Introduction
Major advances in biological sciences have yielded new ways of tackling various environmental and health problems. According to the European Medicines Agency (EMA), novel areas of research such the stem cells continue to reveal enormous potential health benefits such as development of clinical therapies for degenerative diseases such as diabetes, heart ,liver failure and Parkinson’s disease (3). In addition, scientists are also finding useful application of stem cells in reproductive technologies such as artificial insemination, cloning and In-Vitro fertilization (IVF). Due to certain aspects of these technologies, a lot of ethical and legal challenges have arisen in the recent past. The public, policy makers and also scientists have expressed concerns in the way the technologies are conducted and their possible future impacts.
This paper critically examines the legal framework of the European Union (EU) on the regulation of human tissue and cells with special attention to stem cells research and its applications. The discussion falls into four main parts. The first part outlines the key elements of policies undertaken by the EU to regulate research and applications of human tissues and cells in member states. The scope of various directives issued by the EU on blood, human tissues and cells and advanced therapy products are examined. It is identified that these legal frameworks constitute minimum standard of health and safety developed by the EU and delegated to member states for implementation. The second part takes a look at some of the ethical opinions that have been raised against the application of human material in biotechnology in the EU region to reveal that many thorny issues have never been resolved. In many cases EU took no position or simply forwarded them to national authorities. The next section deeply analyses stem cell laws in the EU and how they have been applied to settle patent disputes. This reveals a complex legal structure characterized by different interpretations of the same laws from the national courts all the way to final EU courts. In addition, it is shown how the case of “morality” greatly shapes the implementation of these laws. The final part compares the EU patent law system to that of the United States noting that stem cells patent laws not rooted on the generalities of “morality” or “public order” and a less complex legal system may be significant in contributing to a robust stem cell industry of a region.
EU Directives on regulation of human tissues and stem cell research
The Treaty of Amsterdam under Article 152 (4)(a) EC laid the foundation for regulatory policies for ‘high standards of quality and safety of organs and substances of human origin, blood and blood derivatives’ in the EU ( Hunt and Wallace 427 ). The need for regulation was contributed by factors such as rapid advancement in bio engineering and related technologies, ethical concerns of the general public about possible risks of bio-engineered products and growing commercialization of scientific innovations (Hunt and Wallace 433). The EU has to date undertaken regulatory steps by issuing standard regulatory frameworks for implementation at national level by member states. This has been through directives such as the Blood Directive, the Human Tissue and Cell Directive and more recently the Regulation on Advanced Therapies and Medicinal products.
In line with Article 152(4) EC, the Blood Directive was first published on 13th December 2003 (COM (2000) 816 final) and formally adopted on 27th January after institutional negotiations. EU member states were supposed to transpose the direction into law by 8th February 2005. The scope of the directive includes collection, testing, processing, storage and distribution (Art 2 (1) in addition to regulation of “any structure or body” engaged in these activities (Art 3 (e)). All blood establishments are required to operate under authority of a competent institution of their country and must be headed by a “responsible” person whose role is to oversee the adherence to the Directive. It also stipulates that the establishment must set up a system for monitoring donor-recipient exchanges (Art 14). The responsibility of ensuring compliance by the establishments in terms of quality operation systems, security and confidentiality of records is vested on the member states governments (Art, 11, 12, 13 and 24).
The Directive on Human Tissues and cells was first published in 2002 adopted in 2004 and member states were required to transpose it into law by 7th April, 2006. The catalyst for this move was the growing concerns about increased international trading in tissues and cells as a result of rapid advances in biosciences (Wallace and Hunt 431). This Directive established minimum standards of safety and quality in regard to the risk of infectious diseases by requiring the regulation by member states of “donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells” and their end products intended specifically for human application (Art 2 (1).The Directive applies “ to tissues and cells including haematopoietic peripheral blood, umbilical-cord (blood) and bone-marrow stem cells, reproductive cells( eggs, sperms), foetal tissues and cells and adult and embryonic stem cells”(Favale and Plomer 105). However, tissues/cells used for scientific research, autologous grafts, blood and blood components are exempted from this directive (Arts 1 and 2). Member states are also required to set up a “competent authority” headed by a qualified person tasked with implementing the directive through licensing, inspection and vetting of entities engaged in any human tissue/cell trade (Art 4(1), 5 and 7). The Directive also requires tissue establishment to submit annual report of their activities, ensure data protection and confidentiality and set up their own quality assurance systems ( Art 10(1), 16 and 14).
