MAP France Demo

Public Affairs in France

Public Affairs in France

Palais_Luxembourg_Sunset

Palais du Luxembourg

What is Public Affairs?

Public affairs involves the deliberate communication of relevant information between interested parties and their political representatives. People who work in public affairs are also sometimes known as lobbyists.

As part of their day-to-day activities, a public affairs practitioner uses a range of different tactics and strategies in order to make effective use of the available information to influence political decisions on behalf of their own organisation or a client.

Someone working in a public affairs could undertake a number of activities such as spending time following a particular debate in a legislature, doing some desk research on the opinions of a relevant politician on a particular issue, briefing a client or colleague for a meeting with a politician or meeting and briefing a politician themselves.

Executive and Legislative Powers in France

Summary 

The French Political system is a semi-presidential system which is also known as the Fifth Republic. In France the President of the Republic is elected for five years by direct vote.………………………………………….Join MAP to find out more

Executive

Together with the President of the Republic, the French Government (Government of the the French Republic) holds the executive power in France. The Government is led by the Prime Minister who leads both the junior and senior ministers. In France, senior ministers are referred to as Ministers and the junior ministers are called Secretaries of state..………………………………………….Join MAP to find out more

Legislative

In France, the legislative power is provided by a bicameral parliament, the National Assembly and the Senate..………………………………………….Join MAP to find out more

Clinical Studies in France

Clinical Studies in France
french-flag

France

For investigational Devices and for CE marked devices, applications are made though a centralised, electronic system DEDIM.Submissions must be made to AFSSAPS (through DEMIM) for both Competent Authority and Ethics Committee approval. Often approval is given within 60 days although this is variable depending on the device classification and it can be quicker for lower risk devices.

In France there are a couple of other approvals/ declarations which are required..………………………………………….Join MAP to find out more

DEDIM

DEDIM is a central electronic system for managing applications and is very similar to that used in the UK (IRAS) except for the fact that it is used only to apply for ..………………………………………….Join MAP to find out more

Ethics

There is a list of authorised Ethics Committees and it is advisable to choose a committee which is in the region of the Principal Investigator. If you receive ethics approval in France then this approval is valid across all French sites.

Unlike the UK, the meeting dates tend to be variable, as do the the frequency of these meetings and the submission dates, although the best way to keep on..………………………………………….Join MAP to find out more

The Law and Clinical trials

The Law states that biomedical research relating to a medical device or in vitro diagnostic medical device can only be set up after you have received a favourable notification from the CPP and also authorisation from ANSM

Reference: L.1121-4 article of the law of public health of the code of public health.

  • Before beginning the trial what must I have in place?
  • Which parts of the submission to the ANSM must be in French?
  • Who deposits the dossier?
  • What if the Sponsor is outside of France?
  • When should the dossier be submitted?
  • What can the ANSM request?
  • What if I have approval but need to modify my trial before beginning the research?
  • Do I need to notify anyone about starting my research?
  • What are the responsibilities of the investigator in the case of adverse events?
  • What are the responsibilities of the sponsor in the case of adverse events?
  • What is the role of the CPP in the case of adverse events?
  • Are there regulations about the protection of personal data of participants in the trial?

..………………………………………….Join MAP to find out more

First Placing in France

First Placing in France

french-flag

What is the definition of First Placing?

The French versions of Directives 90/385/EEC, 93/42/EEC and 98/79/EC define the “mise sur le marché” as “première mise à disposition à titre onéreux ou gratuit d’un dispositif”, whilst “mise à disposition” is defined in Regulation (EC) No 765/2008 as “toute fourniture d’un produit destiné à être distribué, consommé ou utilisé sur le marché communautaire dans le cadre d’une activité commerciale, à titre onéreux ou gratuit” (emphasis added).

When you place your medical device onto the market you need to communicate this with the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in accordance with the French law articles L.5211-4 and R.5211-66.

Of these two articles, article L.5211-4 of the code of public health provides all the information that is required to identify a medical device that you need to communicate to the ANSM when the device is put into service in the French market.

Article L.5211-4 and also decrees n°2002-1221 of 30 September 2002 and decree n° 2010-270 of 15 March 2010, represents sections of article 14 of European directive 93/42/EEC.

Do you need to have a distributor in the French region to place a device on the French Market? 

..………………………………………….Join MAP to find out more

Which Medical devices have to be communicated to the ANSM?

..………………………………………….Join MAP to find out more

What information must you communicate to the ANSM?

..………………………………………….Join MAP to find out more

 Who is responsible for communicating the first placing to the authorities?

..………………………………………….Join MAP to find out more

When should the communication be made?

 ..………………………………………….Join MAP to find out more

What about special cases such as devices that are manufactured using tissues or animal derivatives? 

..………………………………………….Join MAP to find out more

Where should the information be sent?

..………………………………………….Join MAP to find out more

Decision Makers in France

Decision Makers in France

  • Ministry of Health

  • French National Agency for Medicines and Health Products Safety (ANSM)

  • French National Authority for Health (HAS)

  • National Association of Health Insurance Funds (UNCAM)

  • Economic Committee of Health Care Products (CEPS)

..………………………………………….Join MAP to find out more

Regional Health Agencies

The aim of the Regional Health Agencies (Agences Régionales de Santé, ARS) is to streamline the provision of care, this is done by:

  • implementing the policy public health services in charge of health at work, school and university health and maternal and child health
  • monitoring the health status of the region
  • monitoring compliance with the rules of hygiene and participating in the prevention and patient education
  • exercising, on behalf of the State, the health inspection missions and responding to health emergencies
  • assessing the training of health professionals and helping them during their installation
  • participating in the control of medical procedures and the delivery of health products
  • conducting regional programmes of health insurance, especially in risk management ..………………………………………….Join MAP to find out more

Screen Shot 2016-06-08 at 13.12.15

Click here to see the Regional Health Agencies Interactive MAPs

..………………………………………….Join MAP to find out about more decision makers in France 

Innovative Medical Devices and Diagnostics

Innovative medical devices and diagnostics

France

Before a dossier has been submitted to the HAS, the Direction of Healthcare Provision (DGOS), part of the Ministry of Health, can use some tools from clinical research into patient care to help the development of innovation.

1. Hospital Clinical Research Program (PHRC)

………………………………………….Join MAP to find out more

2. Support Program for Innovative Techniques (PSTIC)

………………………………………….Join MAP to find out more

3. Research Program for Healthcare System Performance (PREPS)

………………………………………….Join MAP to find out more

4. Pharmacoeconomic Research Program (PRME)

………………………………………….Join MAP to find out more

5. Repository of innovative procedure without the nomenclature (RIHN)

………………………………………….Join MAP to find out more

Innovation Package (Forfait innovation)

If the actual benefit assesses by the HAS is insufficient, a conditional proposal exists: “no but”. The innovation package concerns innovative products, MDs and procedures that have insufficient data to have a refund by the national insurance system, even so data show a potential interest for this innovative technology. The innovation package is ..………………………………………….Join MAP to find out more


Do you think there is something missing or wrong with this page? Please let us know by using this form and we will address any issues ASAP.