III.
DRAFT BILL
on research on human embryonic stem cells
1. SUMMARY OF THE VALID RELEVANT LEGISLATION AND PRINCIPAL DOCUMENTS
1.1. Legislative regulations and documents related to the administration of research on human embryonic stem cells and relevant legislation in the Czech Republic
1. Constitutional Act No.1/1993 Coll., Constitution of the Czech Republic, as amended.
2. Resolution of Czech National Council Presidium No.2/1993 Coll. on proclaiming the Charter of Fundamental Rights and Freedoms a constituent of the Czech Republic legislation, as amended by Constitutional Act No.162/1998 Coll.
3. Act No.20/1966 Coll., on Health Care, as amended.
4. Act No.206/2000 Coll., on Protection of Biotechnological Inventions and on the amendment to the Act No.132/1989 Coll., on Protections of Rights to New Branches of Plants and Animal Breeds, in the sense of Act No.93/1996 Coll.
5. Act No. 130/2002 Coll., on Research and Development Support from the Public Funds and on amendments in some connecting acts (Act on Research and Development Support), as amended.
6. Act No.218/2000 Coll., on Budget Regulations and on amendments in some connecting acts (budget regulations), as amended.
7. Act No.219/2000 Coll., on the Czech Republic Property and its Representation in Legal Relations, as amended.
8. Act No.320/2001 Coll., on Financial inspection in the Public Administration and on amendments in some connecting acts (Act on Financial Inspection), as amended.
9. Act No. 527/1990 Coll., on Inventions, Industrial Models and Suggestions for Improvement, as amended.
10. Act No. 121/2000 Coll., on Copyright, on Legislation connected with Copyright and on amendments in some connecting acts (Copyright Act).
11. Act No. 71/1967 Coll., on Administrative Proceedings (Rules of Aministrative Procedure), as amended.
12. Act No.200/1990 Coll., on Delicts, as amended.
13. Act No.160/1992 Coll., on Health Care in Non-Governmental Medical Facilities, as amended.
14. Act No.140/1961 Coll., Criminal Code, as amended.
15. Act No.101/2000 Coll., on Personal Data Protection and on amendments in some connecting acts as amended.
16. Act No.285/2002 Coll., on Donation, Tissues Taking and Graft and Transplantation of Organs, and on amendments in some connecting acts (Transplantation Act).
17. Act No.513/1991 Coll., Trade Code, as amended.
18. Act. No.552/1991 Coll., on State Inspection, as amended.
19. Act No.337/1992 Coll., on Administration of Taxes and Fees, as amended.
20. Act No.586/1992 Coll., on Income Taxes, as amended.
21. Government Decree No.462/2002 Coll., on the Research and Development Institutional Support from Public Funds and on Evaluating the Research Projects, as amended by the Government Decree No. 28/2003 Coll.
22. Government Decree No.461/2002 Coll., on Intentional Research and Development from the Public Funds and on Tenders in Research and Development.
23. Government Decree No.267/2002 Coll., on Research and Development Information System.
24. Convention on Human Rights Protection and Human Dignity in Connection with Biological and Medical Application: Convention on Human Rights and Biomedicine, dated on 4th April 1997 (published under No.96/2001 Coll.).
25. Supplementary Protocol to the Convention on Human Rights Protection and Human Dignity in Connection with Biological and Medical Application on Human Cloning Ban, dated on 12th January 1998 (published under No.97/2001 Coll.).
Government Decrees Summary related to the subject-matter
1. Government Decree dated on 7th January 2004 No.5 on Czech Republic Research and Development National Politics for the Period 2004-2008.
2. Government Decree dated on 19th March 1998 No.188, Government Legislative Regulations, as amended.
1.2. European Community Documents related to the subject-matter
1. Treaty on the European Economic Community Foundation as of 25th March 1957 (amended by the Amsterodam Treaty)
2. European Agreement starting the affiliation between the Czech Republic on the one side and European Community and its member states on the other (published under No.7/1995 Coll.).
3. European Parliament and Council Resolution No.1513/2002/ES dated on 27th June 2002 on Accepting the 6th European Community Scope Program for Research, Technological Development and Demonstrations contributing to building European research space and innovations (2002-2006), Official Journal L232 as of 29th August 2002 (Celex: 32002D1513).
