Brazilian legal and bioethical approach about donation for research and patents of human body parts

Abstract

The aim of this paper is to explain why the Brazilian legal system does not accept commercialization or commodification of human body parts, including genes or cells. As a consequence, in Brazil, the donation of human body parts for research—including basic or translational—must be made altruistically. For the same reason, the Brazilian patent system cannot be applied to human parts, cells or genes. Here, we present a qualitative analysis of juridical, bioethical, and social reasoning related to the legal status of human body parts especially in biobanks, as well as a description of the Brazilian legal system for clarification. Our aim is to discuss the responsibility of researchers for making available the scientific information resulting from scientific research and biobank storage of human body parts and to ensure the free utilization of knowledge in human health research.

Introduction

The storage of human biospecimens and associated data in a “biobank” is a common practice in academic and commercial research, both in the fields of Biology and Medicine. Biobank is a polysemic word, generally means storage of human biospecimens. However, the applications of a biobank are potentially myriad, in both basic research and translational aspects of clinical research. There are also some areas of practice and research in which the storage of human biological material is obligatory, such as pathology, especially cancer pathology, and forensic genetics (Knoppers and Abdul-Rahman 2009).

In a broad view, the activities of biobanks encompass the creation of research networks, sharing stored specimens and/or associated information. optimizing research-related human and economic resources, and caring for and promoting the harmonized study of collections. Biobank activities also entail searching for both technical and environmental standards, encouraging the transfer of technology among research groups, using IT systems to organize and control the environments used for the storage of biological samples and the associated data, and establishing regulations and ethical guidelines for these activities. (Fernandes et al. 2012) (Dallari et al. 2015).

Biobank activity must be seen from a broad perspective as it encompasses public and private interests and is important not only for researchers but, indeed, for society at large, including government agencies in charge of public health policies. We need to consider the technical and ethical aspects of the storage of samples and the privacy of the associated information. Those aspects are the basis for the reliability of research results, focused in society best interest. (Rothstein and Knoppers 2015) (Knoppers and Abdul-Rahman 2009) (;(Martins-Costa and Fernandes 2012); (Fernandes et al. 2012.)

Scientists, scientific societies, and international organizations debate the policies related to biobank activities in their social, juridical, and ethical issues (ELSI), as well as in other technical aspects. Central to these discussions is the search for a harmonization, or at least an understanding, among different ethical, social, and legal perspectives, as well as best practices for the biobank’s governance. (Rothstein and Knoppers 2015); (Rothstein and Knoppers (2005).

This paper cannot address all aspects of biobank activity and will focus on basic and translational research. In order for biobanks to be organized in collecting human biospecimens and associated data, it must operate in accord with pre-established technical, ethical, and operational recommendations or rules (Ashton-Prolla et al. 2009).

In order to build an international consensus on the ethical, legal, and social issues (ELSI) related to the functions of a biobank in basic and translational research, we must look to national legal systems to find the principles and rules that underlie the framework of each country’s biobank(s) and that must come together to enable the integration of these frameworks into a common system. One central issue is to study the legal status of donated human biospecimens, organs, and personal data held within a biobank.

The donor or the research subject has to donate voluntarily, through a process of informed consent agreed directly by the donor or through their legal representative; without this, the biobank would be acting unethically and, in some countries, also illegally.

Our aim is to discuss the legal status of donated human body parts in the Brazilian juridical system and to ask why Brazil does not allow a patent on donated human biological material.

In jurisprudential and bioethical terms, we believe that addressing these aims will help us to develop guidance for the operation of human research biobanks. In order to do that, we will discuss three pivotal arguments: (1) In Brazil, the donation of human biospecimens has to be performed as an altruistic act of human solidarity, aiming at a common benefit for humankind. (2) In Brazil, the concept of “donation” is distinct from that of a “donation contract” (it is important to say that even the word donation, when used in national and international documents relating to biobanks, does not have a clear meaning). (3) The Brazilian patent law does not allow the patenting of human body parts, cells, or genes based on the legal principle of not commodifying the human body or its constituent parts.

Donation human biospecimens in Brazilian legal system: humankind’s common benefit

The Brazilian legal system is subject to the Constitution of the Federal Republic of Brazil (1988) and is characterized as a Civil Law system, which is an important legal source or normative model. Moreover, legal norms are formulated along both broad and specific areas of application. For example, in the Brazilian Civil Code, Law 10,104/2002 is a general law that organizes the actions of citizens in civil life; on the other hand, Law 8080/1990 is more specific, establishing the conditions for the promotion, protection, and recovery of health, and the organization and operation of the corresponding services and other measures.

