Summary of the Opinion

The Opinion of the Reflection Group on Bioethics on Synthetic Biology is divided into three chapters, followed by a conclusion. The first chapter, titled “A Rapidly Expanding Domain,” introduces and describes synbio; the second, “Objections in Principle or A Call to Responsibility?” discusses various ethical issues, under three subheadings: “A rebellion against the sovereignty of God?;” “An arbitrary manipulation of life?;” and “An urgent appeal for responsibility.” The third, “An Essential Framework for Practices,” deals with the issues of safety and security, international trade and justice, patents, public information and dialogue between science and society, and application to human beings. In constructing its arguments, the Opinion quotes liberally from relevant Catholic Church teachings and also from several EU and other government-level documents; it applies conclusions from both, along with more general ethical approaches, to the issue of synbio ethics. The document is short; it does not compare, in terms of breadth and depth, with the various other major reports (government, charitable, private) currently in circulation.

The Opinion begins, in chapter 1, by attempting to define synbio. It quotes from a report by the European Group on Ethics in Science and New Technologies in the European Commission (EGE), which is an advisory group to the European Commission. This report, Ethics of Synthetic Biology, ^{Footnote 7} states that synbio is difficult to define, and that any definition may change over time. ^{Footnote 8} Neverthless, the EGE then describes what a definition of synbio should include, and the COMECE Opinion adopts that, quoting from the EGE that synbio is the attempt to create artificial life forms; or to re-engineer existing lifeforms. ^{Footnote 9} Also, any definition should include the research areas of biological toolkits; attempts to design minimal genomes, cells, or organisms; and building biological systems that are partly or totally artificial/synthetic. ^{Footnote 10} The Opinion also notes that synbio is primarily an engineering discipline, using the techniques of disciplines such as computer science and mathematical modelling, applied to biology, to design synthetic parts or organisms. On this it quotes, for emphasis, from another definition, that of the European research consortium Synbiology: “… [synbio] is determined on the intentional design of artificial biological systems, rather than on the understanding of natural biology.” ^{Footnote 11} COMECE’s authors then briefly discuss a number of topics in synbio research: top down versus bottom up approaches to building synbio systems, Synthia, and minimal cells. ^{Footnote 12} This introductory section is quite short; it lacks detail and does not mention several important research areas. It gives an “impressionistic” (in the popular sense of the word) overview of synbio, rather than an authoritative account.

The Opinion then explains some potential and current uses of synbio, giving a few examples, in areas such as agriculture, the environment, health, energy, and materials. ^{Footnote 13} It quotes from France’s Parliamentary Office for Evaluation of Scientific and Technological Options (OPECST) report, Les Enjeux de la Biologie de Synthèse [Issues in Synthetic Biology], which observes that synbio may generate a second industrial revolution, affecting areas such as medicine, agriculture, the environment, energy, and industry, having the potential to cure disease and help provide solutions to problems such as climate change. It warns, too, against “overhyped promises.” ^{Footnote 14}

COMECE’s authors observe that synbio’s progress is likely to depend on a variety of factors. The feasibility of the science is one, obviously, as is risk assessment, but other factors may influence decisions about the field. These may include the outcomes of philosophical, ethical, and religious debates, as well as the public’s acceptance or rejection of the field. ^{Footnote 15}

Having laid this groundwork, chapter 2 raises various concerns about synbio. It begins by posing some leading questions, negatively phrased: “are we not on a collision course with objections of principle?; Can mankind indeed alter the universe which has been entrusted to it, can it make new forms of life appear? Is it not jeopardising the universe? Above all, is it not a manifestation of excess and of an unacceptable pretension? Is it not usurping the place of the Creator?” ^{Footnote 16}

It goes on to answer, and largely reject, such objections. Regarding the “playing God,” argument, it states, referring in particular to accusations against Craig Venter and his work on Synthia: “Clearly Craig Venter has not created life. The label of overweening megalomania would be attached to anybody who regarded himself as a creator in the strong sense that this term has in a religious context. Craig Venter has obtained a new life form, but to do that he has only exploited, after long and costly efforts, the natural properties of a bacterium which certainly did not owe its existence to him!” ^{Footnote 17}