4. Memorandum of Understanding between the Czech Republic and European Community on CR affiliation to the 6th European Community Scope Program for Research, Technological Development and Demonstration Activities contributing to building European research space and innovations (2002-2006), and the Sixth Euratom Scope Program for nuclear research and training activities also contributing to creating European research space (2002-2006).
5. Council Resolution No.2002/836/ES as of 30th September 2002 on specific program for research, development, technologies and demonstrations (2002-2006) executed by the Joint Research Facility, Official Journal L304 as of 29th October 2002, (Celex: 32002D0836).
6. EC Council Decree No.2659/2000 as of 29th November on use of Art. 81, par. 3 of the Treaty on Categories of Research and Development Agreements, Official Journal L304 as of 5th December 2000, Celex: 32000R659).
7. Resolution No.1/98 of Affiliation Council between the European Community and its member states on the one side and the Czech Republic on the other as of 24th June 1998 on Accepting implementation regulations for the state support as presented in article 64(l)(iii) and (2) Protocol 2 following this Agreement on ESUO Products (No.225/1998 Coll.).
8. Council Decree No.994/98 as of 7th May 1998 on Implementing Articles 92 and 93 of the Treaty on European Community Creation within some categories of horizontal state support (398R0994), Official Journal L142 as of 14th May 1998.
9. Council Resolution dated on 15th March 1996 on International Cooperation Perspectives in the Fields of Research and Technological Development (96/C 110/01), Official Journal C 110 as of 16th April 1996, (Celex: 31996Y0416).
10. Information of the Committee for the Scope Definition of the Community for state contributions for research and development, Official Journal C 045 as of 17th February 1996, (Celex: 396Y0217 (01) as amended by the Committee Announcement that modifies the scope definition of the Community for state contributions for research and development, Official Journal C 048 as of 13th February 1998, (Celex: 31998Y0213 (01); as amended by the Announcement of the Committee to Prolong the Scope of the Community for state contributions for research and development, (Celex: 52002XC0508/02).
11. EC Decree No.2897/95 as of 15th December 1995 on executing Article 1 of Council Decision No.94/762/ES on rules to announce the research results of European Community in the fields of Research, Technological Development and Demonstrations, Official Journal L304 as of 16th December 1995, (Celex: 31995R2897).
International Treaties and European Community Regulations related to the subject-matter
International Treaties
1. Helsinki Declaration 2000.
2. European Council Convention on Human Rights and Biomedicine, dated on 4th April 1997, and the Supplementary Protocol on Human Cloning Ban, dated on 12th January 1998.
3. Universal Declaration on Human Genome and Human Rights passed by UNESCO.
4. Universal Declaration on Civil and Political Rights.
5. Convention on Human Rights and Basic Freedoms Protection.
6. UN Convention on Children Rights.
EC Directives related to the subject-matter
1. Directive 2001/20/EC of European Parliament and Council as of 4th April 2001 on
Member states convergence of legislation, restrictions and administrative temporary situations, related to the appropriate clinical practice in connection with clinical experiments on medical products to use on humans.
2. Directive 2001/18/EC of European Parliament and Council as of 12th March 2001 on Intentional release of genetically modified organisms to environment, replacing Council Directive 90/220/EEC.
3. Directive 98/44/EC of European Parliament and Council as of 6th July 1998 on
biotechnological inventions legal protection.
4. Directive 98/79/EC of European Parliament and Council as 27th October 1998 on medical diagnostical facilities "in vitro".
5. Directive 95/46/EC of European Parliament and Council as of 24th October 1995 on personal protection from the perspective of using personal data and management of these data.