Thus, as a Civil Law country, Brazil’s legal system operates as a normative mosaic where the general rules and Acts can be used separately or together according to their scope and the expertise and competence required to address particular problems or legal issues. The system as a whole, and any regulatory gaps, must be addressed through other sources of law, such as jurisprudence, human legal transactions, and those social customs that are recognized by law. It is also necessary to take into consideration international treaties examined by Brazilian legislators and signed by the Brazilian government.

The Brazilian legal system in general follows a principle opposed to the commodification of the human body. This normative model is expressed in legal terms and its moral reasoning is based on the recognition that respect for human beings and protection of human dignity are the central aspects of the normative system. The Constitution of the Federal Republic of Brazil (1988) is based on the principle of respect for human dignity (Article 1^o), guarantees “fundamental rights” and respect for human integrity (Article 5^o) and the Article 199, § 4, says: “The law shall provide the conditions and requirements which facilitate the removal of organs, tissues and human substances for transplantation, research and treatment, as well as the collection, processing and transfusion of blood and blood products, and prohibits all kinds of commercialization”.

It is important to explain what “fundamental rights” means in the system of Brazilian constitutional law. It means that the rights connected with human personal existence—life, liberty, equality, security, and property—are strongly guaranteed by the Constitution. Human integrity in Article 5^o and what it specifies in detail constitute a fundamental clause, termed “Clause Petra.” This clause guarantees immutability of these rights, in other words, the Article 5^o cannot be diminished, suppressed, or changed to the disadvantage of people by any normative act, even by a constitutional amendment, and it is considered the core of the whole normative system.

As mentioned above, Brazilian law in general, in respect to Constitutional norms, adopts the principle of “no commodification” of the human body. This principal model is specified further in various legal Acts.

The Brazilian Civil Code, Law 10.104/2002, general part from Article 11 to 21, establishes the obligation to respect the human person and the protection of personal rights. It recognizes the human person as the source of all value in the legal system and thereby protects his/her personhood. The rights of the human person, further specified in Article 5^o and Article 199, § 4 of the Brazilian Constitution, encompass a broader concept that aims to guarantee human existence in its triple sphere: the biological, moral, and social. In the biological sphere, the Civil Code protects both the physical integrity of the person and the respect for self-determination regarding, for example, organ donation (Article 13), the decision whether to dispose of one’s body after death for scientific purposes (Article 14), the refusal of medical treatment or surgical intervention in standard medical treatment (excepting emergency scenarios) (Artigo15) (Brazil 2002).

Similarly, the Organ Transplant Acts, 9434/1997 and 10211/ 2001 (Article 9), state that donation of parts of the human body, tissues, and organs for therapeutic purposes or for therapeutic transplantation must be performed as acts of altruism (Brazil, Law 9.434/1997). Other normative statements assert the same principle, thus the Blood Donation Act, 1.075 /1950, states that donation must be voluntary and unpaid. Further, the Biosafety Act, 11,105/2005 (Article 6°, section VII), expressly prohibits the use of the human body for commercial purposes, marketing, patenting, and patent’s licensing restrictions (Brazil 2005).

The Resolution 441/2011 from the National Heath Council, submitted to Brazilian Ministry of Heath, providing guidelines and recommendations for biobank activity, states that the collection, storage, use, and disposal of human biological material has to be performed as a voluntary donation. The donor’s human rights must be protected, and their fundamental freedoms and human dignity must be respected.

The moral reasoning used to justify the Brazilian principle of “no commodification” (Scheper-Hughes and Wacquant 2006) of the human body is the intention to value and protect human beings, to respect human rights and humanitarian principles, and to oppose at all levels the transformation of human beings into commercial transaction object.

Thus, in Brazil, the donation of body parts must be entirely free and subject to voluntary consent. It is understood that the donation of human biological material (such as organs, blood, cells, genes) has its motivation in altruism and solidarity, in support of scientific progress in health care. (Civil Code 2002; HCPA 2009; CNS/CONEP 2011).

Actions of altruism and solidarity, in Brazilian law, entail a moral justification. So, altruism and solidarity have to be understood as fundamentally moral and social concepts, in their generic sense, including social and political connections, such as respect for the personal freedom to donate without an economic motivation and with a legally permitted purpose, such as the promotion of medical research in the pursuit of a common good.

