Difference between revisions of "Team:Pasteur Paris/Law"

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             <div class="block title"><h1>Ethics in the NeuronArch Project</h1></div>
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                <h1>Regulation concerning medical devices </h1>
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                <p><i>A new legal framework for medical devices ?</i></p>
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                 <p>
+
                 <p>As the iGEM Pasteur Paris 2018 team is developping a new type of bionic prosthesis using a genetically modified biofilm, whose aim is to act as an interface between the human body and the machine, we were wondering how it would be regulated and which legal regime would be applied. We asked ourselves: <i><b>is the actual legislation sufficent to oversee the different aspects of the NeuronArch Project ? </b></i></p>
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                    When speaking about ethics, we generally think about the branch of philosophy that studies the concept of good and evil. Indeed, it is a general way to describe ethics, which is gaining in importance in the scientific field.
+
                <p>For the purpose of defining the legal status of our medical device, we decided to first examine the evolution of the legal regime and the legal definition, then analyze the different questions that can be raised and finally have a glimpse of the american system concerning medical device regulation.</p>
−
                    It is important to note that ethics and law do not totally overlap. Something can be illegal and ethical, while something else can be legal but unethical.
+
−
                    It is also important to note that ethical rules can have different sources such as State, committees, scientific panel, etc.
+
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                    As our project aims to enhance living conditions of amputees, our project is closely linked to human health and human data. Research on human beings include scientific studies, use of biological samples, psychological studies, personal data, interviews, observations, etc.
+
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                    As we wanted to know more about the living conditions of amputees, we decided to meet with the committee of the Institut Pasteur in charge of helping scientist concerning ethical questions.
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             <div class="block title" id="One"><h3 style="text-align: left;"></h3></div>
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             <div class="block title" id="France"><h3 style="text-align: left;">The legal regime of medical devices in France</h3></div>
 
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                 <p>In order to better understand the functioning of the ethics committee of the Institut Pasteur concerning research on human beings, we interviewed Dr. Odile Gelpi, Director of medical affairs and public health at the Institut Pasteur </p>
+
                 <p>Medical devices have been regulated quite recently. Indeed, as drug regulations exist since 1965 and have been harmonized in Europe, medical devices were not regulated until 1990. </p>
−
                 <p>A committee has been created within the Institut Pasteur, in charge of advising researchers on ethical questions concerning human research. This committee meets during sessions called “Open Desk”, which have been set up since the end of 2016. The aim of the Open Desk is to facilitate exchanges concerning ethics and to guide researchers. The advantage of the Open Desk is that everyone is gathered in one session, which permits a more in-depth discussion with a confluence of different points of view and an overview of all ethical questions the researcher has to pay attention to.</p>
+
                <p>The philosophical ideas behind regulating drugs and medical devices are quite different. Indeed, the strategy of « the new approach » was applied to medical devices. It was based on a mutual recognition. Thus, member states of the EU were forced to admit on their territory, medical devices that were meeting the state of origin’s standards.</p>
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                 <p>The Open Desk is mainly directed by the translational research department. However, the Open desk committee’s composition is diverse, with persons coming from different departments. Moreover, the composition of the committee is adapted as much as possible to the subject presented.</p>
+
                 <p>Since this system was considered as having a too weak control on medical devices, a revision was made in 2007 in order to partially correct these weeknesses. However, the « Breast implant scandal » made the legislator realise that the « new approach system » was insufficient to ensure the safety of EU citizens.</p>
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                 <p>it is important to note that the goal of the Open Desk is to help researchers to be conscious of all the ethical aspects their research are related to. The Open Desk we presented in front of was related to human research, however, other Open Desks exist such as the Open Desk concerning research on animals. </p>
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                <p>The European Parliament regulation (EU) 2017/745 and of the EU Council of 5th April 2017 was adopted and its 2 main goals were : ”<i>ensure smooth functioning of the internal market as regards medical devices</i>” and the setting of “<i>high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products</i>”.<sup>1</sup></p>
 +
                 <p>The definition of a medical device in very important, as it has to determine which procedures have to be followed and which laws it falls under. A medical device is defined as « <i>any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:<br>
 +
                <ul>
 +
                    <li style="text-align: left;">diagnosis, prevention, monitoring, treatment or alleviation of disease, </li>
 +
                    <li style="text-align: left;">diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, </li>
 +
                    <li style="text-align: left;">investigation, replacement or modification of the anatomy or of a physiological process, </li>
 +
                    <li style="text-align: left;">control of conception, </li>
 +
                </ul>
 +
                and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means »<sup>2</sup> . This definition is conceived as a reverse definition of drugs.</p>
 +
                 <p>As “medical device” is a very broad group of products, a classification exists and permits the application of different procedures, depending on the class of the product (class I ; class IIa ; class IIb ; class III). This classification is based on their potential to cause harm.</p>
 +
                <p>The regulation (EU) 2017/745 has permitted some changes, for example, in the classification, which changed our device from a IIb class to a class III device. It has also set up a « Unique Device Identification System » and the « Eudamed » database, which is a key aspect of the regulation.</p>
 