6. Directive 90/219/EEC as of 23rd April 1990 on genetically modified microorganisms controlled use.
2. ASSESSMENT OF CURRENT LEGISLATION, NECESSITY TO CHANGE THE LEGAL STATUS AND GOALS OF THE PRESENTED DRAFT BILL
2.1. Results of legal analysis towards proposed draft bill
The purpose of the presented draft bill, is - with regards to the state duty to respect the human dignity and protect human life even before birth - to legally streamline problems connected with research on human embryonic stem cells and set the conditions, under which it is possible to import already existing human embryonic stem cells, as well as obtaining human embryonic stem cells from so called redundant embryos for the research purposes. The legislation should determine rights and duties of people and responsibilities of administrative authorities in managing the human embryonic stem cells and their lines. The act should explicitly forbid creation of embryos for research purposes, as well as research on human embryonic stem cells where it is impossible to clearly prove that these were obtained from so called redundant embryos.
The field of research on human embryonic stem cells has not yet been covered in the Czech Republic by any legislation. The researchersī practice has been done so far praeter legem in the sense of Article 18 of the Agreement about human rights and biomedicine. Extensive interpretation of § 26, par. 4 of the Act No.20/1996 Coll., on People health care has been used while looking at research on human embryonic stem cells originating from so called redundant embryos. The interpretation has suggested to look at the embryonic cells taken within the framework of assisted reproduction as parts of human bodies taken away in connection with the treatment of infertility. This interpretation is not unambiguous and does not represent satisfactory legislation for the given issue.
2.2. Reasons for introducing a new legislation
The necessity for the legal regulation arises out of its matter, because the law will touch upon the rights and duties of legal entities and natural persons in the fields sensitive both from human as well as legal perspective, and also the relevant state administrative offices operations of will be streamlined.
The necessity for the legal regulation arises mainly from Article 1 of a sentence of the second Convention on human rights and biomedicine (N. 96/2001 Coll), which imposes on the contractual parties the duty to adopt plans of actions necessary to bring the Convention provisions into effect in their respective legislations. The issue itself is touched upon in article 18 that addresses the field of embryonic research in vitro (the article prohibits creation of human embryos purely for the research purposes and admits research of human embryos in vitro only under condition that the appropriate protection will be provided to the embryos). Therefore, the primary reasons for passing the law are the Czech Republic commitments resulting from the international legislation that have not yet been recently satisfactorily fulfilled. Suggested draft bill will also be in compliance with the Czech Republic constitutional order.
Provisions of the Charter of Rights and Freedoms (further "the Charter") which might be both positively and negatively touched upon while conducting the research, also support passing of the appropriate legislation in a given field. Namely the article 6, par. 1 of the Charter stating that human life is worth protection even before the birth, furthermore art. 15, par. 2 of the Charter streamlining the guarantees of free scientific research, or art. 31 containing the right for health protection.
The resulting draft bill is a moderated legislation that admits research on human embryonic stem cells. It does not presuppose creation of embryos for the research purposes, but only using the embryos created for the purpose of assisted reproduction, whose purpose of creation has passed. Alternatives of this presented approach would be either absolute liberalization of the research (executed de facto currently) or absolute prohibition of research on the human embryonic stem cells which would not be a factually appropriate resolution.
2.3. The goals of suggested legislation
The goal of the suggested legislation includes:
1. to determine conditions, under which it would be possible to obtain human embryonic stem cells for the purpose of research, from redundant human embryos arisen for the purposes of assisted reproduction, but later not used for quoted purpose;
2. to define conditions, under which it would be acceptable to import human embryonic stem cells into the Czech Republic; this import would be permitted only for the research purposes executed in the CR;
3. to realize the state duty to respect human dignity and protect human life even before birth in the field of research;
4. to prevent obtaining human embryonic stem cells for the research purposes by other means than legally determined way;
5. to prevent such manipulations with human embryonic stem cells within the research which could lead to creation of a new individual;
6. to legally regulate permitting process of research on human embryonic stem cells and registration of human embryonic stem cells lines.
2.4. The fields of applicability of the drafted legislation
The fields of drafted legislation:
1. the legislation streamlines conditions for obtaining human embryonic stem cells for research purposes;
2. it regulates rights and duties of legal entities and natural persons in the process of dealing with human embryonic stem cells and their lines assigned for the research;
3. it regulates competences of administration offices in the field of research on human embryonic stem cells;
4. it modifies conditions of import of human embryonic stem cells for research purposes to the Czech Republic.