Altruism and solidarity are seen as providing the justification for organ donation from the perspective also of bioethics. There are some conceptual distinction between altruism and solidarity, despite the fact that the bioethics literature does not provide a unanimous understanding of those words (Prainsack and Buyx 2012; p. 346).

Adopting the distinction between altruism and solidarity made by Prainsack and Buyx (2012), we quote:

“altruism is a more general attitude towards (all) others, whereas solidarity comprises concrete practices within a community of people who are sharing certain things in common. (…) That is solidarity as a recognition of similarity with one (or more) other people in one relevant respect can take many forms: It entails the awareness of being associated – by choice, by ‘fate’, or other circumstances, with others.” (Prainsack, B. and Buyx, A.; p. 346, 2012)

Important also is referring Titmuss classic book The Gift Relationship: from Human Blood to Social Policy, first published in 1970 and reprint 1997. He showed empirically that blood donation altruistically (desire to help others, “creatively altruism) and voluntarily (free of self economic interest in benefit), practiced system in Britain, is more successful and safe compared to paid donor’s system, as done in the United States of America (USA). He also demonstrated that altruism and solidarity are the most effective social way to stimulate donation of human body parts, rejecting economic prevalence as a motivation to organ donation and for avoiding human exploitation and commercialization. Titmuss’ ideas influenced and still help to protect and value the principle of non-market for donation of human body parts and a welfare heath system (Titmuss 1997).

We can also say that the (free) market, which is able to impose efficiency and self-regulation, is unable to drive the regulation of many areas of human life and society, precisely because these values are morally inadequate and unable to recognize the basic values of human coexistence.

Similarly, Michael Sandel questions the normative acceptance and moral adequacy of the use of market rules to justify and stimulate the market in human body parts, whether nationally within the USA or internationally. The USA accepts the commercialization of human body parts and can influence other countries, because of its political and economical power. According to Sandel: “We have drifted from having a market economy, to being a market society.” (What Money Can’t Buy: The Moral Limits of Markets, 2015) (Sandel 2015).

Nancy Scheper-Hughes also question the commodification of body parts, saying that “in the academy “the body” is generally treated as a text or a trope or as a metaphor that is good to think with, in the larger society and in the global economy “the body” is generally viewed and treated as an object, albeit a highly fetishized one, and as a “commodity” that can be bartered, sold or stolen in divisible and alienable parts.”

The donation of human body parts within a market framework—the commodification of body parts—is a highly questionable view, challenged by fundamental rights reasoning and the human rights perspective adopted by the Universal Declaration on Bioethics and Human Rights (2005).

In this sense, the Opinion of Advocate General of the Court of Justice of the European Union, Yves Bot, in the Case-law Oliver Brüstle v. Greenpeace, on 10th March 2011, regarding the interpretation of the Directive 98/44 as to patent or nor human embryo, contributes. The Opinion considers the proposition of the Directive 98/44, which is to establish a community legal framework for inventions related to living matter and to integrate ethical considerations so as to prevent the economic functioning of the market giving rise to competition at the cost of sacrificing the fundamental values of the Union, and conclude against the patent of human embryo. We highlight the follow two concluded topics of this Opinion (2011):

An invention must be excluded from patentability where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos.

The exception to the non-patentability of uses of human embryos for industrial or commercial purposes concerns only inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it.

We believe that the Brazilian legal system appropriately restricts the role of the market in human body parts. We also agree with the Brazilian legal objection to the use of contract law and other legal instruments appropriate to patrimonial or economic legal transactions in relation to human body parts. On the contrary, a donation of human organs has to be altruistic and an expression of solidarity.

Consequently, in a Brazilian context, the parts of the human body have a guaranteed legal protection as an intrinsic part of the human rights of each individual and this prohibits their appropriation and/or commercialization and the commodification of human biological materials, even ownership through patents.

The “donation of human body parts for research” in a Brazilian legal context

As a preliminary, it is important to clarify that the Brazilian Civil law system establishes a different meaning to, and different legal effects of, the terms “donation” and “donation contract” (Civil Code 2002) (Organ Transplant Acts, 9434/1997 and 1,0211/2001). So, it is important to clarify these differences before dealing with the donation of human biological material for biobank activity in Brazil.