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             <div class="block title" id="Two"><h3 style="text-align: left;"></h3></div>
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             <div class="block title" id="Questions"><h3 style="text-align: left;">Questions raised by the NeuronArch project</h3></div>
 
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                 <p>As Human practices are an integral part of the iGEM competition, and as we must think about the impact of our project as a whole on the society, we wanted to create a survey in order to have a better understanding of people’s opinion about our project. As we also wanted to better understand the everyday life of amputees and people wearing prostheses, we thought about interviewing volunteers. However, as those type of information are personal and medical data, we thought we should talk about our plans to the committee.</p>
+
                 <p>According to Regulation 2017/745, medical devices “<i>shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety</i>“.</p>
−
                 <p>We decided to present our project in front of the committee for them to give us an outside perspective of our work. Indeed, they took time to explain to us that interviewing amputees and people wearing prostheses was, indeed, human research and that the people we were interviewing had to be seen as patients. They pointed out the fact that, as students, we did not have the qualifications to talk about such subjects, and that we would need the help of a psychiatrist.</p>
+
                 <p>We raised questions about some aspects of the NeuronArch Project, such as responsability, legal questions around the software that would be used together with our prosthesis, and the question of GMOs.<br>
−
                <p>However, they suggested that we could talk to health professional and association representatives instead, so we would be able to collect information about patients. </p>
+
                <ul>
 +
                    <li style="text-align: left;">Responsability : obligations of the manufacturer (article 10 of Regulation 2017/745), obligations of the importers (article 13 of Regulation 2017/745), obligations of the distributors (Article 14 of Regulation 2017/745), manufacturer’s obligations applied to importers, distributors or other persons (Article 16 of Regulation 2017/745) .</li>
 +
                    <li style="text-align: left;">NeuronArch App : new obligations born from the statut of the software, depending on whether considered or not as a medical device.</li>
 +
                    <li style="text-align: left;">GMOs : can we launch a medical device inserting GMOs in human body ? The precautionary principle and the scientific uncertainty will certainly make it hard to pass all the clinical trial and get the marketing authorization. But nothing seems to clearly forbid its commercialization.</li>
 +
                </ul> </p>
 
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             <div class="block title" id="Three"><h3 style="text-align: left;"></h3></div>
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             <div class="block title" id="US"><h3 style="text-align: left;">Glimpse of the American regime</h3></div>
 
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             <div class="block full">
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                 <p>In the context of the human practices we also wanted to study how people perceive synthetic biology, GMOs and our project. We decided to create a survey using the Google Form Platform. However, we had to pay close attention to the General Data Protection Regulation (GDPR), which is applicable since May 25th, 2018.To conform to the GDPR, we made sure that:
+
                 <p>In the USA, medical devices are regulated since 70s, within the recommendations of the Cooper committee. However, the Medical Device Regulation Act was first introduced in May 1976.</p>
−
                     <ul style="text-align: left;">
+
                <p>In order to be lauched on the market, medical devices need an authorization of the Food and Drug Administration (FDA).</p>
−
                        <li>Those polled were informed about the aim of our study and the use of the data they would give.</li>
+
                <p>The classification is a bit different from Europe. Indeed, there are 3 classes : class I, class II and class III with different procedures : premarket notification; premarket approval and product development protcol.</p>
−
                        <li>Those polled accepted or refused the use of their answers in the context of the survey and of the iGEM competition. They had two options: they could agree to the data collection and analysis or refuse. In the case of a refusal, they would not be able to answer the survey. These boxes were the way we chose to attract their attention on the data collection.</li>
+
                <p>For class III products, there are 4 steps : <br>
−
                        <li>We only asked for data that were significant and genuinely useful to our study. </li>
+
                     <li style="text-align: left;">examination of the administrative admissibility of the request </li>
−
                     </ul>
+
                    <li style="text-align: left;">scientific and statutory analysis of the manufaturer’s quality system</li>
 +
                    <li style="text-align: left;">examiniation by an advisory committee (if requested)</li>
 +
                     <li style="text-align: left;">deliberation and decision </li>
 