3. PROPOSAL FOR MERITORIOUS SOLUTION OF THE ISSUE
3.1. Definitions
For the purpose of this law, the used concepts are defined as follows:
1. human stem cells - all the human cells that are able to divide and self-reconstruct themselves for a very long time in corresponding environment. They are non-specialized, but within certain, appropriate conditions can develop into specialized cell types, but cannot create an individual;
2. human embryonic stem cells - all the pluripotential stem cells that are descended from human embryos created outside a human body and that are treated in such a way that creation of a new individual is impossible;
3. lines of the human embryonic stem cells - all the human embryonic stem cells that are kept in cultures or are, in relation to them, stored in kryocanned form;
4. human embryo - totipotential cell or their groupings that are able, under fulfilling other conditions, to develop into a human individual;
5. import of human embryonic stem cells - transport of human embryonic stem cells to the CR;
6. bioethical committee - there are two variants:
a) Bioethical Committee that is an expert and advisory body to the Council for research and development;
b) Central Ethical Committee based at the Ministry of Health.
3.2. Conditions for research on human embryonic stem cells
1. Research on human embryonic stem cells can be executed:
a) on imported lines of human embryonic stem cells, provided that they were obtained in such a proven way that does not object against Czech legislation and the only reason for their import is their usage for research purposes in the sense of this draft bill;
b) on the lines of human embryonic stem cells obtained in the CR from an embryo created under medical supervision through the method of artificial insemination outside of a human body for the purposes of assisted reproduction, but later not used for these purposes. 1
2. Research on human embryonic stem cells can be executed only, if scientifically proved that:
a) it serves scientific goals for obtaining significant scientific data in the course of research or for enlarging medical knowledge in development of diagnostical, preventive or therapeutical methods applicable on the man;
b) according to the current knowledge of science and technology it solves questions that are to be clarified through the research project, and that have already been studied on in-vitro models with animal cells or in experiments on animals, and
c) expected scientific contribution to the issue could be reached only if using human embryonic stem cells.
3.2.1. Obtaining human embryonic stem cells for research purposes from redundant embryos
Obtaining human embryonic stem cells for the research purposes from redundant embryos is possible under the following conditions:
1. a redundant embryo can be used for obtaining human embryonic stem cells for the research purposes only in the case that a woman (and if married, also her husband) gave consent to this, based on written application. This consent must be delivered prior to using the embryo for obtaining an embryonic stem cell. Before a woman (and if married, also her husband) gives her consent, it is necessary to inform her orally and in writing in an understandable and sufficient way for which purpose the redundant embryo would be used. A woman (and if married, also her husband) gives consent to the organization providing the taking of the embryos. This organization will also clarify the purpose, for which the embryo (more precisely, its stem cells) would be used. The information must be carried in such a way that she would understand how the embryo would be further treated. In her written consent, a woman (and if married, also her husband) must state that she agrees with using the embryo for creating stem cells further used for research purposes. This agreement must contain also first names and surnames and permanent address of a woman (and if married, also her husband), confirmation about having been informed undersigned by the institution having provided the information, along with the institutionīs name and address.
2. a woman (and if married, also her husband) can be asked for giving consent only at the time when it is already evident that the embryo will not be used for reproduction purposes;
3. a woman (and if married, also her husband) can withdraw her consent without stating the reason at any time prior to using the redundant embryo for obtaining embryonic stem cells, however, this withdrawal must be submitted in writing;
4. a woman (and if married, also her husband) will not accept any financial compensation for using the embryo for research purposes;
5. in case that a woman (and if married, also her husband) is not alive, or is unknown, the decision-making right does not transfer to any other person and such embryos might be used for obtaining human embryonic stem cells for research purposes, if all the other legal conditions are fulfilled.
3.3. Permission of research on human embryonic stem cells and import of the human embryonic stem cells lines
1. Any research and import of human embryonic stem cells for research purposes require permission granted by the respective administrative authority. This administrative body will request the statement of the bioethical committee always while permitting any research. At permitting the import the administrative authority can ask for the statement of bioethical committe. Statement of bioethical committee will clearly recommend or not recommend this permission and will state the reasons for the decision. Every permission for the research will be given an identification number. The data about human embryonic stem cells and their lines are subject to protection according to a special legal regulation. 2
2. It is possible to apply for a permission to import human embryonic stem cells only:
a) simultaneusly with the application for permission to execute research;
b) for a research that has already received permission, minimum 9 months prior to the expiration of validity of the permission.