In April 2007, the European Parliament adopted the Advanced Therapies Regulation to extend its regulation on medicinal products used in advanced therapies (such as treating regenerative diseases) that are based on tissue /cell engineering and tissue/cell engineered products (Favale and Plomer 108). The scope of the regulation includes manufacturing, quality, safety and marketing of such product produced industrially and commercialized by member states.
Ethical Concerns
Novel Biological research and inventions have all along been subjected to ethical contests by religious bodies, politicians and human/animal rights groups all over the world. In the EU, the makers of the regulatory directives have either evaded ethical issues by settling on non-binding agreement or just shifted the concerns to the member states (Brownsword 30).
In the negotiations leading up to the formulation of the Blood Directive ethical concerns centered on whether voluntary, unpaid donations should be recognized over paid donations preferred by commercial health establishments. It was argued that commercialization had led to compromising the health of EU citizens through importation of cheap contaminated blood that had contributed to rise in transmitted diseases (Hunt and Wallace 433). On the other hand some advocated for the voluntary and unpaid donation arguing it was as the only way to procure blood of high safety. In the case of Tissue and Cell Directive, ethical differences between member states regarding controls on payments for tissues were never resolved. Instead, member states were directed to “take necessary measures to encourage voluntary and unpaid donations of human tissues and cells with a view to ensuring that, insofar as is possible, they are obtained from such donations”( Favale and Plomer 105). Even in recent Directives, long negotiations on sensitive ethical issues touching on human embryo stem cells have not produced any legally binding changes. This may be due to the fact that the European Group on Ethics (EGE), which is under obligation to provide ethical guidance on biotechnological inventions is not effective as its proposals are not legally binding to the European Court of Justice (ECJ),EPO, or the national patent offices where they may exert considerable influence (Plomer ,Taymor and Scott 17).
In all directives and regulation adopted so far, the criteria has involved setting minimum standards which member states were supposed to incorporate into their national laws in regard to their culture and other national priorities. Each of these policies seek to uphold the main objective of the Treaty of Amsterdam specifically Article 152 (4) (a) on which they were based on. That is, to protect the citizens of EU from health risk posed by rapid advances in biotechnology. However, these regulation policies have come under close scrutiny, when biological inventions with promising therapeutic benefits, particularly human embryo stem cells (hESC), have been rejected on controversial and sometimes conflicting grounds.
Stem cells patent laws
Research and patenting of innovation based on human embryonic stem cell continue elicit strong public debates (qtd. In Treichel 462). Major ethical concerns have centered on the argument that such activities involve destruction of a life form-embryo which should be accorded dignity and respect. This is out of the believe in some quarters that the human embryos are “human lives and have moral value [and] any patent on a human embryo would violate its dignity (Resnik 220). Moreover, it is argued that if stem cell research and patents are allowed the human embryo will be treated as a commodity and subjected to mass “abuse” by those seeking economic gains from it. The regulation adopted in the EU for regulation of stem cells patents and which possess strong moral undertones are based on the Councils of Europe’s 173 European Patent Convention (EPC) and the EU’s 1998 Directive on the legal protection of biotechnological inventions (Directive 98/44/EC) that contain clauses stipulating that “inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality”. The inventions are listed as (a) processes for cloning human beings; (b) processes for modifying the germ line or genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefits to man or animals, and also animals resulting from such processes.”. Member States were required to transpose this Directive into their national law a process which only served to entrench moral philosophies into biotechnological inventions laws in the whole of EU. This has been illustrated by later decisions adopted by the EU and even member states in settling human embryo stem cell patent disputes which has led some to view them as simply “policies …aimed at constraining controversial biotechnologies”(Caulfield and Brownsword 72).
The Council of Europe’s 1973 European Patent Convention (EPC) and the EU’s 1998 Directive on the legal protection of biotechnological inventions (Directive98/44/EC) among other things bar patents that involve industrial and commercial application of the human embryo and human stem cells derived from processes that involve destruction of embryo (Waldby and Salter 15). Such controversial standings have been attributed to norms from “outside”-EU charter of Fundamental Rights and the Council of Europe’s convention on Human Rights and Biomedicine that have been incorporated into EU biotechnology laws (Favale and Plomer 90). This coupled with the circumscribed competence of the EU to act beyond its tenets of “standard setting” legal frameworks has resulted in the regulation of scientific undertakings on a moral basis (Favale and Plomer 91).
