Life Sciences Insurances
A lire dans La Tribune de l’Assurance du 1er février 2020, une analyse extensive du secteur de l’assurance pour les biotech (article qui cite SafeTrial):
Même si la sinistralité est faible, l’auteur y expose les difficultés du secteur:
-faible structuration des biotech
-petit nombre de compagnies d’assurances spécialisées
-grande difficulté à s’assurer en cas d’entrée au Nasdaq
-etc
L’organisation et surtout l’organisation des idées est vitale, notamment pour les entreprises innovantes que sont les biotech.
Comprendre les associations, les interactions entre les concepts va bien au-delà des classiques « présentations », « plans », « listes » habituels.
Surtout dans des organisations innovantes, bouillonnantes et collectives comme les biotech, qui unissent chercheurs, manageurs, financiers, opérationnels.
Formalisée en 1971 par le psychologue Tony Buzan, ce mindmapping ou « carte heuristique » (en français) permet :
-la prise de note
-des brain-storming efficaces
-la structuration d’un projet, la clarification des idées
-une visualisation ludique pour les tiers
Il s’agit en définitive d’un schéma, où le problème est inscrit au centre, et d’où rayonnent des branches et sous-branches.
Plus qu’un long discours, ou qu’un texte de 2 ou 3 pages, il offre bien un accès immédiat aux grandes problématiques des essais cliniques (réglementaire, éthique, organisationnel,..) !
Testez-vous, essayez la méthode :
-un simple paperboard ou une feuille A4 seront suffisants au début
-de nombreux logiciels gratuits (ex www.wisemapping.com)
-des consultants existent, capables d’assister votre entreprise à mettre ainsi en forme les fruits d’une réunion ou d’une présentation : Succès garanti !
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Many important details (languages, wording, ..) are necessary to pass the regulatory barriers, with variations according to the countries.
We suggest you look for professional help. You will save time to focus on your candidates and your research process.
Insurance of clinical trials is typically a liability insurance that is to say it protects against claims (= with financial demands), from patients, former patients, practitioners, authorities, etc.
In some countries (United States, Brazil, China for example), insurance is not compulsory;
Other countries, such as the United Kingdom, New Zealand and Finland, require subscribing to a local policy but without mentioning limits;
Others, like France or Germany, require insurance for all tests, the limits being specified in the policy.
Even if not compulsory, insurance can be unavoidable if required by the local Ethics Committees.
Limits are set:
-by patient (ex 600 000 euros)
-by protocol (= per test) (ex 2 000 000 euros)
– possibly “per aggregate” (eg 3 000 000 euros) reflecting the maximum amount that the company agrees to have to pay (for example over a whole year)
New molecules, very innovative or invasive medical devices, very original research methods …:
The insurer has an aversion to unexpected cases, which prevents it from referring to actuarial tables to rate the risk (or simply accept / reject it)
Or more precisely in ALL the languages of the country (ex French / Dutch in Belgium).
May times the certificate is issued 1 in English 2 in the local language.
Some countries / some committees are satisfied with the mere mention of the number of centers, others demand the list of centers, others the addresses: Legal needs unfortunately vary a lot from country to country.
Victims can submit their claim for 10 years from the end of the search.
In the US, biotech companies fill a demand for classic Liability (a bit the equivalent of the Medical Liability Insurance they already benefit from).
These 2 documents are the main pieces:
-The Protocol allows the insurer to examine the boldness of the research project and the quality of the methodology
-The Patient Information Letter (anyway mandatory) makes clear that the patient is correctly (and in simple words) warned. This is for the benefit of both the sponsor and the insurer.
– the insurer will also analyze the possible discrepancies between the 2 documents
In addition, the insurer obviously needs quantitative (number of patients screened) and qualitative data (countries chosen, number of centers, duration of study, quality of the CRO).