3. Application for permission to execute research can be submitted only in writing or electronically via Internet. The concrete form of delivery is to be decided by the administrative authority. The applicant can be only a legal entity with the registered office in the CR, whose main activity is research and development and is capable to prove practice in research fields related to research on human embryonic stem cells. Potential import of human embryonic stem cells is bound with a concrete research project that is subject to permission.
4. The application itself, resp. added documents, must provide the following data:
a) name, address and identification number of the applicant asking for permission to execute research
b) name, or names and surnames and permanent addresses (including an address of
stay for the foreigners) who represent an authorized representative of the applicant for permission to execute research
c) providing a statement of criminal record for the authorized representative not older than 180 calendar days (meaning that an individual serving as the authorized representative has not been convicted of a crime according to the special legal regulation3).
d) name, or names and surnames, and permanent address (or an address of stay for the foreigners) of a person responsible for the research project;
e) description of the research activities, including scientific justifying statement confirming that research project is in concordance with this law, in the sense of paragraph 3.2.;
f) other documents that the administrative office will find necessary to permit the research, and will list them in respective public notice.
g) documentation about previously executed researches in relevant sciences.
5. Import of the human embryonic stem cells lines is permitted only if they are obtained from redundant embryos determined for the artificial insemination, and if their obtaining is in concordance with the Czech legislation. It is possible to import only lines that are registered in the registers, the list of which is specified in a public notice. In the application for permission to import it is necessary to include:
a) name, address and identification number of the organization executing the import of the lines of human embryonic stem cells;
b) the country where the line has been registered (including registration data for the respective country) and the country of origin, if known;
c) other data found necessary to permit the import by the administrative body who will list them in respective notice;
d) for the embryonic stem cells import for already running research, the identification number of permission for research and organization name and address is also required.
6. Redundant human embryos for stem cells usage can be provided only by medical facilities determined to provide health care in the field of assisted reproduction according to special regulation (center for assisted reproduction).4,5 Only institutions executing permitted relevant research can obtain stem cells from human embryos, in the sense of this bill.
7. After receiving an application, the administrative body will request the statement of the Bioethical committee, in cases described in 3.3., par. 1. The Bioethical committee is obliged to submit its statement within 6 weeks after having received the application. After receiving the statement, the administrative office will deliver the decision to the applicant. The permission can be granted to the applicant only if all the conditions listed in 3.2. and necessities coming out of the previous points 1-6 are fulfilled. Furthermore, all the following conditions must be fulfilled:
a) scientific level of the research that is to be permitted,
b) the research project is ethically acceptable, i.e. in concordance with the ethical codex of the Bioethical committee,
c) the statement of the Bioethical committee is available, provided that the administrative office had requested same,
d) any other conditions listed in this bill.
Permission under point 1 is granted for the time restricted period, for a maximum of 6 years, and for the concrete research project described in the application. The permission can be prolonged only once, for a maximum of 4 years. Administrative procedure code applies with the exception to the time of the application disposing, given in this bill.
8. If all and complete data are available, as well as the statement from the Bioethical committee, the respective administrative body is obliged to decide in writing, or to request additional information, within 3 months after the day of having received the application. In case that the respective administrative body statement deffers from the Bioethical committee statement, it is obliged to state the reasons for this in writing. Unsufficient description of the research activities listed in part 4 e), can conclude in no permission for the project, as well as other non-exact or incomplete data submitted by the applicant.
9. Authorised employees of the administrative office and other individuals authorised by the administrative office can carry out the inspections on the place of research even without announcement, to check on the conditions for which the research granted permission.
10. A person responsible for the permitted research, an authorized representative of the organization executing research on human embryonic stem cells or their deputies are obliged to provide requested data concerning the research to the inspection, as well as any other requested data that would be found important to clear up the circumstances for execution of the research, including financing the research.
