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Healthcare
Industries and Products

  • Galerie

    Defending Your Products and Reputation

    Limit the risks and impact of recalls and product liability disputes

    We work in conjunction with specialists in crisis communication to avoid excessive media coverage of any adverse or recurrent adverse events.

    Our extensive experience in this area has allowed us to develop industrial management applications and processes to handle large-scale cases.

    We have developed a unique system to ensure absolute confidentiality if you choose to settle out-of-court, which we have called ‘Savoir Etouffer un Accord’ (Keeping Settlements a Secret).

    Week after week we represent clients before the courts and commissions for conciliation and compensation for medical accidents (CRCI), thus regularly contributing to the growing body of case law.

    We are also active contributors to the legislative process, and are working to limit the consequences for the industry of the plan to allow class actions in medical cases currently being considered by Parliament.
  • Galerie

    Regulation of the industry

    Regulatory issues never seem to end … here are just a few examples:

     
    • Streamlining a diversified group, factoring in pharmaceutical constraints, the wide variety of products, and the status of sales and marketing workers
       
    • Division of responsibilities between Pharmaciens Responsables / Qualified Persons in a group of companies,
       
    • Training of medical professionals in an innovative environment, via a corporate foundation
      We can help you to set up a corporate foundation and advise on any necessary adjustments, quite simply because we have done this in the past.
       
    • Setting up a website for the general public that will help you to stand out from your competitors
      We are acknowledged specialists in medical product advertising, and fully understand the blurred line between institutional communication and promotion. We can help you to find the right words: words that will have an impact but that will remain within the law. Your website will stand up to the test.
  • Galerie

    Distribution, partnership and sponsorship contracts

    Sell more, better, anywhere


    We have reorganized distribution networks in Europe, South America, Scandinavia, North Africa and French-speaking Africa.
    We provide this service in conjunction with approximately one hundred tried and tested foreign correspondents, who are all specialists in medical products.
    We can organize the reintegration into your company of marketing authorizations you may have had to assign to local distributors.
    We are in the process of setting up the first selenite drug distribution network for an international group, which will be operational by 2016.

     
    • Assistance with export and marketing within and outside the EU, in conjunction with a very dense network of specialist correspondents
       
    • Coordination of international projects (involving up to 92 countries)
       
    • Distribution agreements involving any country
       
    • All types of partnership agreements
       
    • Sponsorship /co-sponsorship / co-marketing agreements
  • Galerie

    Don’t litigate, mediate

    Settle a dispute with a partner quickly and rebuild your business relationship

    As CMAP*-trained mediators, we propose mediation when appropriate and can convince even the most reluctant parties to try it.

    Mediation means (i) you can bring an end to a dispute without excessive expenditure and in just a few weeks, and (ii) you can maintain and even at times improve your relationship with your partner.

    Although it may not be good for our billings, it is good for you.


    * CMAP = Mediation and Arbitration Center
  • Galerie

    ‘Border-line’ products

    Market a product with different classifications throughout the European Union

    Our dual expertise in the promotion of medical products and in classification issues means we can help you to come up with the right strategy.

    Use convincing nutritional and health claims for your new range of ‘healthy’ products

    We advise importers, distributors and a TV shopping channel; we have extensive experience in the classification of border-line products and health claims.
     
    • Classification of border-line products
    • Choice of authorized health claims
    • Advice on restricted promotional and marketing practices.
  • Galerie

    Pricing & Reimbursement, tarification, (re)evaluation

    Launch an innovative medical solution, and change classification and tarification

    Our teams are experienced in handling campaigns that combine legal action and lobbying in order to change an out-of-date product classification as determined by UNCAM*.

    * UNCAM = National union of State health insurance agencies

    Capitalize on a classification re-evaluation

    Having contributed to it extensively, we are very familiar with the case law of the Conseil d'Etat, and with its accelerated appeals process; this means we can point you towards pragmatic business solutions and away from lengthy proceedings whose outcome is impossible to predict.
  • Galerie

    ‘Safety’ and 'Supply' Contracts

    Update your 'Safety' contracts

    Nobody else seems to know what they are, do they?
    We know, and in the past two years we have updated and overhauled a large number of safety contracts in both French and English.
    • Updates requested by the ANSM*
    • Redrafting of pharmacovigilance/medical device vigilance agreements in conjunction with distributors

    * ANSM = French national drugs administration
  • Galerie

    Anti-Gift and Transparency Laws; Compliance

    Reconcile Ethics with Business

    We have advised on the wording of many internal charters concerning:
    - all types of relations with medical professionals and the authorities;
    - transparency.