The use of the term “donation,” both in the law and in common sense, can easily be mistaken for a contractual transaction, especially with a “contract of donation.” This misunderstanding may have legal consequences, as we would like to explain (Martins-Costa and Fernandes 2012).

The donation of human body parts is not permitted to be part of a commercial legal transaction or contract of donation. Therefore, the donation of human biological parts is considered to be a legal transaction of an existential nature. In legal terms, a legal transaction of an existential nature cannot involve any assets or goods which can be commercialized—like a house, a car, food, money, and intellectual property rights—and in this kind of legal transaction, it is not permitted for there to be any economic operations involving the circulation of wealth.

In the Brazilian Civil Codes, “legal transaction” is a very broad juridical concept, which can cover many human acts with a patrimonial finality such as “donation contract,” or an existential finality, such as “donation of body parts for an organ transplant.” To understand the Brazilian juridical system in that aspect, we shall first explain the concept of “contract” in the legal sense (Flume 1998), including a “contract of donation.”

Like all legal concepts, the word “contract” refers to an abstraction, a creation of jurisprudence: in this particular case, the concept contains and categorizes different contractual types united under one jurisprudential form and considered as being the vehicle of a number of functions which have been, historically and culturally, tied to specific and diverse but related society-structuring processes of production, experience, and power (Martins-Costa 2008).

The modern notion of a contract, involving a jurisprudential concept, has been used to refer to an exchange of consents—an exchange of “manifestations of will” (or promises) built upon an ancient notion of contract as a synallagma, or an exchange of things or behaviors which impose an obligation for all parts involved (Ghestin J. 2000). In the beginning of the twentieth century, another notion was proposed: contract as a specific type of legal transaction. The concept of legal transaction is the key concept in some Civil Codes, such as the German Civil Code—BGB, Bürgerliches Gesetzbuch (1900); the Italian Civil Code (1942), and the Brazilian Civil Code (2002). In German, this concept is called Rechtsgeschäft; in Italy Negozio Giuridico; (1942) and in Brazil is Negócio Jurídico (Flume 1998); (Mello 2007); (Pontes De Miranda 1954); (Azevedo 1986); (Menezes Cordeiro 2000).

In Brazil, “contract” is understood as a narrowed concept of legal transaction. The concept of contracts is understood as a kind of legal transaction with two sides. The structural side defined by transactions that are formed through the encounter of one or more transactional declarations that combine to establish a mutual regulation of interests (i.e., the agreement) and the functional element, which justified the ends and the reason of the contract: to formalize economic operations of wealth circulation. (Mota Pinto 1995); (Gomes 2008).

In Brazil, the main scope of contracts is, therefore, the field of patrimonial relations, and their proper function is to formalize economic operations of wealth circulation, i.e., operations through which goods circulate between one patrimony and another. This concept is so widely applicable that contracts are considered, per se, sufficient reason for the circulation of wealth between patrimonies, configuring the jurisprudential structure par excellence that justifies patrimonial attribution. (Martins-Costa and Fernandes 2012).

To quote Orlando Gomes, one of the first Brazilian scholars to focus on the functional profile of contracts, “the primordial function of contracts is, therefore, to propitiate the circulation of wealth from one patrimony to another, provided this transference occurs through licit, voluntary acts”. Gomes proposes a list of economic functions provided by contracts, apart from the promotion of circulation of wealth, such as collaboration with economic interest, risk prevention, conservation, cautionary support, conflict prevention, conflict control, credit concession, and the constitution of tenure or collateral rights in rem. (Gomes 2008).

The essential conceptual marker in Brazilian legal system is that contracts are economic operations of wealth circulation, which happen by voluntary human conscious acts between two or more agents. We say an “economic operation” has occurred whenever there is actual or potential circulation of wealth between different patrimonies. “Wealth” here might be defined as all goods and utilities that can be economically quantified, whether they are “things” in the strict sense or “immaterial things.” (Roppo 1988).

Taking into consideration that, in the Brazilian legal system, a contract must have an economic function and must be the legal instrument for the circulation of wealth from one patrimony to another, we assume that all donation contracts have an economic interest. In reality, a donation contract is a bilateral arrangement and it happens when one sphere (a person or persons) freely, beneficially and with conscious will, transfer part of his/her/their patrimony to the other sphere (another person or persons).

On the other hand, the act of donation of human biological material or biospecimens for biobanking is not a contract, despite the fact that it also has a structural side, because as an agreement, it does not have an economical functional element since it does not entail a circulation of wealth.