In a landmark ruling, on the 25th November 2008 the Enlarged Board of Appeal (EBoA) of the European Patent Office (EPO) rejected a patent application by Wisconsin Research Alumni Fund (WARF) that involved primate Embryonic cells on the ground that the patent was against Rule 28(c) of Article 53 of the European Patent Convention which states “that the use of human embryos for “industrial or commercial” purposes should be excluded from patentability as this would be contrary to public order and morality” (Banadur and Morrison 14).In their ruling the Board stated future that patents will still be nullified if they involve processes that destroy the human embryo.
In a similar case, the German Federal Patent Court also revoked all claims relating to cells derived from to the human embryo stem cell lines on a patent by Oliver Brüstle challenged by Greenpeace that involved obtaining neural precursor cells from such cells for use in treating neurological disease. In its ruling the court cited Article 6(2) c of Directive 98/44/EC which in addition to containing a examples of cases ineligible for patenting on ethical grounds, outlaws the destructive use of the human embryo for commercial or industrial purpose. In addition, the court also highlighted the need to protect human dignity as per the Directive on Biotechnological inventions (Treichel 464).
Another relevant case is the revocation of a stem cell patent issued to the University of Edinburgh by the Opposition Division of the EPO on the legal grounds that it involved the use of human embryo for industrial or commercial purpose and thus contravened Article 6(2) c. However, what is unique about this case is that the board employed a broad interpretation of the article to arrive at its judgment stating that “even in the absence of a uniform moral approach to human ES cell in Europe, [Article 6(2)c] has to be interpreted broadly to encompass not only the industrial or commercial use of human embryos but also the human ES cell retrieved therefrom by destruction of human embryos”(Plomer, Taymor and Scott 15). This has been understood to mean that even patents based on established hESC shall still remain void due that the fact that their derivation involves the human embryo. This broad interpretation has not gone well with many nations. For example, the UK dropped it and adopted a less general definitional interpretation that distinguishes between totipotent cells ( cells capable of developing into an entire human being) and pluripotent cells which lack this capability. Broad interpretation of article 6(2)(c) has also been cited as potentially retrogressive in regard to research and development of therapeutic products based on hESC (Plomer 174). However, supporters of ESC ban have countered this stating that Article 5(1) of the 1998 EU directive on biotechnological inventions still provide for exploitation of stem cells as it allow patenting of elements (e.g. genes and stem cells) from the human body as long as no processes destructive of the human embryo are involved.
The above cases also illustrate the “morality factor” common in most EU legal suits on human tissue and cells whose origin is attributed to Art. 6(1) of the EU Biopatent Directive 98/44/EC which bars patenting inventions deemed contrary to ordre public or morality. However, the most contentious clause which has proven to key in patent suits due conflicting interpretations is found in Art. 6(2) (c) which states that “uses of human embryos for industrial or commercial purposes” shall be exempted from patentability. Despite using such general terms as “morality” and “industrial and commercial “at no place throughout the Directive have they been defined.
The “morality” clause has been cited as the main evidence for flaws in the European regulation of human stem cell research and its applications. It has been pointed out that basing major court decision such the WARF case on these clauses is likely to cause legal tensions in the EU owing to the cultural diversity of the member states that have different interpretations of the term “morality” (Plomer 174). However, the law organs of EU insist that whether a human stem cell invention is denied patent or not will depends on the interpretation of that patent by the respective state in regard to the question of “public morality” (Bahadur and Morrison 17).
There has been no consensus between EU legislators and national law systems
over the Biotechnological Inventions Directive of 1998, which ironically was aimed at harmonizing patent laws among member states (Bonetta 515)? Additionally, other than the confusion caused by this Directive, the complex legal structure and duplication of jurisdictional roles has also not helped much. The EU patent system is such that European Patent Office (EPO) will grant or deny a patent based on the EPC(European Patent Convention) 1973 Directive but this grant (with regard to Art. 6(2) (c) in Rule 28 will be based its legal and independent interpretation of the said article as specified under its own Implementing Regulations. EPC, it should be remembered does not constitute all the EU members. The same patent can still be subjected to national laws where moral considerations play a big role. Another hurdle is that the European Court of Justice (ECJ) may not overrule any decision of the EPO, because the EPO is under a different legal framework independent of the EU. However, the ECJ has jurisdiction over national patent laws and has powers to overrule their decisions. The result of this “legal maze” coupled with a pluralistic Europe is the different interpretation of the EU Directives more so the “moral exclusion” clauses by various member states. This is true of the UK patent Office, the Swedish Patent Office, EGE, EPO and the German Federal Patent Court in their interpretation of and exclusion of stem cells patents in regard to Articles 5 and 6 of the EU Directive on Biotechnological inventions Directive adopted in 1998.
