Legal aspects of nanotechnology vs. COVID 19 / Aspectos jurídicos de la nanotecnología frente a COVID 19

Despite the lack of specific regulatory guidelines, many nanomedicines are on the market and their number is growing steadily. These are mainly used in cancer therapy because they require persistent toxic compounds and the tumor landscape is very difficult, which hinders effective drug treatment. The lack of formal regulation of nanomedicines and the manufacture of nanomaterials for health-related applications is a worldwide problem. Inconsistency among differentgovernment agencies results in some nanomedicines being classified as medicaldevices and others as drugs. Therefore, a global consortium for nanomaterialsregulation should be formed to advance these agendas and issue formal guidance to the research communities. Currently, in the context of nanomaterials in the European Union, we are dealing with both binding legal acts and non-binding legal acts, such as recommendations on the fair conduct of scientific research or on the application of a uniform definition of nanomaterials.

A pesar de la falta de directrices regulatorias específicas, encontramos en el mercado un número creciente de nanomedicinas. Se utilizan, sobre todo, en la terapia del cáncer, ya que requieren compuestos tóxicos persistentes y el paisaje tumoral es muy difícil, lo que dificulta un tratamiento farmacológico eficaz. La falta de regulación oficial de los nanomedicamentos y la fabricación de nanomateriales para aplicaciones relacionadas con la salud es un problema mundial. La incoherencia entre las distintas agencias gubernamentales hace que algunas nanomedicinas se clasifiquen como dispositivos médicos y otras como fármacos. Por lo tanto, debería formarse un consorcio mundial para la regulación de los nanomateriales con el fin de avanzar en esta agenda y emitir orientaciones formales para las comunidades investigadoras. En la actualidad, en el contexto de los nanomateriales en la Unión Europea, encontramos tanto herramientas jurídicas vinculantes, como no vinculantes; tal es el caso de las recomendaciones sobre la adecuada realización de investigación científica o sobre la aplicación de una definición uniforme de los nanomateriales. (AU)

Synthetic biology and biosecurity

This article discusses the conflict fields and legal questions of synthetic biology, esp. concerning biosecurity. A respective jurisprudential discussion has not taken place yet in Germany apart trom few statements and recommendations. But in Germany, Europe and the USA, it is generally accepted that a broad discussion is necessary. This is esp. true for the question of biosecurity and the possible dangers arising from Synthetic Biology (AU)

Este artículo aborda las campos de conflicto y las cuestiones legales de la biología sintética, especialmente lo relativo a la bioseguridad. La pertinente discusión jurisprudencial no ha tenido lugar aún en Alemania, al margen de algunas declaraciones y recomendaciones. Pero en Alemania, en Europa y en los Estados Unidos, es generalmente aceptada la necesidad de un debate respecto de este asunto. Esto es especialmente válido para la cuestión de la bioseguridad y de los posibles peligros derivados de la biología sintética (AU)

Synthetic biology and biosecurity.

This article discusses the conflict fields and legal questions of synthetic biology, esp. concerning biosecurity. A respective jurisprudential discussion has not taken place yet in Germany apart from few statements and recommendations. But in Germany, Europe and the USA, it is generally accepted that a broad discussion is necessary. This is esp. true for the question of biosecurity and the possible dangers arising from Synthetic Biology.

Reproductive Medicine and the Law: Egg Donation in Germany, Spain and other European Countries

El presente trabajo analiza los problemas jurídicos más importantes que plantea la Medicina Reproductiva que se practica en Europa, con una atención a la normativa imperante en países como Alemania y España. Así, los autores realizan un estudio pormenorizado de la regulación vigente en dichos países, comparando sus soluciones con las normas adoptadas en otros países comunitarios. Igualmente, se pone de relieve el ato riesgo de que la donación de ovocitos se mercantilice y se forme un comercio específico de compraventa. De esta forma, las diferencias existentes entre las legislaciones de los países, unas muy restrictivas, con prohibiciones o exigencias para las mujeres receptoras, y otras más permisivas con el uso de las técnicas de reproducción, puede dar lugar a un "turismo reproductivo" entre países, como efectivamente está sucediendo (AU)

This paper analyzes the key legal issues raised by Reproductive medicine practiced in Europe, with special attention to the rules prevailing in countries such as Germany and Spain. Thus the paper involves a detailed study of the regulation in force in those countries, comparing their solutions with the rules adopted in other EU countries. It also highlights the high risk of commodification in oocyte donation. In light of this, the differences between the laws of EU countries - some of them, very restrictive with prohibitions or requirements for recipient women and others more permissive with the use of reproductive technologies - can lead to a "reproductive tourism" between countries, as indeed is happening nowadays (AU)

Framework for setting up and operating biobanks.