11. Administrative body will issue the report within the next 20 days after the inspection. It would list found weaknesses, and requested way and dates to eliminate them. The report will be immediately sent to the authorized representative of the inspected organization and to the person responsible for permitted research.
12. The inspection activities of the administrative offices not mentioned in this bill, are regulated by the special legal regulation. 7
13. A person responsible for the research project is obliged to announce immediately any cardinal changes in the research that deal with permissibility of import or usage and status of human embryonic stem cells to the administrative office. Based on this new information, the administrative body can modify its permission, within three months after announcement. In the name of qualified decision, the administrative body can request a new statement of the Bioethical committee which would submit it within three weeks.
14. The respective administrative office charges the applicants for executing decision, resp. other connecting activities. While charging the fees, the administrative body is regulated by the respective administrative procedure. 8 The administration costs are covered by the applicant also in the case that the permission was not granted.
3.4. Administrative office for permission of research on human embryonic stem cells
(the draft is submitted in variants).
Variant 1
Ministry of Health. This ministry, as the central administration office, can delegate the execution of administrative procedure to another proper institution, as its promoter.
Variant 2
The tasks of the administration office are executed by the Academy of Sciences of the Czech Republic. It is authorized to do so by this regulation.
Variant 3
The tasks of the administration office are executed by the Ministry of Education, Youth and Sports in cooperation with the Ministry of Health, possibly also with the Office of the Government.
3.5. Bioethical Committee
(1) The committee will consist of minimally 7 members, with the mandatory representation of biologists, medical doctors, moral philosophers, lawyers and sociologists.
(2) The activities of the Committee will be led by its Charter.
3.6. Registration of the human embryonic stem cells lines in the Czech Republic
1. The register will include the basic data:
a) about the lines, their characteristics and features,
b) about the working place in the CR where the lines are being used,
c) identification number of the project where they are being used,
d) agreement of a woman (and if married, also her husband) to use the embryo for obtaining stem cells in cases specified by this bill,
e) whether they were obtained in the CR, or the country of origin,
g) data about foreign registrations,
h) data about the lines termination,
i) other data required by the regulations.
2. Research that is permitted by the administrative body, can be executed only on the lines registered in the Czech Republic. Legal entities that are per 3.3 authorised to execute research are obliged to register the stem cells lines within 10 working days after the day of obtaining them. All the imported lines must be registered by the institution executing research within 10 working days after the day of receiving them. Any changes in data about the lines and completion of the new lines will be announced by the legal entity executing the research within 10 days after the change has occured.
3. Within three days after receiving requested data, the administrator of the register will issue a confirmation about registration or about data changes, if all the necessities requested by this law are fulfilled.
3.7. Sanctions/ Punishments
3.7.1. Crimes
Unauthorised use of a human embryo is the subject of the Criminal act amendment No.140/1961 Coll. (further see also 4.1.). This act (or new Criminal Code) will be amended in connection with preparation of the Research on human embryonic stem cells Act. The amendment will cover punishments for using human embryonic stem cells under conditions different from the ones presented in 3.2 and 3.3 and executing research on human embryonic stem cells under other conditions than presented in 3.2, 3.3 and 3.6 with the duration of sentence comparable to the sentences punishing unauthorised use of the embryos (i.e. up to three years, possibly prohibition of activities) in drafted version of the criminal act.
3.7.2. Delicts
The duration of sentence is expected to be up to one year, connected possibly with prohibition of activities. A new delict with the fine of up to 50,000 CZK will be introduced for legal defects with a lower degree of social dangerousness (incomplete or incorrect data that are not of the principal character provided by the applicant in order to receive permission). For not cooperating with the inspectors on the inspection, a fine of up to 50,000 CZK can be charged. In case the delicts are repeated, the administration can withdraw the permission to research human embryonic stem cells.
3.7.3. Administrative delict of the legal entity
In case that weaknesses found during the inspection will not be removed within the given time or have been discovered repeatedly, the legal entity can face termination of its permission to research human embryonic stem cells.
3.8. Temporary provisions
Research that has been started before this act came into effect, must be completed within two years after this act comes into effect. Then, the researcher has to apply for a permission according to this act. Sanctioning responsibility will be regulated by 3.7.
