Commercial speech in the realm of direct to consumer genetic testing. Are the current bans in the Spanish legal framework necessary and proportionate?
| Autor | Juan María Martínez Otero |
| Páginas | 177-196 |
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The rapid advance of genetics and technology has contributed to the spread of genetic testing services, which are increasingly reliable and af-fordable. The number of currently available genetic tests grows fast, including tests with clinical or diagnostic goals, pharmacogenetic tests, nutrigenomic tests, tests designed to reveal the familial bonds or ancestry of a person, or lifestyle tests, that can have a wide range of purposes, from seeking to identify the types of activities or skills in which the test subject is likely to be gifted, to determine the food that she could find more tasty, or the kind of physical exercise that suits her better.
Improvement in the cost-effectiveness of genetic testing has increased the community's interest, paving the way to a growing demand for these services1. Gradually, these tests are being requested by patients and individuáis willing to leam more about their status of health, their likelihood to develop a disease, their familial ancestry, etc. In this landscape, several for-profit companies have started to offer their services of genetic testing directly to the public, filling a gap that more than often is not covered by public health systems2.
Even though both at an intemational and national levéis the expansión of Direct-to-Consumers (DTC) genetic testing services has raised some
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concems, there is a noticeable lack of regulation in this arena, that produces uncertainty regarding the legal framework applicable to genetic testing and their advertising3.
This paper explores the right to commercial speech of the companies that offer DTC genetic tests in the market. In tune with a European trend, the Spanish regulatory framework imposes stringent bans to this form of communication, limiting the right of laboratories and genomic companies to advertise their services directly to the public. The following pages will dis-cuss whether these bans are necessary and proportional or not, attending to the rights and public interests they try to protect, and balancing them with the communicative rights of the companies and the customers.
Genetic testing can be defined as the analysis of biological samples of human origin, aiming at identifying the genetic characteristics of a person which are inherited or acquired during early prenatal development. When these services are targeted directly to consumers, without the involvement of a health-care professional in the process, they have been called Direct to Consumer (DTC) genetic tests. Other terms used to refer to these tests are "do-it-yourself" genetics, or "beyond-the-clinic" genomics4. Customers can have access to genetic testing in different ways: directly in the headquar-ters of the laboratory, purchasing tests over the counter in pharmacies, or purchasing them via Internet -on web pages of companies like 23andMe, Pathway Genomics or Color Genomics-5. In the latter two cases, test-takers usually send a saliva sample to the genomics company and receive their results via mail or uploaded onto an online account6. Depending on its
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purpose, a DTC test can analyse a single gene, a large number of them, or even the whole genome.
As was mentioned above, currently available genetic tests cover a wide range of purposes. For the sake of clarity, it is useful to distinguish between two main categories of tests: DTC genetic tests related with health care, and DTC genetic test not directly related with health care. Clinical7 and pharmacogenetic8 tests can be included in the first category, whereas fa-milial tests9, aptitude tests10 and lifestyle tests11 can be labelled as non-health related genetic tests. Nutrigenomic tests12 remain in a grey área, due to their connection with a healthy diet and its potential impact on health13. While health care related genetic testing have been regulated both at European and national level, other types of genetic tests lack a specific legal framework14.
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Freedom of speech and right to information are the most important com-munication rights. They have been recognised separately in article 20 of the Spanish Constitution15. The key factor to distinguish between these two rights is the nature of the message they protect. When the message is objec-tive, conveying objective data, it is a manifestation of the right to information. On the other hand, when the nature of the message is subjective, and it conveys an opinión, it is a manifestation of the freedom of speech. Regard-ing the right to information, the Spanish Constitution establishes a clear requirement in order to protect an objective message: its veracity.
It is also important to highlight that communication rights have a two-fold dimensión -active and passive- protecting both the emission and the reception of a message. Furthermore, the Constitutional case-law has stressed that the level of protection afforded to a concrete message de-pends upon its public interest. In this vein, the protection of a particular message will increase or decrease depending on the relevance of the message. Therefore, if the message relates to a matter of public interest, it will be considered "news", and will receive the highest protection against other rights potentially involved in the communication16. If the message lacks public interest, it could be more easily restricted to preserve other rights or interests with which the message could conflict.
Freedom of expression and the right to information are not absolute rights, and can be limited when they clash with other rights or public interests. In fact, Art. 20.4 of the Spanish Constitution includes a list of limits that communication rights should respect: other fundamental rights, hon-our, privacy, image rights, and the protection of minors. This list has been characterised as an open list by the Spanish Constitutional Court, which has admitted other limits that can be derived from the Constitution, such as
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national security, public health, or public order17. Nevertheless, and in order to be acceptable, every concrete limitation of Communications rights shouid meet strict standards estabiished both by the Spanish Constitutionai Court and the European Court of Human Rights (ECtHR). The three requisites that every restriction of the communication rights shouid fulfil are: legality -which means a specific previsión in a norm-, necessity in a democratic society, and proportionality18.
With the label commercial speech we refer to messages produced by companies in order to inform about their services and products and to influ-ence in the perceptions and consumption habits of potential customers. This form of communication falls under the protection of Communications rights, even though its nature is mainly commercial and normally biased. Insofar as commercial speech contains information or opinions that can be useful or interesting for consumers, there is a presumption of constitutionai protection in its favour. Therefore, to restrict any restriction of commercial speech shouid meet the aforementioned criteria required by the ECtHR and the Spanish Constitutionai Court: legality, necessity and proportionality.
Having clarified the concepts of DTC genetic tests, freedom of speech, right to information and commercial speech, we are in a better position to understand why some legal instruments have imposed restrictions on the communicative rights of the companies in the realm of genetic services, and to answer the question of whether these restrictions are fair and acceptable.
As has been stressed, communicative rights in their active dimensión protect the emission of messages, even if they have a commercial nature. Let us analyse now in more detail how commercial speech is guaranteed in the Spanish legal framework, in order to leam how this right protects commercial messages of DTC genetic testing companies.
The objectives of advertising and product promotion include building brand recognition and targeting potential consumers of the product. In the
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medical arena, a third goal can be added, consisting in raising awareness and understanding of diseases and products19.
The protection due to commercial speech and advertisement has been largely discussed, because of its partisan essence and its commercial in-terest. Notwithstanding the lack of neutrality of this form of speech, the ECtHR understands that since the message conveys information or opin-ions that are relevant for the consumers, it is a form of expression that should be protected by communication rights20. In the Spanish case, the Spanish Constitutional Court initially understood that the commercial speech should not be protected by the communication rights included in the Article 20 of the Spanish Constitution21. These rights, as understood by the TC, were aimed to protect speech when it addressed important matters and helped to shape public opinión. Taking into account that commercial speech did not meet these criteria, the Spanish Constitutional Court con-sidered that it deserved only the protection granted to the freedom of entrepreneurship (Art. 38 CE), a right with fewer guarantees in the Spanish Constitutional system of protection of rights. However, the Constitutional Court eventually change its...
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