The Ministry of Health of Brazil, through Ministerial Ordinance 2201/2011, and by the National Health Council, through Resolution 466/2001, was intended to develop a national guideline for biorepositories and biobanks of human biological material for research purpose. In this Resolution, there is a conceptual distinction between biorepositories and biobanks. Biorepositories are considered collection of human biological material, collected and stored during the execution of a specific research project, under a management of a researcher. Biobanks are an organized collection of human biological material and associated information, collected and stored for diverse and collaborative research purposes, under management and responsibility of an institution. Both have to be organized according to pre-defined technical, ethical, and operational regulations and standards and with no commercial purpose (Brasil, CNS/CONEP 2011 and Brasil, MS 2011).

Unfortunately, disregarding the legal concepts the Ministry of Health of Brazil used in the Ministerial Ordinance 2201/2011 and in the Resolution 466/2001 the word “assignment” (cessão in Portuguese) instead of “donation” of human biological material. The meaning of the word “assignment” in the Brazilian legal system, as in most legal systems, is related to legal transactions with economic and patrimonial character or contractual obligations, for example, credit transfers; in any case, an assignment is different from the word donation (Brasil, CNS/CONEP 2011 and Brasil, MS 2011) (Lenk et al. 2011).

Under Brazilian law, the donation of human biological material to a biobank, for its purposes, must be an act of altruism and solidarity and performed as a free and voluntary act to support scientific, medical research, as we explain above. Such a “donation” of human biological material or biospecimens must be considered as an existential legal transaction, resulting from an agreement struck between two or more persons about a non-patrimonial object. It is a transaction which presupposes a shared objective, a manifestation of the will of both parties.

The act of donation of human biological parts and material is therefore a bilateral act, because both spheres—donor and recipients—are affected: the donor gives his biological material available to storage in a biobank subject to certain conditions as to the purposes of the biobank and the recipients (the researchers and the institution) assume a series of related duties, among others, the obligation to obtain the informed consent of the person and to protect his or her privacy (Martins-Costa and Fernandes 2012).

The Brazilian patent system does not permit the patenting of human body parts, cells, or genes

Intellectual property is a legal institution, constitutionally protected and located in the area of Private Law. Among the various forms of intellectual property, we highlight in this paper the function of patents.

In the Brazilian legal system of patents, rights are generated in favor of the inventor upon the legal registration of their invention when it is recognized by a national Patent Office (in Brazil this is the Instituto Nacional de Propriedade Intelectual-INPI). The patent’s owner can exploit the economic benefits of the invention by him/herself or through a license granted to third parties and the consequent receipt of royalties, for a period determined by the law, limited to a period of 15 or 20 years, depending on the type of patent (Brazil 1996).

A patent is an intangible property regulated and limited by its social function. In this sense, the great Brazilian jurist Pontes de Miranda states: “the right attendeing the notion of thing is not naturalistic, or physical, but is an economic-social concept, what the human mind invents, creating economic and social value (Pontes De Miranda 1954).

Thus, the rationale behind the patent system in Brazil, and in particular behind the exclusion of patents relating to human body parts, can be accounted for by considering three main aspects:

1. The Brazilian Patent Law considers patents as a form of property, which explains why human body parts cannot be patented, because they can neither be appropriated nor be considered an object or a product.

2. Patents on human body parts do not respect the essential criteria for anything patentable, i.e., novelty, being the product of a non-obvious inventive step and not merely a discovery, and the principle of alternativeness. The principle of alternativeness guides the patent system against the creation of monopolies as they hinder developments in the field or the industry involved. This principle is based on the idea that a patent cannot prevent other people from reaching the same results as those of the patented invention but by other means (Carvalho 2004).

3. Patents on human body parts would disregard legal principles of morality and public interest. Let us develop each of these aspects mentioned.

Taking these three premises, let us develop their arguments.

1. Brazilian Patent Law considers patents as a form of property, and therefore human body parts cannot be patented since the Brazilian Civil law does not accept property rights in human body parts. On the contrary, human body parts have legal protection through the human rights of each individual person (Articles 11 to 21 Civil Brazilian Code) based on the principle of human dignity and cannot be subject to a legal transaction for economic benefits (Brazil 2002).