Regarding whether humanity has the right to modify life, in this or other ways, the Opinion notes that it has been doing this in agriculture for a long time. It quotes from the Compendium of the Social Doctrine of the Church (a summary of the Church’s official teachings on “social” issues, primarily the economy and bioethics):

To this, COMECE’s authors add: “The human person is ... invited to behave as God’s associate, meaning that he reaches a heightened sense of his responsibility at the moment when he is altering the world that has been entrusted to him.” ^{Footnote 19} They also quote Pope Francis, directly quoting John Paul II: “Many recent discoveries have brought undeniable benefits to humanity. Indeed, they demonstrate the nobility of the human vocation to participate responsibly in God’s creative action in the world.” ^{Footnote 20}

They also urge prudence, however. They observe that humanity should not damage nature by its interventions. Humanity can develop nature’s potential, but not tyrannize it. Quoting again from the Compendium: “mankind must not “make arbitrary use of the earth, subjecting it without restraint to his will, as though it did not have its own requisites and a prior God-given purpose, which man can indeed develop but must not betray. When he acts in this way, instead of carrying out his role as a co-operator with God in the work of creation, man sets himself up in place of God and thus ends up provoking a rebellion on the part of nature, which is more tyrannized than governed by him.” ^{Footnote 21}

The Opinion quotes the Compendium again to note that proper risk–benefit analysis should always be undertaken in such research. The relevant professionals should not act “lightly or irresponsibly;” ^{Footnote 22} it would be “unacceptable” to do so. ^{Footnote 23} Two principles should guide this type of research in Catholic thought: namely, life should be respected; and the creation has integrity. ^{Footnote 24} Therefore, new technologies should not threaten human health or the environment. ^{Footnote 25} Environmental protection should extend into the future. The world’s biodiversity should be protected; the authors refer to the Cartagena Protocol on Biosafety here. ^{Footnote 26,Footnote 27} Biotechnologies should always be used in ethical ways, guided by solidarity and justice, enhancing the social, economic and social life of humanity. Scientific knowledge should be shared, trade should be fair, and developing countries should have access to the technologies. ^{Footnote 28}

Risks may extend beyond the environment, to the economy and society. On this, the authors quote Pope Francis on genetic modification, from his 2015 encyclical on the environment, Laudato Si:

The third chapter, “An Essential Framework for Practices,” begins by observing that synbio has “huge potential for development that will probably result in the acquisition of immense power of manipulation of living organisms.” As a result, it is attracting great interest from some business and political leaders. The authors note that it is hard to predict the course of synbio, and of the ethical and other issues that it may give rise to. They recommend precise regulations to govern the science. ^{Footnote 30}

Regarding safety and security, they state that synbio research and its products should be safe. This includes human safety (which encompasses workers’ rights), and protection of the environment. They briefly describe the biosecurity issue, focusing on the fact that amateur biohackers can create synbio products in home laboratories. They mention the bioweapons threat, and the potential for bioterrorism. They recommend deep reflection on governance, risk assessment, and monitoring, by the EU, its member states, and the international community. They also recommend the development of ethical guidelines within the scientific communities themselves. They note that the EU’s commitment to freedom of research does not override the common good.

Regarding international trade and justice, the Opinion notes that synbio may generate great prosperity for technologically advanced countries; obviously a positive development. However, it also notes that it could cause the technology and prosperity gap to increase between advanced and developing countries, both within and outside of the EU. The Opinion quotes, with approval, the EGE Group’s concern about this. ^{Footnote 31} It adds a quote from Pope John Paul II’s 1991 encyclical, Centesimus Annus, which calls for the breaking down of barriers, including monopolies that inhibit the development of nations and individuals. ^{Footnote 32}

Patents are then discussed. This begins with a longish quote from another COMECE Opinion, Patentability of Human Stem Cells. ^{Footnote 33} That document approves, in the most general terms, the patenting of biotech products. Significant investment may be needed to bring such products to fruition; and inventors should benefit from their inventions. Patenting also allows scientific knowledge to be disseminated. However, limits can be placed on intellectual property (IP) benefits; for ethical reasons, or if the common good requires it.

