I can’t, I have got insurance!

The shopping list of the biotech/medtech CFO

Life hazards, companies without any turnover, fragile organizations: insurers don’t like lifescience firms! All the more reason to get organized …

1 What type of liability insurance?

The “medical” liability insurance of a medtech or a biotech must be carried by a specialized company, able to take into account the specific risks of the sector (raw material handled, laboratory conditions, medical devices in contact with the human body …):

Chubb, CNAHardy, HDI, QBE, AXA XL, Allianz AGCS, …

Product liability covers the financial consequences of marketing a defective product. As long as the biotech has not begun a phase-3 trial or a commercialization phase, it can probably limit itself to a much cheaper general liability policy.

2 Are we ready for t our future clinical trials?

Mandatory or required by ethics committees, clinical trial insurances are difficult to get, expensive and vary from country to country. They must stick to the evolution of the protocol. You will be better off hiring a specialized broker, who will select companies offering solutions regardless of the test country and provide certificates within short notice.

3 Are our premises properly insured?

Property insurance seems a trivial matter. However, biotech or medtech firms often share part of their premises (with a university, in an incubator, etc.). Sometimes they share their equipment or conversely use foreign property. Your insurer has to be informed and the policy adapted.

4 Are our key equipments insured, and how?

Key harware (HPLC, microscope, etc.) is expensive and valuable.

Especially when it is leased, it must be properly insured via a Boiler & Machinery policy (which, moreover, covers them for hazards called “internal breakdowns”).

5 Do we have a Cyber ​​coverage?

Viruses and other network intrusions can cripple business, causing it to fall behind, and most importantly, lead to the loss of research data, or the leakage of sensitive or confidential information.

Biotech / medtech can protect themselves with a cyber insurance policy, even if it is not easy to obtain in this industry.

6 How to insure our new American branch?

Funding, trials coordination, research, …: Very soon, start-ups are tempted to gain a foothold across the Atlantic. Property & Casualty insurance in the US has nothing to do with French insurance concepts. Besides, traditional French insurers are often unable or unwilling to extend their guarantees to US operations. In addition, there is the obligation to have a local US broker. However, solutions exist, allowing for a more secure global contract.

7 What about employees working abroad or traveling?

Subsidiary, congress, meeting, …: managers and researchers are called upon to move. Please secure these 3 aspects:

-their civil liability abroad (incidents of all kinds)

-their health costs (in the event of illness or accident in a country without extensive social security)

-their possible repatriation (in the event of illness or family problem)

8 What about group insurance plans?

From the 1st employee, medtech or biotech must in French legally offer:

– collective pension schemes (guarantees in the event of death, sick leave, disability)

– group health insurance (reimbursement of health expenses)

 to all its employees (and by considering the many special cases: long-term interns, doctoral students, staff made available by others, etc.).

If the company depends, which is often the case, on the Collective Pharmacy Agreement (CCN 176), the guarantees to be respected are wide and difficult to get from traditional companies.

9 What about the business owner?

Often the founder, the boss of biotech / medtech is on all fronts.

He should buy several tailored insurance tools:

– the job loss insurance (because, as a CEO, he will not get unemployment benefits)

– loan insurance, if he has to raise funds himself, in the initial phase

– key person insurance, which allows him for example to hire an interim manager if he is in bad condition

– his personal insurance (“prévoyance”), for the benefit of his family

– a D&O (Directors & Officers) insurance, in case he, as the manager, is sued.

10 Can we increase the confidence of our investors ?

They put money into the business, they want to make sure it will not spin out of control!

Investors will scrutinize whether the guarantee limits of the policies described above in point 9 are sufficient.

Moreover, in the event of an IPO (Euronext, Nasdaq), they will demand robust policies, with comfortable amounts, suitable clauses, underwritten by top-tier companies and able to protect themselves as board members.

Conclusion:

Lifescience is not just about pipeline and raising money.

Insurance management can prevent delays in clinical trials, make funders more confident, and help manage hazards.

Quelle assurance de responsabilité pour les biotech?

Les assurances responsabilité civile exploitation (RCE) et produit (RCP) ont en commun de couvrir les dommages causés à des tiers. Mais elles interviennent dans des circonstances différentes, selon que le sinistre est lié ou non à l’exécution des prestations de l’entreprise. 

Le problème se pose avec acuité pour une jeune biotech :

-Doit-elle souscrire une simple RCE (et donc considérer qu’elle n’est pas encore en mesure de se voir reprocher les conséquences de ses actions) ?

