugstores and sixty thousand Walgreens drugstores suspended their plans to sell genetic test kits after the FDA announced that it would investigate DTC genetic testing companies. 
Selling access to individual genetic information has transposed the physician-patient relationship into a company-consumer context, calling for a novel examination of how consumer and patient protections overlap and where federal regulation ends and tort law begins. This Comment applies principles of products liability and informed consent to argue that tort liability, rather than greater regulation of genetic tests, is the best way to protect consumers of DTC genetic testing. It demonstrates that without professional assistance, consumers risk misinterpreting the meaning of their genetic test results and may even be driven to take drastic actions based on that information. Thus, this Comment asserts that where genetic testing services are marketed directly to consumers, the required level of disclosure should be the same as that under the doctrine of informed consent: Courts should impose a duty on companies engaged in DTC genetic testing to provide complete warnings, akin to the warnings physicians must provide patients in accordance with informed consent. The ultimate goal of the duty of disclosure proposed by this Comment is to protect and promote the autonomy of the consumer-patient.
'Genetic testing legislation in Western Europe - a fluctuating regulatory target' by Sirpa Soini in (2012) 3(2) Journal of Community Genetics 143–153  notes that
 Rapid developments of biomedical science have initiated different fora to take stand on the protection of human rights and human dignity. In front of the new genomic era with the completion of the Human Genome Project in 2003, a plethora of instruments addressing human genetic testing emerged, some looking suspiciously like legal acts. The notion of genetic exceptionalism was characteristic to the normative reactions in the legal acts, but it can be questioned how justified this is. Despite the critique on genetic exceptionalism, it is argued that in certain situations detection of a serious genetic anomaly may cause extra anxiety in a person tested, if the knowledge has a great significance also to family members. Regulative needs should depend on the context and purpose of the test. This review examines the legal framework governing the use of genetic tests in the clinical setting in Western Europe. Five countries have enacted genetic specific laws, and three have comprehensive provisions pertaining genetic testing in their biomedical legislation. Central provisions cover informed consent, autonomy and integrity of the person tested, further uses of tests results, quality requirements of the personnel and facilities involved. Moreover, contemporary challenges related to whole genome sequencing, direct-to-consumer genetic tests and insurance are briefly discussed. 
Soini concludes that
The expression ‘geneticisation’ has been used to describe a kind of a genetic hype, over-emphasis of genetic component in human life and identity based on the perception that genomic knowledge is exceptional, and determines the course of one’s life, diseases, energy levels, happiness and career. For instance, as Rothstein (2005) points out, a mutation or other impairment in DNA may rather be a symptom of a disease, instead of being a cause for it. Thus, environment along with social conditions have also a huge impact on how our genes express themselves. 
Many have argued against raising genetic data into stricter category of health data (Gostin and Hodge 1999; Laurie 2002; Rothstein 2005; Krajewska 2009). In an in-depth analysis, Gostin and Hodge (1999) argue that the hypothesis underlying genetic exceptionalism is flawed and it is not ethically and legally justified to distinct genetic data from other health data. Discrimination on other grounds may at least as devastating to a person. Clinical observations, lifestyle, family history and biometrics provide means to detect and predict a person’s current and future health. The basic rule about non-disclosure of sensitive personal data should apply here as well. Anna Krajewska has suggested that the term genetic information be replaced by the term biological information (Krajewska 2009 p. 25). Moreover, many acts stipulate the right-to-know and not-to-know about the results of genetic tests. The classic medical ethics and patient rights regimes govern the same issue, and I wonder why should there be a need for special provisions. If a person does not want to be informed of her medical condition, be it cancer diagnosis, HIV testing, or a genetic diagnosis, same approach and rules respecting the patient’s self-determination should apply. 
Despite the critique regarding genetic exceptionalism, I argue that in certain situations genetic data has elements superseding other health conditions, and may thus generate more anxiety in a person tested. This is the case particularly in serious clear conditions that have great significance for the close relatives. Indeed, the need to pay attention to the interests of the kin is acknowledged in many of the examined legislations, while some stick to strict confidentiality and deny all access of third parties to information without a consent of the person tested. 
Given the difficulty of defining the notion of ‘genetic testing’ and rapidly accumulating and sometimes also radically changing scientific knowledge, the regulatory task is not easy. Fear of eugenics is of course understandable cause for regulatory demands due to the rather recent eugenic policies in the beginning of twentieth century, and this history is clearly reflected in the regulation. However, claims of eugenics in the context of contemporary genetics seem to lack profound reasoning about the concept and its meaning (Harper 2008, p. 405-427). The purpose of today’s medical genetics is to alleviate individual suffering which is rather distinct from a coercive state policies targeted against certain groups and populations (WHO 2003, p. 10). 
Genetic testing should, as any other healthcare measures, be of appropriate quality and utility. Clinical validity and utility of the research findings shall be held important before consideration of their clinical application (PGH Foundation 2010). This would also need improvement of legislation in this field, as currently research is strictly regulated in Europe, but introduction of genetic tests into clinical practice lack sufficient control. However, some balancing will be needed as a strict scrutiny would raise costs and delay introduction of tests in practice (Cassiman 2011). Appropriate mechanisms for approval of tests for clinical purposes and quality assurance for laboratories and personnel should take place along with oversight mechanisms. Still, regulation should not be too detailed to be flexible in the course of scientific progress. The approach adopted in the Austrian, German and Swiss legislation to leave assessment of the state-of-the-art to an independent multidisciplinary committee established by law seems to provide an evolutionary and responsive mechanism in front of rapidly developing science. 
The role of the regulation can be seen as to facilitate practises and secure community interests by setting appropriate conditions and providing a structured framework for the activities in the field of genetics (Morgan and Yeung 2007, p. 4-7). Thus, it serves to provide public confidence. 
Asymmetry on information regarding genetic information both among lay people and general practitioners should be given a due regard. This goal is mentioned, for instance in the OECD Guidelines (2007). Use of a parliamentary normative process is likely to ensure the democratic decision making that reflects national attitudes and values. It could be enhanced by deliberative democracy by involving citizens to open discourse at the early stage of the normative process. If norms are developed outside the democratic process, for instance, in the expert instances, the process is not necessarily transparent, the values may not meet those of the citizens, and consequently, they may not be welcomed. Awareness raising and accurate information are crucial for maintaining public trust in science in general and genetics in particular. Approval of genetic applications is hence also a matter of reception.