4. PROJECTED INFLUENCE OF THE DRAFT TO THE JURISDICTION
4.1. Amending clauses/statements
Amendment of Act No.140/1961 Coll., Criminal act, as amended, will cover crimes presented in 3.7.1., in concordance with the suggested new version that includes the crime "unauthorised use of human embryo and human genome".
From the perspective of prepared legislation, given field will be touched upon in the act on the health care, resp. in any other legislation on assisted reproduction. However, it is presumed that preparation of the draft bill on human embryonic stem cells will be executed in concordance with the preparation of the bill on health care.
In case of realization of variant 3 presented in 3.4, possible legal modification of research and development information system of (IS RaD) is expected. So far, it has been used only for information concerning public support; it would be done through amendment of Act No.130/2002 Coll., on the research and development support, as amended, and its legislative instruments. It is especially expected to modify § 30 of this act, where the function of IS should be defined as the information register, see 3.6. Concrete content of this register will be defined in § 32 of the act. At the same time, any modification of respective statements in the government decree No. 267/2002 Coll., about the research and development information system will be executed (for instance §1, §10, and new rules concerning data about the human embryonic stem cells lines of will be amended).
With regards to the fact that permission to research human embryonic stem cells will have to be submitted also when requesting public support, further amendments of Act No.130/2002 Coll., can be expected. This act should reflect also the administration of the human embryonic stem cells research. Current status of respective Bioethical committee will be adjusted and in case that variant a) in 3.1.6. (Bioethical committee) would be accepted, this adjustment will be reflected in §35, Act 130/2002 Coll.
The act does not touch upon the regulations on experimenting with medicines and testing so far unknown methods in medical practice.
In case of realizing the variant 2 in 3.4, also the Act on Academy of Sciences of CR will be amended to introduce responsibilities and tasks rising from the new reality. It concerns especially §3 and amendment for further regulations, in connection with fulfilling the role of the administrative office in the sense of a presented draft bill.
Furthermore, it will be necessary for the Bioethical committee to implement this act into its charter and organizational guidelines and to come up with the ethical kodex, which would serve as the basis for its statements.
4.1.1. Assessment of the harmony between the drafted legislation and the international treaties binding the CR and its compatibility with the European Community legislation
Treaty on the European Economic Community Foundation as of 25th March 1957 (version after accepting Amsterodam Treaty) covers research and development in chapter XVIII (Research and Technological Development); general clauses on public supports are also relevant. This clause only states that the Community and member states coordinate their activities in research and development in such a way to ensure the compatibility of their national politics with the Community (art.165). These clauses do not presuppose the convergence of member states legislation with the Community one. Therefore, the subject matter covered in presented draft bill is not directly addressed by the Treaty on the European Community Foundation.
On December 13th, 2002, the Czech Republic signed the "Memorandum of understanding among the Czech Republic and European Community about the Czech Republic affiliation to the 6th Framework program of EC for research, technological development and demonstration activities which contribute to creation of the European research space and innovations (2002-2006) and Sixth framework of Euratom for nuclear research and training activities also contributing to creation of the European research space (2002-2006)". The main goal is to contribute to the foundation and functioning of the European research space. Its activities are oriented especially to so called Integrated projects. From this point of view it is necessary to establish such an institutional and organizational order of subjects that would deal with the given matter (including also subjects that will be created or will be influenced by the act about research on human embryonic stem cells) that would be compatible with the institutional and organizational order in EU countries, therefore it would enable and encourage application of Integrated EU projects, including international cooperation.
The draft version of the bill re: research on human embryonic stem cells fully respects acqui communitaire for granting public support, according to which research and development public support is not subject to any exception to the rule (article 87 of the Treaty about Foundation of European Community, article 64 of European Agreement among the EC and the CR and Decision 1/98 of Accession Council among EC and their member states on one side and the Czech Republic on the other, from 24th June 1998 on passing the code of practice for executing the clauses about the state support). Act No130/2002 Coll. on Research and development support, as amended, and other national laws (see chapter 1.1) in concordance with the EU legislation, cover also the issue of supports provided to the research on human embryonic stem cells.