In fact, there is an explicit prohibition of patenting human body parts in the Law of Brazilian Intellectual Property, Act 9.279/1996, Article 10, IX, and Article 18, III. Also, the Article 10, IX prohibits the patenting of human biological material and parts or of biological material found in nature as part of living beings. That prohibition even covers biological material after it has been isolated from nature, as is (in contrast) allowed under regulations in force in the Patent Offices of the USA and the European Union. Under Brazilian law, it is prohibited to patent the genome or germplasm of any natural living being or any natural biological process. (Brazil 1996) Furthermore, Article 18 of the Brazilian Intellectual Property Law determines which products are non-patentable, among them, those opposed to morals, traditional habits and security, social order, and public health, and which products involve all or part of living beings that are not a mere discovery (Brazil 1996).

However, Act 9.279/1996 of the same Article 18 makes an exception to the rule when talking about microorganisms. Thus, the Brazilian Law allows patenting of transgenic microorganisms since the invention fulfills the three requirements for a legal patent: novelty, inventive activity, and industrial applicability (Brazil 1996).

• 2.The lack of technical requirements for patenting human body parts or biological material is based on the fact that it does not respect the legal patent criteria of novelty, inventive activity, and the principle of alternativeness.

We believed that patents related to human body part area have not only failed to provide an incentive to innovation but have actually become an obstacle to generating new developments in medical science. We may consider the example of the American experience regarding both stem cells and gene patenting in relation to facilitating access to information and promoting progress in relevant fields of research and development (Fernandes 2012).

The USA was a pioneer in admitting that discoveries—even those previously existing in nature—could be patented, abandoning the so-called product-of-nature doctrine, which prohibits the patenting of biological material from human beings or animals. The position of the USA on the criteria for patenting has considered the degree of human intellectual effort and the creativity needed to develop an invention or a discovery, including the transformation of something existing in nature and compatible with industrial production (USPTO. 2007).

The American legislation considers as patentable an invention or discovery that complies with the following requirements: the invention cannot be obvious, it should be new, and it should be useful for industrial application. The fact that utility is the criteria being replaced with inventive activity from other legislations is the reason why both criteria—utility or inventive activity—are described in the Agreement on aspects of Intellectual Property Rights (TRIPS), Article 2, by the World Trade Organization (WTO). The “utility” criteria has practical impacts on the interpretation of inventions and discoveries, since the relevant point in the American legislation is the utility the patent will have in the industry and not necessarily the inventiveness or its moral justification.

The American patent office (USPTO) grants patents to in nature stem cell lineages, such as the patents of WARF—Wisconsin Alumni Research Foundation—and Geron Corporation. Today, in the USA, patents of adult and embryonic stem cell products or processes are allowed without having, at first, any type of legal restriction (Christie 2003); (Bagley 2003).

In particular, for researchers working with human embryonic stem cells, the American reality is made much more complex for several reasons. First, there are restrictions on public funding for research using human embryonic stem cells. Furthermore, although the patentability of stem cells might be thought to promote research, in fact, it serves to block access to the use of such cells (Gratton 2002a); (2002b); (Fernandes 2012).

In this sense, Carvalho states that it is not possible to distinguish between inventions that are research tools and inventions that may become “real” industrial products, as their nature is not changed as a result of their utility. To illustrate that, the author uses “a microscope”: “The microscope is a research tool and a commercial article. If a scientist uses it with the intention of studying something else though using it as a tool, the scientist will not be infringing the patent, as he/she would have the researcher exemption. However, if the scientist uses it as a form of distinct investigation to study the “microscope” itself without a license, such activity would be considered as a patent infringement.” (Carvalho 2004).

The principle of alternativeness is presented as the guideline of a patent function, which is the democratization of knowledge, aiming at the production and technological development of licit and industrially useful inventions, and for this reason, this system does not protect ideas or laws of nature.

So, the principle of alternativeness was delimited with discussions regarding patents of “products of nature.” It is inherent in the patent system to share information about the patented invention; this sharing aims to develop and increase the sector involved in patents, because the monopoly is contrary to the patent system, as Carvalho argues:

But why are manifestations of laws of nature free to all men? The reason is that effective operation of the patent system depends on the limited grant of patents. Patents should be granted only for those new, non-obvious and useful inventions or discoveries that provide alternatives to existing technology that can be alter-invented.

(…)

Under the condition of alternativeness, as articulated by the Supreme Court, patents cannot be granted on ideas or on knowledge that other persons cannot otherwise use. A patent grants exclusive rights in a certain invention, but that exclusivity may not impede other persons from using the same natural principle or material by different means from those claimed in the patent(Carvalho 2004).