COMECE note that serious questions arise in biotech, particularly the issue of what should be patentable. ^{Footnote 34} They ask whether patents should be granted on biological material. They have adopted European Directive 98/44/EC of 6 July 1998’s definition of biological material: “any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.” ^{Footnote 35} Traditionally, patents have been granted on inert material. Biological material that can reproduce itself raises new issues, because although there is the issue of invention, as before, when the invention incorporates living material, patenting it may involve “the appropriation of elements of biological organisms by specific industrial actors or even the claim of a copyright on the living matter itself.” ^{Footnote 36} The authors note that “stiff opposition” will arise to such claims; ^{Footnote 37} as, indeed, it has. They observe that the European Patent Office allows a broad scope on biotech patents; patents can encompass a wide variety of biological functions. This may inhibit scientific research, and also reduce its applicability to developing countries. ^{Footnote 38}

The Opinion’s discussion on patents is brief, and raises questions for discussion rather than attempting to answer them. The issue of synbio patents is a complex one: ^{Footnote 39} synbio’s unique features of high level invention on a multiplicity of living, interlinked, evolving materials, which may combine with each other and the rest of nature in unknowable ways, combining with advances in electronics, robotics, and computing, including artificial intelligence, may require a rethink of the intellectual foundations of patent law. Biological inventions build upon nature, but cannot work without it. To describe such creations as inventions and apply current IP law to them is, arguably, to attempt to fit a square peg into a round hole. The IP law community itself has yet to resolve these issues. It has been suggested that new thinking in IP law may be required for synthetic biology. ^{Footnote 40} For example, the European Patent Office has published a detailed report that suggests possible ways in which IP laws may change over the next decades. ^{Footnote 41} A French government report has also suggested possible evolution of IP law. ^{Footnote 42} It is a challenging topic, made more so by the fact that it is impossible to predict the directions that synbio will take. Could the Church engage with the IP law and synbio communities, to offer guidance drawn from its ethical teaching?

The Opinion then discusses the need for wide-ranging societal debate on synbio, evaluating benefits versus risks, something that has not taken place up to now. ^{Footnote 43} It quotes Pope Francis on public debate on biological innovation in general:

The final topic for discussion is the applicability of synbio to human beings: “Insofar as it evolves, synthetic biology will obviously have profound repercussions on human beings and their life styles. However, we can expect that questions will emerge very soon about the direct application on the human body of inventions regarding the most diverse biological systems.” ^{Footnote 45} COMECE notes that synbio has the potential to greatly advance medicine, giving the example that alterations to the human genome have cured children who may otherwise have died or lived lives of great suffering. ^{Footnote 46} They also note dangers, giving the example of somatic versus germinal gene therapy. Somatic gene therapy is not transmitted to future generations; germinal is, and could transmit unknown consequences to future generations. They state that physicians rejected germinal therapy until recently; and that this should be a guideline for both legal and ethical deliberation, and enforced by regulation. Synbio’s output should serve human dignity, and be applied to cure illness and disability. Regarding synbio’s application to a Humanity 2.0 or singularity scenario, the Opinion restates church teaching on the issue, observing that human dignity requires “resisting any dreams of ‘enhanced humanity;’” ^{Footnote 47} because humanity is made in God’s image in the Church’s view.

The Conclusion to the Opinion briefly restates and summarizes the foregoing. Ultimately, it concludes that synbio offers both great potential advances for human civilization, and great threats to it. It expresses the hope that synbio will be used in a beneficial manner, and that negative uses should be prevented. Synbio and its potential applications should be studied in detail, so as to guide its development on a positive course. Also, benefits should accrue to both First World and developing countries; there should be collaboration between both. COMECE suggest that scientists should engage with synbio’s ethics, and be willing to impose limitations on their research, as has previously happened in bioscience research. ^{Footnote 48} They also recommend the establishment of governance structures. They encourage public debate. They recommend dialogue among scientists, public authorities, and the public, saying that the latter should play a meaningful role in the discussion and decisionmaking. They conclude that synbio is not “playing God.” It should be directed in a way that respects the Creation; and humanity’s common good. ^{Footnote 49}