Legal representation - Clemann Group

CLINICAL DEVELOPMENT IN EU

Every sponsor conducting a trial in the European Union (EU) and not having a registered office within the territory of the European Economic Area (e.g. from the USA or Japan or any other territory outside E.U.) is required by the European Union Commission through its directive 2001/20/EC to work with a legal representative in one of those countries.

CLEMANN GROUP offers to be your legal representative in EU, and acts as a support for your project to ensure compliance with the requirements from both the EU Commission and the Health Authorities.

Each clinical trial requires a legal representative whom will act as the agent of the sponsor in the event that legal proceedings are initiated and instituted within the EU/EEA.

LEGAL POINTS TO CONSIDER

Why a legal representative ?

Companies which do not have a subsidiary within the European Union and wish to perform clinical research projects in this region must comply with statutory requirements to get Health Authorities agreements, sponsorships and support. CLEMANN GROUP offers the opportunity to be represented by an experienced and authorized structure for its foreign clients (out of EU) and comply with European Union directives: The Clinical Trials Directive 2001/20/EC requires that for all clinical studies with pharmaceuticals in the European Union a sponsor or a legal representative of the sponsor must be legally registered within the European Economic Area. The Medical Device Directive 93/42 EEC requires that for clinical studies with medical devices a manufacturer or an authorized representative is established in the European Union.

What are the obligations of a Legal Representative?

It must be an individual person or a representative of a corporate entity. It should be willing to act as the agent of the sponsor in the event of any legal proceedings instituted in the EEA. It must be established and contactable at an address in the EEA. It does not assume any of the legal liabilities of the sponsor(s) for the trial by virtue of the role of legal representative and does not therefore require insurance or indemnity to meet such liabilities BUT it can undertake some or all of the statutory duties of the sponsor in relation to the trial, in which case the legal representative would also be regarded as a co-sponsor and would then require insurance or indemnity cover.

What are the obligations of the represented structure?

In all cases, evidence should be provided with the application that the legal representative is willing to take on the role of legal representative and is established at an address in the EEA. For example, a copy of correspondence between the sponsor and legal representative on appropriate headed paper could be supplied, or a copy of a contract. Where the legal representative is also a co-sponsor, this should be separately recorded on the application form and details given of the allocation of sponsorship responsibilities. Evidence of insurance or indemnity cover should be provided.

Why CLEMANN GROUP?

We offer competent, flexible and cost-efficient representation services. Thanks to our collaborative orientation, we gather the most qualified and experienced regulatory experts to follow your project from the starting point: reducing time and resources waste.

Where does CLEMANN GROUP's services extend?

We can represent you in all member states of the European Union for your drug and medical devices trials, to enable the submission of your project to the European Competent Authorities and Ethics Committees.

GLOBAL DATA PROTECTION REGULATION IN EU

« The EU General Data Protection Regulation (GDPR) replaces the Data Protection Directive 95/46/EC and was designed to harmonize data privacy laws across Europe, to protect and empower all EU citizens data privacy and to reshape the way organizations across the region approach data privacy. »

The goals of the GDPR rules are

To give ownership and more control to people over their personal data
To provide businesses benefit from a level playing field and simplify business across EU and the 15 adequate countries

The Law applies to all EU Countries since 25th May 2018 and all companies, based in EU or outside EU, collecting or processing EU residents personal data must comply with GDPR rules.

CLEMANN GROUP offers to be your GDPR legal representative in each EU Country, and acts as a support for your project to ensure compliance with the requirements from 2018 reform of EU data protection rules.

LEGAL POINTS TO CONSIDER FOR GDPR LEGAL REPRESENTATION

Who are the GDPR stakeholders ?

The three main actors involved in GDPR scope are described as below:
1 – Data Controller (= The sponsor)
Companies sponsoring the data collection in view of automated processing (can be paper) e.g. Pharma or Biotech companies

2 – Data Processor (= The Clinical Research Organization)
Companies processing data provided by others, or collecting data on behalf of others e.g. CROs, software vendor, data hosting company, clinical site

3 – Data Protection Authority (DPA = The Authority)
Country specific Authorities controlling data protection and law application

What are the key principles of GDPR rules ?

1 – Requirements to manage adequately critical processes

Critical Processes (*) are inventory and then each critical process needs

to be filed in a central repository with deeper level of information including:
§ initial objective of the process, names of processors, do the data go out of the country, new goals of the process if any, etc. (Register of processes, or record of processing activities)
§ Informed consent needs to be more detailed and updated if necessary
A Data Protection Impact Analysis (DPIA) as detailed risk based document.

(*) Critical processes: data on healthcare, ethnicity, race, politics, trade union, religious beliefs, children, elderly or harmful people and any mass processing of personal information allowing profiling of people. One epidemiological or clinical study is a critical process.

2 – A Data Protection Officer representing the Controller or Processor in each Country he is operating

In case the controller or processor, « as a core activity monitors individuals systematically and on a large scale, or that process special categories of personal data on a large scale », a Data Protection Officer (DPO) needs to be identified.

The DPO requires 3 hard skills :

IT and Data Management,
Health Science Business,
Regulatory knwoledge

A DPO can be an external consultant and be shared by several organizations.

The major roles of a DPO are to

Carry out DPIA and audits
Monitor compliance
Contact person for DPAs, Data Subjects, sub-contractors, data controllers
Update documentation and procedures

The DPO must be independent from data processes and easily contactable by Citizens. Indeed, Data breaches need to be notified to local DPA (and to citizen if high risk) within 72 hours. A citizens’ request needs to be answered within one month – in native language (subject access requests). Communications must take place in each country specific/applicable language used by the DPA and Data Subjects. The contact details of the DPO need to be published by Controller and Processor (the name is not required)

Why CLEMANN GROUP?

CLEMANN GROUP offers the opportunity to be represented by an experienced and authorized structure for its clients and comply with GDPR rules.
We offer competent, flexible and cost-efficient representation services. Thanks to our collaborative orientation, we gather the most qualified and experienced regulatory experts to follow your project from the starting point reducing time and resources waste.

Where does CLEMANN GROUP's services extend?

We can represent you in all member states of the European Union for your drug and medical devices trials, with local DPO able to communicate with citizens in local language to address data privacy questions and requirements.