                 </p>
 
                 </p>
−
                 <p>Indeed, article 4 of the GDPR defines personal data as “<i>any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person”</i>.We then tried to ask for pieces of information that were relevant to our study and we made sure that those polled were not identifiable through collected information. We asked for gender, age and scientific background for the French survey (and the nationality for the international survey). Those pieces of information, as they do not allow us to identify a person, or not considered as personal data. </p>
+
                 <p>Once this procedure is fulfiled, the premarket authorization (PMA) is granted, and every modification of the product must be approved by the FDA. </p>
−
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+
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            <div class="block title" id="Four"><h3 style="text-align: left;"></h3></div>
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                <p>Apart from ethical questions surrounding personal data and human research, questions have also been raised concerning our lab experiments using neuronal cells. Indeed, one important component of our experimental part included the establishment of a model for the interface of our biofilm with neurons. We initially planned to perform dissection of dorsal root ganglia from E18 rats to obtain primary neuronal cells which would be placed in culture. The impact of our biofilm would then be studied in providing growth factors.However, within our team, we raised the question of whether there was a better way to have access to neuronal cells. Which lead to a discussion about dissection in general. </p>
+
−
                <p>We decided to include this theme in the Parisian Meetup we organized. The Parisian Meetup of 7th July 2018 was composed of two parts, one was dedicated to a rehearsal session of all teams, and the second part was dedicated to round tables about ethics in biology. Each round table was composed of 1 speaker and around 10 team members. We invited people from animal rights, National animal well-being committee, law, ethics education, and human evolution forecasters, allowing each team members to discuss and exchange their opinions about ethics in biology and science in general. </p>
+
 
             </div>
 
             </div>
  
−
             <div class="block title" id="Five"><h3 style="text-align: left;">What is the role of ethics in research? </h3></div>
+
             <div class="block title" id="US"><h3 style="text-align: left;">Conclusion</h3></div>
 
             <div class="block full">
 
             <div class="block full">
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                 <p>As simple as it might appear, this question is in reality, a very wide and tricky one. We asked Dr. Odile Gelpi about this question. One big role of Ethics in the field of science is the question of the balance between risks and interests. Indeed, as noted by Mrs. Gelpi, “scientific knowledge cannot be acquired at any cost”. It is also important to note that ethics is closely related to culture. Although it exists international ethical principles applied almost everywhere, some rules or point of views can differ. For example, when talking about balance of interest between risks and interests, the issue of this balance can differ according to whether you analyze the interest from the point of view of the patient as an individual or from the point of view of the society, who could benefit from this research. The topic of ethics is a tricky subject, which needs the gathering of different points of view to be analyzed in the best way.</p>
+
                 <p>Even though medical devices have been set aside for a long time, scientific advances are making them more and more complexe with new questions raised. However, law is unfortunately a field of study that is continuously chasing after new technologies. Indeed, law often reacts specificaly to new technologies and techniques. In the case of medical devices, law is trying to build a broad framework in which all medical devices can fit. Unfortunately, some questions, as they are not specificaly regulated, do not have fixed answers, or at least, not until the case is faced. </p>
 +
                <p>In the end, we cannot state whether the NeuronArch device will be able to enter the market, however, no laws seems to be against it. </p>
 
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Revision as of 13:46, 8 October 2018

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Regulation concerning medical devices

A new legal framework for medical devices ?