The formulation process of the regulation policies has always been marred by compromises mainly contributed by ethical concerns that are never resolved. Protracted negotiations and lack of political consensus over whether Human Embryonic Stem Cell (hESC) should be allowed or even funded resulted in non-binding
commitments being inserted in the Tissue/Cell Directive. This commitments assert that decisions by Member States on hESC will not be contested basing on the rules of Directive but Member States that legalized hESC use should uphold the rights and safety of their citizen (Wallace and Hunt 434). This is plausible since it gives members states the discretion to enact measures which are in harmony with social-cultural, economic and political priorities of their nation (434).This may also explain the fact that there are varying approaches taken by EU member states on the issue of human embryos and embryonic stem cells such that there are nations such as UK and Sweden that allow research on Embryonic Stem Cells and those that have totally banned or restrict research that involves destruction of the human embryo-Germany, Austria, Italy, Finland, Greece, Ireland, Portugal, and the Netherlands (Bahadur and Morrison 17)
The inconsistent nature of the EU regulation policies is also revealed through a comparison of past and recent Directives. Plomer has pointed out that whereas commercial and industrial application of hESC patents are outlawed under the Biotech Directive, later Directives (i.e. Tissue and Cell Directive) and regulations recognize, allow and even encouraged activities related to the research and application of human embryo (180). In the new regulation on Advanced Therapies 1394/2007, it is the duty of member states to enact their own laws on “the use of any type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells” ( Favale and Plomer). Because these products are meant for human use (which other Directives do no prohibit), it can be understood that the use of human embryo stem cells even through processes that involve destruction of the embryo is permitted (Plomer 182). It therefore defeats logic why a regime would permit such activities yet bar the resulting inventions. She further states that since there is no measure of such a complex issue as morality it is impossible to determine how a patent goes against ordre public or morality (176).Furthermore, it is not clear how patent examiners who are mostly scientist are supposed to evaluate a patent basing on moral grounds (Plomer, Taylor and Scott 15).
Comparison between EU and United States regulations on human stem cell research and patents
In contrast to EU, the United States does not have any “morality clauses” on policies of regulating stem research and granting patents. However, there also have been similar moral concerns and these have also found way into the mainstream legal systems notably through the Weldon amendment which became law in 2004 that outlawed patents based “human organisms including fetuses and embryos” (Resnik 214). Another difference is that controversies on stem cell patents in the US usually centre on economic effects of broad claims instead of “morality” and “human dignity” standpoints common to EU ethical contests. Additionally, unlike in EU, ethical issues on hESC are solved by regulations outside of patent laws such as restricted federal funding for stem cells research (Bahadur and Morrison 14).There also are much fewer regulatory institutions compared to those of the EU. Such a permissive environment has made the stem cell industry to thrive as data indicate that as of 2008 the US had granted 41 patents on human embryonic stem cells while EPO was yet to grant a single one. (Waldby and Salter 16). Although it may be impractical to import this American system a few lessons could be learned from it.
Conclusion
The EU has exercised its mandate of ensuring the health safety of EU citizens by regulating research, manufacture, sale and use biologically-derived health products. This has been through regulatory frameworks/Directives that set minimum standard guidelines for adoption by member states. The regulation frameworks include: blood and Human tissue and cell Directives and the Regulation on ATMP.
Ethical concerns have always been raised about the various aspects of biotechnology, notably on the research and application of Human embryo stem cells. However, policy makers of EU have been unable to deal conclusively with these issues. Their efforts have been through arriving at non-legally binding settlements with the concerned parties in addition to forwarding the issues to national states. In many cases these ethical concerns have not found their way into the legislations adopted.
Complex legal structure and conflicting laws have greatly affected the exploitation of biological inventions in the EU. Previous legislations have tend to conflict with later regulatory measures. The broad interpretation of laws on human stem cells on the basis of “morality” has led to revocation of patents with high promises of health benefits. Arbitration of patent cases has not been uniform due to dissimilar jurisdictional levels of the EU governance system. The incoherence in the legal framework is evident in areas such as EU courts and at national levels where we have “permissive states” that allow or somehow restrict human embryo stem cells activities and “prohibitive states” that have totally banned any such activity. The above is in contrast to US where despite facing similar ethical challenges, the human stem cell industry has flourished due to friendly laws free of “morality” clauses.
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