With regard to the use of bio materials, there is a great need for clarification of the legal ramifications. And since procuring and storing bio materials is becoming an increasingly important point for answering molecular-genetic questions within medical research, finding an answer soon for the related legal and organisational questions is extremely important. This article examines the modern uses of bio materials, suitable types of legal entity for biobanks as well as questions related to ownership of samples.

Property, personality rights and data protection with regard to biobanks--a layered system.

The person from whom body materials were collected, first becomes their owner in analogy to section 953 German Civil Code. This applies also if the body materials were taken within the framework of a treatment contract and remain there after the treatment/diagnosis have ended. Only if an explicit consent of the patient was given to the effect that the body materials are to be owned by the clinic/doctor, only then is it possible to transfer ownership. A conclusive transfer of ownership does not occur. A complete anonymisation makes the body materials ownerless since an assignment to a person is not possible any longer. In this case, the former carrier of the body materials has no further chance to make claim to any rights. In that case, science and biotechnological industry are free to utilize the body materials. The former carrier of the body materials may make claims to benefit sharing only if instead of an anonymisation only a pseudonymisation takes place. However, it is common practice that the payment for damages according to existing rights to benefit sharing after unlawful use is quite small. Only a trustee model could achieve that property rights be observed, that personal or personality rights are protected in the best possible manner and that proper benefit sharing be done.

Group consent in population based research.

We showed in our presentation that both the informed as well as the community consent are indispensable elements for the collection, processing, use and transferral of indigenous samples and data. At the same time we find that these elements must be adapted to specific local as well as regional cultural particularities in order to function as effective standards. Moreover, these two instruments are not sufficient, but must be supplemented by further instruments. One major one is an international control agency which should be organized based on the principle of the charitable trust.

A legal framework for biobanking: the German experience.

Although biobanks are vital for modern medical research, serious concerns have been raised about the legal basis and framework of such endeavours. This led the German 'Telematics Platform for Medical Research Networks' ('Telematikplattform für Medizinische Forschungsnetze', TMF) to initiate a project in 2004 that was designed to place German biobanks on a sound legal footing. This project involved the planning, writing and evaluation of an expert report that addresses in great detail the legal issues concerning property rights, medical professional regulations, general liability insurance, resource continuity and research secrecy. Here, we provide a brief summary of the major results of this project.

Biotechnology and Law: Biotechnology Patents. Special Considerations on the inventions with human material

La Unión Europea y los Estados Unidos difieren considerablemente en las decisiones sobre la patentabilidad de los biotecnológicas, sin contar algunas excepciones. Las posiciones mas divergentes en cualquiera de las direcciones en relación con las invenciones biotecnológicas individuales establecen los márgenes de alcance del cual los miembros de la Organización Mundial del Comercio (OMC) pueden usar en la ratificación del artículo 27 del Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (TRIPS). Las decisiones que no estén en conformidad con el artículo 27 TRIPS permanecerán sin consideración. En los puntos más importante, los miembros de la OMC están de acuerdo: Los seres humanos no son patentables. Otras normativas pueden ser consideradas, pero uno puede asumir que ningún miembro de la OMC tiene intención de usarlo. Por lo cual, la esfera que involucre esta opción es solamente teórica. La situación cambia cuando se hace referencia a partes del cuerpo humano. Estas puedes ser patentadas, siempre que se creen artificialmente o sean separados del cuerpo humano. De acuerdo con la normativa en los EE.UU., esto será aplicable a todos los componentes excepto las células madre totípotentes. Pueden estar exentas de patentabilidad de secuencias de genes. El ámbito de esta área es, muy grande y permite muchas opciones para la aplicación de la normativa del art. 27 TRIPS. En cuanto a los procesos de patente para la clonación de seres humanos, el ámbito es ilimitado. Estos procedimientos pueden bien ser completamente excluidos de patentabilidad, como ocurre en la UE o pueden ser considerados patentables sin tener en cuenta su propósito, como en los EE.UU. Lo mismo ocurre a los procesos para la selección de células madre humanas, en los EE.UU. sin embargo, procesos en relación con genes humanos o con las secuencias de ADN solamente son posibles en ciertos casos especiales, como ocurre en la UE en relación con los procesos para la alteración de la identidad germinal genética de los seres humanos