As the iGEM Pasteur Paris 2018 team is developping a new type of bionic prosthesis using a genetically modified biofilm, whose aim is to act as an interface between the human body and the machine, we were wondering how it would be regulated and which legal regime would be applied. We asked ourselves: is the actual legislation sufficent to oversee the different aspects of the NeuronArch Project ?

For the purpose of defining the legal status of our medical device, we decided to first examine the evolution of the legal regime and the legal definition, then analyze the different questions that can be raised and finally have a glimpse of the american system concerning medical device regulation.

The legal regime of medical devices in France

Medical devices have been regulated quite recently. Indeed, as drug regulations exist since 1965 and have been harmonized in Europe, medical devices were not regulated until 1990.

The philosophical ideas behind regulating drugs and medical devices are quite different. Indeed, the strategy of « the new approach » was applied to medical devices. It was based on a mutual recognition. Thus, member states of the EU were forced to admit on their territory, medical devices that were meeting the state of origin’s standards.

Since this system was considered as having a too weak control on medical devices, a revision was made in 2007 in order to partially correct these weeknesses. However, the « Breast implant scandal » made the legislator realise that the « new approach system » was insufficient to ensure the safety of EU citizens.

The European Parliament regulation (EU) 2017/745 and of the EU Council of 5th April 2017 was adopted and its 2 main goals were : ”ensure smooth functioning of the internal market as regards medical devices” and the setting of “high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products”.1

The definition of a medical device in very important, as it has to determine which procedures have to be followed and which laws it falls under. A medical device is defined as « any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means »2 . This definition is conceived as a reverse definition of drugs.

As “medical device” is a very broad group of products, a classification exists and permits the application of different procedures, depending on the class of the product (class I ; class IIa ; class IIb ; class III). This classification is based on their potential to cause harm.

The regulation (EU) 2017/745 has permitted some changes, for example, in the classification, which changed our device from a IIb class to a class III device. It has also set up a « Unique Device Identification System » and the « Eudamed » database, which is a key aspect of the regulation.

Questions raised by the NeuronArch project

According to Regulation 2017/745, medical devices “shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety“.

We raised questions about some aspects of the NeuronArch Project, such as responsability, legal questions around the software that would be used together with our prosthesis, and the question of GMOs.

  • Responsability : obligations of the manufacturer (article 10 of Regulation 2017/745), obligations of the importers (article 13 of Regulation 2017/745), obligations of the distributors (Article 14 of Regulation 2017/745), manufacturer’s obligations applied to importers, distributors or other persons (Article 16 of Regulation 2017/745) .
  • NeuronArch App : new obligations born from the statut of the software, depending on whether considered or not as a medical device.
  • GMOs : can we launch a medical device inserting GMOs in human body ? The precautionary principle and the scientific uncertainty will certainly make it hard to pass all the clinical trial and get the marketing authorization. But nothing seems to clearly forbid its commercialization.

Glimpse of the American regime

In the USA, medical devices are regulated since 70s, within the recommendations of the Cooper committee. However, the Medical Device Regulation Act was first introduced in May 1976.

In order to be lauched on the market, medical devices need an authorization of the Food and Drug Administration (FDA).

The classification is a bit different from Europe. Indeed, there are 3 classes : class I, class II and class III with different procedures : premarket notification; premarket approval and product development protcol.

For class III products, there are 4 steps :

  • examination of the administrative admissibility of the request
  • scientific and statutory analysis of the manufaturer’s quality system
  • examiniation by an advisory committee (if requested)
  • deliberation and decision

    • Once this procedure is fulfiled, the premarket authorization (PMA) is granted, and every modification of the product must be approved by the FDA.

    Conclusion

    Even though medical devices have been set aside for a long time, scientific advances are making them more and more complexe with new questions raised. However, law is unfortunately a field of study that is continuously chasing after new technologies. Indeed, law often reacts specificaly to new technologies and techniques. In the case of medical devices, law is trying to build a broad framework in which all medical devices can fit. Unfortunately, some questions, as they are not specificaly regulated, do not have fixed answers, or at least, not until the case is faced.

    In the end, we cannot state whether the NeuronArch device will be able to enter the market, however, no laws seems to be against it.