    We know "what can be done" while complying with confidentiality obligations, and can advise you on how to respond in line with tacit accepted practice.

    We have a European vision of good practices in terms of promotion, anti-gift laws and transparency.
    We are one of the few firms in France or elsewhere to organize conferences on these topics, which are attended by specialists and service providers as well as representatives of the medical boards.
     
    Updating of internal charters and tools in line with the French Transparency Act
    Regulatory assistance in connection with the introduction of transparency tools
    Development of arguments in proceedings before medical boards
    Assistance during investigations by the DGCRRF* and criminal litigation


    * DGCCRF = Directorate General for Competition, Consumer Affairs and the Prevention of Fraud
  • Galerie

    Medical advertisingi, promotional and information campaigns

    React to a competitor’s advertising campaign

    Ask us to start emergency court proceedings to prohibit an advertising campaign, resulting in
                 - publication of the court order
                 - recall and destruction of illegal materials
                 - mailing of clarifications
                 - enforcement of court decisions

    ... and ultimately in the disruption of your competitor’s operations.


    We have represented clients in countless medical cases, and made a substantial contribution to the case law; in particular, we have obtained a number of innovative rulings on medical devices.

     
  • Galerie

    Biomedical research contracts

    Improve your relationship with associations of physicians and with medical practices

    Get to grips with medical board bureaucracy

    We can liaise on your behalf with national or local medical boards, and help you make the right decision despite often unjustified negative opinions.

    Nobody will know that you have consulted us, but your tripartite or other agreements with associations will satisfy the medical boards, meaning your clinical trial can go ahead.

    Under some circumstances, it is possible to legally contract with medical practices organized as private companies (société d’exercice libérale).

    We can also advise on the registration of medical professionals as self-employed.
  • Galerie

    Contracts with public-sector hospitals

    Develop your offer for hospitals


    In addition to medical products, comprehensive therapeutic solutions, training and maintenance services, public hospitals now also expect much more, and will try to push the legal boundaries to their limits: we can help you to establish just what those limits are.

    This will reduce the risks to which you are exposed with regard to competitors and the applicable legislation, including the risk of criminal prosecution. We do this by relying on tried and tested ‘best friends’ who have specialized knowledge of public-sector hospitals.
    • Assistance with tender procedures,
    • Choice of services that can be offered or proposed in addition to products and therapeutic solutions,
    • Precontractual interlocutory applications
  • Galerie

    Streamlining production

    Outsource manufacturing – Restructure your organization

    Our labor law teams are familiar with your culture and have a long-standing knowledge of the environment in which you operate, so you can rest assured that we will only propose solutions that are appropriate.

    We can help you to outsource manufacturing or production without your employees being up in arms.

    We specialize in handling employee transfers in compliance with the French Labor Codei, to achieve a smooth transition in a calm climate.

    Our approach to restructuring operations is similar to any other crisis situation: we will manage your voluntary lay-offs and job protection plans from A to Z, and will also guide and support your management teams through what is bound to be a difficult and stressful time.

    If need be, we can handle the full closure of a production site, including formalities with the authorities (Prefecture, DRIRE, DREAL*, etc.), while liaising with the appropriate specialists (communications, real estate, site decommissioning).


    * DRIRE = Regional Department of Industry, Research and the Environment
      DREAL = Regional Department of Planning and Housing

    Increase accountability and protect your managers

    We advise groups with highly complex structures on the reorganization of their corporate structure and delegations of authority.

    We draft powers of attorney for key managers.

    We develop systems to ensure that delegations of authority remain valid and relevant for an optimal period of time.
  • Galerie

    Transfer and storage of medical data

    Put in place a sophisticated automated transparent data collection and processing system when your parent company is dragging its heels

    Scaring your parent company by pointing out what criminal action it may face in the event of any breach of legislation in France does not scare us!
    For ‘fear leads to wisdom and compliance’.

     
  • Galerie

    Class actions in medical cases

    • Our firm has a long history of contesting accountability and challenging product liability claims involving all types of medical products;
       
    • Cooperating with image and reputation specialists to protect our clients during product recalls or legal proceedings is an essential part of our service;
       
    • With the emergence of class actions in France, our 20 years of experience in these two areas will prove invaluable.

    IT IS NO COINCIDENCE THAT YOU NEVER HEAR ABOUT OUR FIRM OR OUR CLIENTS IN THE MEDIA

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