The EC and the US differ considerably in their ruling on the patentability of biotechnological inventions apart from some exceptions. The most extreme positions in either direction with regard to the individual biotechnological inventions mark the margins of the scope which the WTO members may use for the ratification of Art. 27 TRIPS. Rulings which are not in accordance with Art. 27 TRIPS remain without consideration. In the most important point both WTO member agree: Human beings are not patentable. Other regulations could be considered, but one may assume that no member of the WTO intends to make use thereof. Thus the scope involving this option is only a theoretical one. The situation is different when it comes to the components of the human body. These may, provided they are produced artificially or are separated form the human body, be patente. According to the regulations in the US, this applies to all components with the exception of totipotent stem cells. They may be exempted from patenting entirely or their patenting is linked to far reaching conditions. As an example should be named here the regulation of the EPA for patenting gene sequences. The scope of this area is, thus, very great and allows for many options of applying the regulations of Art. 27 TRIPS. With regard to patenting procedures for cloning human beings, the scope is unlimited. These procedures may either be completely excluded from patenting as in the EC or may be considered patentable independent of their purpose as in the US. The same applies to procedures for gathering human stem cells in the US. Exempting procedures with regard to human genes of DNA sequences are, however, only possible in special cases, as form example in the EC with regard to procedures for altering the genetic identity of the germline of human beings. However, the interpretation of general patentability preconditions allows to influence the patenting of such procedure. This means, though, that the scope for interpretation is only a small one is this area

Biotechnology and law: biotechnology patents. Special considerations on the inventions with human material.

The EC and the US differ considerably in their ruling on the patentability of biotechnological inventions apart from some exceptions. The most extreme positions in either direction with regard to the individual biotechnological inventions mark the margins of the scope which the WTO members may use for the ratification of Art. 27 TRIPS. Rulings which are not in accordance with Art. 27 TRIPS remain without consideration. In the most important point both WTO member agree: Human beings are not patentable. Other regulations could be considered, but one may assume that no member of the WTO intends to make use thereof. Thus the scope involving this option is only a theoretical one. The situation is different when it comes to the components of the human body. These may, provided they are produced artificially or are separated from the human body, be patented. According to the regulations in the US, this applies to all components with the exception of totipotent stem cells. They may be exempted from patenting entirely or their patenting is linked to far reaching conditions. As an example should be named here the regulation of the EPA for patenting gene sequences. The scope of this area is, thus, very great and allows for many options of applying the regulations of Art. 27 TRIPS. With regard to patenting procedures for cloning human beings, the scope is unlimited. These procedures may either be completely excluded from patenting as in the EC or may be considered patentable independent of their purpose as in the US. The same applies to procedures for gathering human stem cells in the US. Exempting procedures with regard to human genes or DNA sequences are, however, only possible in special cases, as for example in the EC with regard to procedures for altering the genetic identity of the germline of human beings. However, the interpretation of general patentability preconditions allows to influence the patenting of such procedures. This means, though, that the scope for interpretation is only a small one in this area.

The chromatomembrane method used for sample preparations in the spectrophotometric determination of zinc and copper in pharmaceuticals.

The chromatomembrane cell (CMC) was used to extract zinc and copper and to preconcentrate them for their separation from pharmaceutical preparations. The method performance was evaluated at the determination of the enrichment factor, the linearity of response, the reproducibility, the accuracy and the sensitivity. In practice a five-fold enrichment has been enough provided that sample sizes of 0.825ml were introduced. Good linearities for zinc and copper (r(2)>0.99) were observed under this condition. The relative standard deviation (<3%) proved the good reproducibility of the method. The accuracy has been verified using model solutions, which were prepared from a certified reference. Recoveries of 98.8, 99.5 and 100.3% were achieved with solutions containing 0.1, 0.3 and 0.5mugml(-1) Zn(II), respectively. In case of copper 101.2, 99.6 and 100.6% recovery were obtained for 0.1, 0.4 and 0.7mugml(-1) Cu(II), respectively. The detection limits (three-fold of the signal-to-noise ratio) were estimated at 0.04mugml(-1) for both. The proposed method was applied on pharmaceutical preparations and the results were found to be in a good agreement with the contents guaranteed by the producers.

Gene tests and employees in an international comparison.