-Ou doit-elle souscrire une plus couteuse et plus difficile à obtenir RCP ?

-Quid notamment lorsqu’elle entre en phase clinique (phase2) ? Les matières qu’elle met en test doivent-elles être considérées comme des « produits » (soumis à RCP) ?

La différence n’est pas négligeable en termes de budget (en moyenne, de 1500 à 10000 euros HT de prime selon les cas) et bien sûr en termes de sécurité contractuelle.

La Responsabilité Civile Exploitation (ou RCE) est un contrat d’assurance qui couvre les préjudices subis par un tiers au cours de l’exploitation. La RCE est dictée par le Code Civil qui stipule que tous dommages causés à autrui doivent être réparés.

Ces dommages pouvant aussi bien être causés par :

Le dirigeant

Les salariés

Les produits et machines,

ou encore les sous-traitants

Les dommages peuvent être corporels, matériels ou financiers.

Ex : Une société organise dans ses bureaux une démonstration à destination de prospects. Un invité trébuche et se blesse. La société sera tenue pour responsable.

EX :A l’occasion d’un rendez-vous de travail dans un laboratoire partenaire, vous débranchez accidentellement le câble d’alimentation d’une HPLC.

La RCP couvre des dommages du fait même de l’activité ou de des produits (de son output). Il peut s’agir par exemple :

d’un bien remis par un client et endommagé au cours de la mission,

d’un client qui est victime d’une intoxication alimentaire,

d’un oubli ou d’un retard dans la réalisation de la prestation, avec une conséquence financière pour le client…

La biotech, qui ne « produit » rien (même en définitive en phase 2) que des résultats, ne peut être mise en en cause pour ses « produits » d’autant que :

            -la fabrication des échantillons éventuels sera confiée à un CRO lui-même assuré

            -la biotech se sera assurée en « assurance essai clinique »

Attention : l n’en serait pas de même si la biotech commençait à commercialiser (sous forme de licences, ou de conseil) des résultats partiels de recherche.

Toutes les règles ci-dessus seront bien évidemment différentes sur un essai US (où l’assurance Essais Cliniques relève d’ailleurs d’ une..RC).

En conclusion :

-tant que la biotech est en « phase R&D », elle doit s’assurer en simple RC Exploitation

-ce n’est que quand elle se rapproche de la commercialisation (à voir d’ailleurs en phase 3) qu’elle doit s’intéresser à l’assurance RCP.

-le conseil de son courtier restera en tout état de cause le bienvenu !

Quelles garanties pour les biotech?

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

Le mindmapping au service des biotech

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 !

Voir aussi sur Twitter

Looking for Biotech CFOs desperately

An explosion in the number of publicly listed biotech companies—in combination with these companies’ strong preference to hire almost exclusively from within the life sciences industry—has put intense pressure on the biotech CFO market. In short, the demand for CFOs with biotech companies’ ideal profile—high performers with a history of proven results and of sitting public CFO, IPO and biotech industry experience—simply outstrips supply. 

Read the entire Russel Reynolds analysis here.

Pass our “Clinical trials & insurance”test

Assess your practical understanding of clinical trials insurance 

Are you comfortable with?

If not, call your broker!

Results

Congratulation!   Either you already have a thorough experience of “clinical trials”, or you are ready to enter phase II ..

Hmm ..

 

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.

#1 Clinical trial insurance is a liability insurance

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.

#2 Clinical trial insurance is compulsory

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.

#3 Limits of insurance can be freely chosen by the sponsor

#4 There are limits of insurance per patient & per protocol

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)

#5 Some insurers refuse new molecules

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)

#6 Certificate has to be set in the language of the country

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.

#7 Certificate must list the addresses of the centers

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.

#8 In France, the Huriet law grants 10 years to introduce a claim

Victims can submit their claim for 10 years from the end of the search.

#9 In the USA, clinical trial insurance & liability insurance are equivalent

In the US, biotech companies fill a demand for classic Liability (a bit the equivalent of the Medical Liability Insurance they already benefit from).

#10 Protocol & Patient Information Letter are the sole documents needed by the insurer to quote

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).

 

finish

An Overview Of Top Clinical CROs

In ClinicalLeader, an interesting review (even if dated 2015) of top CROs.

 

Three facts are being highlighted:

 

-the number of M/A, building global leaders

-the urgent need for small CROs to specialize

-the strategic alliances signed between CROs and data analysis service companies

 

A more recent study (2017 but in fact updating a 2015 research) can be found at Outsourcing-Pharma, study limited to the US market.