However, even in the USA, the allowance to patentability of human biological material is being reexamined through discussions surrounding the Association for Molecular Pathology v. Myriad Genetics case. The central question around this case is to discuss whether patents related to human body parts could be challenged on either moral or technical grounds. The Supreme Court decision invalidated the Myriad Genetics company’s patents on BRCA1 and BRCA2 genes. The case addressed the validity of patents, which had ensured a monopoly, for the Myriad Genetics company over the market for the genetic testing of the BRCA1 and BRCA2 genes.

The American Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics ended the patent-based monopoly held by Myriad Genetics in the market for testing the BRCA 1 and BRCA2 genes in 2013. This case focused, among other reasons, on the lack of novelty in the patent and the incompatibility of these patents regarding the free access of other researchers to technologies and research tools that are essential to progress in medicine (Miller 2003; Lee 2005; Plas 2006a, 2006b; Carvalho 2004; Conley et al. 2014; United States District Court 2010; Fernandes 2012).

The way that Myriad Genetics exploited its patents impacted on people’s access to genetic testing and on the accuracy of interpretation of genetic test results for patients and diminished the value of research by others involving the BRCA1 and BRCA2 genes. The criticism of Myriad Genetics over its patents highlighted the discussion on the legal validity of gene patenting and on its ethics. The company’s patent increased the dissatisfaction of patients, hospitals, physicians, research institutes, academic institutions, researchers, non-commercial and nonprofit laboratories, and governments, which aroused public concern about the use and validity of human gene patents (Baldwin, Cook-Deegan, 2013, p. 6) (Fernandes 2012).

In contrast, Brazil has been recognized worldwide for its adoption of a balanced position in the promotion of intellectual property rights, as we can illustrate with HIV/AIDS medication at the international system of World Trade Organization (WTO), TRIPs system, and for maintaining in the legislation a clear prohibition to the patenting of human biological material and human body parts, among other things (Fernandes 2012).

In Brazil, starting from the premise that the patent will be registrable when the inventive step and the principle of alternativeness are both in compliance with the rules and legal principles of patenting, the technical nature of the invention is critical to its characterization. Never forgetting that an invention is a technical solution to a technical problem, it can be seen that a patent cannot be awarded if it has human biological material as its central object (Carvalho 2004).

• 3.The inapplicability of patenting to human biological material and human body parts is related to the legal principles of morality and public interest. Patents involving human body parts raise issues of ethical and moral concerns for researchers, civil authorities, academics, patent officers, international governmental and non-governmental organizations, and the community in general.

Among other examples, The European Group on Ethics in Science and New Technologies to the European Commission elaborated an opinion, N° 16, and a study “On ethical aspects of patenting inventions involving human stem cells” (2002); the Nuffield Council on Bioethics has published a study called “The ethics of patenting DNA” ( 2002); the Danish Council of Ethics issued a “Report on the ethics of patenting human genes and stem cells” (2004); the United Nations Educational, Scientific and Cultural Organization (UNESCO) formally announced the Universal Declaration on Bioethics and Human Rights (2005) and The Court of Justice of the European Union (CURIA), Case-law Oliver Brüstle v. Greenpeace ( 2011). (Bioethics 2002); (United Nations. 2001); (Bot, Yves, Opinion of Advocate General, 2011) (Judgement, CURIA, Case-law Oliver Brüstle v. Greenpeace, 2011).

Following the same path, the World Health Organization (WHO) created the Commission on Public Health Innovation and Intellectual Property Rights which issued a report on this theme in 2006 (WHO 2006). This,report recognized that researchers in the USA in academia and in government and non-profit organizations have attested the difficulties created by this intellectual property policy for the development of research, in particular those involving research tools, which impede access to materials such as cell lines and genes (United Nations 2001); (Nozaradan 2007).

Similarly, the Nuffield Council on Bioethics, when it assumed a position on the ethics of the patenting of DNA sequences, recognized the need to redefine the patent system in the area of DNA sequences, as it recognized the inappropriate and damaging consequences of patents awarded on weak or spurious grounds (Nuffield Council on Bioethics 2002; Nozaradan 2007).