In this research, Professor Jürgen Simon and Christian Ravenstein have highlighted the general existing prohibition, in the labour field, of the undertaking of genetic tests that could mean discrimination for the genetic heritage of the worker. They have made a comparative study of several member States of the EU that have specific regulation on this area.

On-line collection/concentration and detection of sulfur dioxide in air by flow-injection spectrophotometry coupled with a chromatomembrane cell.

A simple and rapid procedure for SO2 determination in air was developed by using a flow injection analysis (FIA) system coupled with a 3-hole chromatomembrane cell (CMC). The CMC was applied for the on-line collection/concentration of SO2 from air into a solution of 2 g l(-1) triethanolamine (TEA) solution as an absorbing solution: SO2 was converted to SO3(2-) in the alkaline absorbing solution. The solution containing absorbed SO2 was introduced into the carrier stream of the FIA system. The amount of SO3(2-) in the absorbing solution was measured by spectrophotometry with a mixed reagent of pararosaniline and formaldehyde, and was converted to the concentration of SO2 in the air sample. A calibration graph prepared by using standard sodium sulfite aqueous solutions was adopted for the determination of SO3(2-) in the absorbing solution. The SO2 concentration in indoor air examined was found to be 22.7 +/- 0.2 ppbv using 20 ml of air sample with the air flow rate of 5 ml min(-1), where the relative standard deviation was 1.7%. The detection limit for aqueous solutions and air samples were 6.9 x 10(-8) M and 0.48 ppbv, respectively. The measuring time for one sample was about 10 min when a 20 ml air sample was used. The interferences from common anionic species, formaldehyde and acetaldehyde, were also examined.

An empirical survey on biobanking of human genetic material and data in six EU countries.

Biobanks correspond to different situations: research and technological development, medical diagnosis or therapeutic activities. Their status is not clearly defined. We aimed to investigate human biobanking in Europe, particularly in relation to organisational, economic and ethical issues in various national contexts. Data from a survey in six EU countries (France, Germany, the Netherlands, Portugal, Spain and the UK) were collected as part of a European Research Project examining human and non-human biobanking (EUROGENBANK, coordinated by Professor JC Galloux). A total of 147 institutions concerned with biobanking of human samples and data were investigated by questionnaires and interviews. Most institutions surveyed belong to the public or private non-profit-making sectors, which have a key role in biobanking. This activity is increasing in all countries because few samples are discarded and genetic research is proliferating. Collections vary in size, many being small and only a few very large. Their purpose is often research, or research and healthcare, mostly in the context of disease studies. A specific budget is very rarely allocated to biobanking and costs are not often evaluated. Samples are usually provided free of charge and gifts and exchanges are the common rule. Good practice guidelines are generally followed and quality controls are performed but quality procedures are not always clearly explained. Associated data are usually computerised (identified or identifiable samples). Biobankers generally favour centralisation of data rather than of samples. Legal and ethical harmonisation within Europe is considered likely to facilitate international collaboration. We propose a series of recommendations and suggestions arising from the EUROGENBANK project.

The online removal of dissolved oxygen from aqueous solutions used in voltammetric techniques by the chromatomembrane method.

The applicability of the chromatomembrane method for the removal of dissolved oxygen from solvents used in voltammetric measurements was investigated. The chromatomembrane cell combined with a flow-through system allows an online deaeration of solutions. These experiments employed a mercury film electrode as working electrode and differential pulse anodic stripping voltammetry as the measuring method. Different eluents with adequate supporting electrolyte (without analyte) were measured to determine the background current, whether any contribution of oxygen is detectable. Voltammograms of eluents deaerated with the chromatomembrane method are compared to those of eluents purged with nitrogen for several minutes immediately before the measurement. No differences in the background currents can be observed when defined flow rates of eluent and nitrogen are maintained. Determinations of cadmium and lead even indicate the high efficiency of this method.

La ley de células troncales alemana: contenido y crítica

En este trabajo, el autor analiza la nueva ley alemana sobre células madre, aprobada por el parlamento alemán el 10 de Mayo de 2002. En esta ley se prohíbe con carácter general la investigación con células madre de origen embrionario, aunque se permite bajo una serie de requisitos muy estrictos. También se analizan temas como el conflicto que surge a raíz de una muy estricta protección del embrión, como ocurre en esta ley, y el derecho constitucional a la investigación científica. También se hace una referencia a los problemas derivados de la falta de claridad de determinados artículos (AU)

No disponible