The draft bill on Human embryonic stem cells research comes out of the Act N.20/1966 Coll., on Public health care which, in the drafted form, is in concordance with the EU legislation. Therefore, the draft bill on Human embryonic stem cells research is in concordance with the principles of European Convention: Convention about human rights and biomedicine (principles of research on embryos in vitro, principles of human genome, principles of protection and quarantees in the field of human rights, etc.) In this sense it is necessary to draw attention to Article 16, chapter V of mentioned European Charter which determines conditions for research on human beings (including research on human embryonic stem cells). These conditions were inspired by Recommendation R(90)3 by the Board of ministers of the member states concerning medical research on human beings. The draft bill respects above mentioned conditions, including the condition of independent judging of scientific value and ethical acceptance of a research project through the tool of independent multidisciplinary ethical committees.
In the sense of draft bill on Human embryonic stem cells research related to the Act No 206/2002 Coll., as amended, it is necessary to mention also the fact that EC passed the Directive 98/44/ES of European Parliament and the Council from 6th July 1998, Celex: 31998L0044 concerning legal protection of biotechnological inventions. It includes the principle according to which "the human body and its elements in natural status must not be considered patentable inventions." The draft bill has respected this principle. The draft bill is also in concordance with other ES directives, especially:
Directive 2001/20/EC of European Parliament and Council as of 4th April 2001 on Member states convergence of legislation, restrictions and administrative temporary situations, related to the appropriate clinical practice in connection with clinical experiments on medical products to use on humans;
Directive 2001/18/EC of European Parliament and Council as of 12th March 2001 on Intentional release of genetically modified organisms to environment, replacing Council Directive 90/220/EEC;
Directive 98/44/EC of European Parliament and Council as of 6th July 1998 on biotechnological inventions legal protection;
Directive 98/79/EC of European Parliament and Council as 27th October 1998 on medical diagnostical facilities "in vitro";
Directive 95/46/EC of European Parliament and Council as of 24th October 1995 on personal protection from the perspective of using personal data and management of these data;
Directive 90/219/EEC as of 23rd April 1990 on genetically modified microorganisms controlled use.
The principles for protection and guarantees in the field of human rights in the Czech Republic that have been touched upon in the draft bill about research on human embryonic stem cells originated from different international treaties, for instance: General Declaration of rights and freedoms, Universal Declaration on Civil and Political Rights, Convention on Children Rights, Convention on Human Rights and Basic Freedoms Protection. Therefore, it is possible to conclude that the draft bill on research on human embryonic stem cells is not in conflict with international treaties.
From the above mentioned facts it is apparent that the draft bill on research on human embryonic stem cells is compatible with the international treaties that are bounding for the CR, as well as with the legislative aquis of EC, therefore there is no need to modify it from this reason.
4.2. Concordance with the Czech Republic constitutional order
The draft bill is in concordance with the Czech Republic constitutional order.
5. PRESUMED COSTS FOR THE ACT IMPLEMENTATION
In case of establishing the Bioethical committee, no matter which variant will be chosen (see 3.1.6.), no expenses for wages, including social welfare and health insurance costs are expected. In case of a), further expenses are covered by the public funds allocated to the Council for research and development in the sence of §3, par. 6 of Act No. 130/2002 Coll., on Research and development support, as amended. Both the variants count on using expert committees and public representatives who are not in employer-employee relationship with the Czech Republic, therefore estimated costs of 200,000 CZK are sufficient to cover just organizational and operational expenses.
To secure the function of administrative office, estimated 500,000 CZK cover organizational and operational expenses, and 800,000 CZK cover the wages for the two employees, including social welfare and health insurance.
In case that variant 3 in the sense of 4.1. will be adopted, using IS of the Office of the Government will increase the costs by 500,000 CZK to cover one more wage incl. social welfare and health insurance for 1 employee of the secretariat of the Committee. The costs to run IS are estimated at 150,000 CZK in the first year of the operations, and 40,000 CZK in every other year.
All the above listed costs will be covered by the state budget.
Except for the above listed claims for the state budget, presented draft bill has no other impact on other public budgets, on the economical subjects (including small and medium-sized enterprises), neither will have any social influence, nor impact on the environment.