Also, some authors are arguing the inadequacy of patents on the human body. Richard Gold indicates that the holder of a patent may prevent others from using, producing, selling, or importing an invention (Gold 1999, 2002). However, it may be impossible to justify the appropriation of human body parts based on an analytical definition of property. On the contrary, the constraints on patents have to be designed by each group in society to justify its interest in developing (or not) a legal system of appropriation of human body parts through patents for social, political, and economic reasons.

The public interest, through the recognition that patents may legitimately be restricted by considerations of morality and social order, has been one of the most frequently cited reasons for restricting the patenting of inventions or discoveries in biotechnology and public health, such as those involving genes and human stem cells. The basis underlying the system of patenting is the promotion of the public interest, operationalized through the knowledge dissemination theory, i.e., describing the invention sufficiently clearly to ensure that society can measure its value and properly allocate resources to promote the new technology but granting a period of monopoly to the commercial exploitation of the patent to the inventor, although with limitations to its practice, preventing abuse of these monopoly rights (Carvalho 2004); (Nozaradan 2007); (United Nations. 2001).

In the national and international systems of patents, the public interest appears, according to Overwalle, as a “mosaic of general interest,” considering the social order, good manners, public security, consumer protection, public health protection, life protection, environment protection, economic development protection, industrial and commercial property protection, democratization of the access to knowledge, education, etc. (Overwalle 2001).

The interdisciplinarity of these interests is also inherent within the concept of public interest, as many other concepts, except the juridical ones, should constitute its content and reach, in any particular, concrete situation, an appropriate balance between the private and the collective.

Final considerations

Brazil does not allow the patenting of human body parts, cells, or genes as these would be contrary to the Constitutional Law and Brazilian Civil Law for the protection of human beings and their civil rights. Thus, in Brazil, the act of donating human biological material is legally considered an existential legal transaction and it has to be performed as an act of altruism and solidarity, aiming at humankind’s common benefit.

We can account for this qualification for a “donation” referring to human biological material or biospecimens. Although the structural element—the agreement—is present, the functional element is lacking, because in Brazilian legal system, it is not permitted to commercialize or to commodify human body parts, genes, or cells. There is no possibility of economic quantification or any kind of circulation of wealth between donors and recipients. It is, therefore, an existential legal transaction and not a “donation contract,” because all contracts in the Brazilian legal system have to promote a wealth circulation. That is why we suggest the change of the word assignment (cessão) in the Brazilian regulation of human biobank activity (Brasil, CNS/CONEP 2011; Brasil, MS 2011).

In the Brazilian legal system, the act of donation is not a contract, because human biological material is not permitted to be an object of any kind of economic transaction, which means that the human biological material and corresponding data stored in a human biobank cannot, for example, be sold.

Taking that into consideration, we can conclude that material storage in a biobank has to be chosen freely by the donor since human body parts or biological materials are not considered a “thing.” Likewise, this material cannot be appropriated by the researcher or management committee responsible for the administration of the biobank’s activity. Furthermore, the biobank manager is not permitted to transfer to, or to share with, unauthorized third parties or allow the destruction of the human biological material stored and the corresponding data without the knowledge and consent of the donor or his/her representative, which may be obtained prior to donation or during the storage period.

In this scenario, Brazilian Intellectual Property Law prohibits the patenting of human body parts, cells, or genes for they fail to meet the criteria for valid patenting of novelty, inventiveness, and utility, besides being contrary to the principle of alternativeness and the public interest. Our patent system is functional and is based on a dissemination theory—the democratization of the access to knowledge and education.

The donation of human biological material involves a simple declaration, which must be made autonomously and altruistically by the donor with a specific goal, previously identified by the biobank. The focus has to be on social responsibility, expressed through the commitment to the progress of science and technology in a spirit of cooperation and the dissemination of scientific information as an incentive to the free utilization of knowledge.

We believe that Brazil has adopted the appropriate legal stance against the commodification of the human body and its parts. The UN expresses this position to reinforce respect for human dignity and, in accordance with international declarations and reports and, specifically, in order to promote the protection of the human personality as an essential value and a fundamental human right.

Finally, this approach counters any processes for the commercialization of the human body or its parts in research with humans in the context of biobank activity. This values a very important precept for all humanity: avoid exploitation and conflicts of interest in the recognition and implementation of freedom, autonomy, and respect for human beings.

Compliance with ethical standards

The research does not involve human participants, so informed consent is not required, and the research does not involve animals.

Conflict of interest

The authors declare that there have no conflicts of interest.