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Radiation liability insurance

How to insure clinical studies with radioactive substances or ionizing radiation

Clinical trials are necessary in order to test non-approved drugs or new medical devices. In our series on relevant insurance cover for clinical trials, following Part 1, "Insurance for test subjects" and Part 2, "Travel accident insurance", we would now like to turn to "radiation liability insurance" This is taken out with an AMG or MPG-approved special liability insurer - usually with the help of a special insurance broker like us as your risk partner.

1 What does radiation liability insurance cover?

Radiation liability insurance is required by the Federal Office for Radiation Protection (BfS) as part of a separate approval or notification procedure for clinical studies in which the use of radioactive substances or ionizing radiation on humans is intended in accordance with the Radiation Protection Act (StrlSchG) or the X-ray Ordinance (RöV).

The insurance cover applies if a claim is made against the sponsor / CRO on the basis of statutory liability provisions under private law due to damage that resulted in the death, injury or damage to the health of the volunteer or patient.

Due to frequent downstream damage, a long follow-up reporting period (at least 10 years) must be ensured.

2. why is test person insurance not enough?

The volunteer insurance does not cover damage to the health of volunteers/patients if it occurs within the clinical study as a result of the study-related use of radioactive substances or ionizing radiation on humans for the purpose of medical research. As one of many points, this requires separate approval from the Federal Office for Radiation Protection (BfS).

Nevertheless, it makes sense - especially if the volunteer insurance is mandatory - to coordinate these two types of cover. As the test persons/patients already receive a certain amount of cover for damage to health through test person insurance, radiation liability insurance should only offer additional insurance cover. This is referred to as supplementary radiation liability insurance, which is economically superior to full radiation liability insurance.  

Premium drivers from the perspective of the test person insurance

Risk factors of the proband insurance

From a risk management perspective, it is essential to create a common risk awareness in the first step, which is largely supported by the risk strategy. Convince your investors in the due diligence process of your next financing round with a risk report and a deep understanding of your risks, thereby safeguarding against risks that could threaten your company's existence.

On the basis of sound risk and insurance management, we develop a decision-making basis for your company. You decide what to insure and what not to insure. Because not every risk is worth insuring. Here is our basic approach:

  • Risk identification in joint risk workshops, coupled with our experience in industry-typical risks for life sciences, FinTech, tech companies and venture capital firms
  • Risk analysis and assessment (software supported on request)
  • Development of a joint risk management strategy (Which risks can be accepted, avoided, reduced or transferred?)
  • Determination of your company's risk-bearing capacity and risk acceptance and impact analysis on KPIs in your balance sheet (how much risk can you afford or do you want to take?)
  • Creation of an insurance strategy (what risk should be borne by the company, what should be insured? Goal: Minimization of risk premiums)
  • Implementation and placement of risk and insurance strategies on the insurance market

 

Your added value through active risk and insurance management:

  • Sustainably increase the security level for your company
  • Value-oriented risk management will boost your valuation in the next financing round
  • Significantly reduce your insurance costs
  • Manage and process claims more efficiently
  • CONSCIOUSLY take risks and promote growth!

 

The importance of this for young growth companies was demonstrated not least by the Silicon Valley Bank case, which was identified as part of a risk management process and - if necessary - would have led to an adjustment of the banking/treasury strategy.

(1) Anyone who uses radioactive substances or ionizing radiation on human beings for the purpose of medical research shall require approval, unless the use of radioactive substances or ionizing radiation on human beings for the purpose of medical research is subject to notification pursuant to Section 32 (1). Approval is also required for anyone who deviates significantly from an application approved in accordance with this provision.

(2) The application for approval shall be accompanied by the documents required for examination.

(3) The competent authority shall check the documents required for the examination for completeness within 21 calendar days of receipt of the application for approval. If the documents are incomplete, the competent authority shall request the applicant to rectify the deficiencies it has identified within 21 calendar days of receipt of the request. The competent authority shall decide on the application for approval within 90 calendar days of receipt of the complete application documents. The competent authority may extend the deadline by 90 calendar days if this is necessary due to the difficulty of the examination. The extension of the deadline must be justified and communicated in good time. The permit shall be deemed to have been granted if the competent authority has not made a decision on the permit application within the extended period.

(4) The competent authority may only grant approval if

  1. the radiation-related risks associated with the application for the person included in the research project are medically justified in terms of the anticipated significance of the results for the further development of medical examination methods or treatment procedures or medical science, taking into account the medical benefit for the person, if applicable,
  2. the radioactive substances or types of application of ionizing radiation intended for medical research correspond to the purpose of the research project and cannot be replaced by other types of examination and treatment that result in no or less exposure for the person,
  3. the exposure occurring during use and the activity of the radioactive substances to be used cannot be further reduced according to the state of the art in science and technology without jeopardizing the fulfilment of the purpose of the research project,
  4. the number of persons included in the research project is limited to what is necessary to fulfill the purpose of the research project,
  5. an ethics committee has issued a favorable opinion on the research project in accordance with Section 36,
  6. the applications are supervised by a physician who has the required expertise in radiation protection and at least two years of experience in the application of radioactive substances or ionizing radiation to humans,
  7. the necessary provisions have been made for the fulfillment of statutory compensation obligations and
  8. an authorization according to § 12 paragraph 1 numbers 1 to 4 for use on humans exists or the operation of an X-ray device notified for use on humans according to § 19 paragraph 1 is permitted.

(5) The provision for the fulfillment of statutory compensation obligations within the meaning of paragraph 4 number 7 shall be made for the period from the beginning of the application until the expiry of ten years after the end of the research project. Paragraph 4 number 7 shall not apply insofar as the requirements of the Nuclear Insurance Cover Ordinance are fulfilled in terms of reason and amount by the provision made to meet statutory compensation obligations in accordance with the corresponding provisions of the Medicinal Products Act or the Medical Devices Implementation Act.

(6) If the application provides for the use of radioactive substances or ionizing radiation in several facilities (multi-centre study), the competent authority shall grant a comprehensive authorisation for all facilities for which the requirements pursuant to paragraph 4 numbers 6 and 8 are fulfilled.

(7) The competent authority shall send a copy of the approval notice to the supervisory authority responsible for the research project.
 

1) In the approval procedure, the administrative authority shall determine the type, scope and amount of the provision for the fulfillment of statutory compensation obligations (cover provision) to be made by the applicant. The determination shall be made every two years and again in the event of a significant change in circumstances; in doing so, the administrative authority shall set a reasonable deadline for the party obliged to provide cover, within which the cover must be proven.

(2) The precautions referred to in paragraph 1 must
  1. in the case of installations and activities for which liability is determined in accordance with the Paris Convention in conjunction with Article 25 paragraphs 1 to 4, Article 25a, one of the international treaties referred to in Article 25a paragraph 2 or Article 26 paragraph 1 in conjunction with paragraph 1a, be proportionate to the hazardous nature of the installation or activity; where liability is determined in accordance with the Paris Convention in conjunction with Article 25 paragraphs 1 to 4, the financial security may not be less than the amounts specified in Article 7 paragraphs a and b of the Paris Convention,
  2. in other cases of an activity that requires authorization on the basis of this Act or on the basis of an ordinance issued under this Act, ensure the fulfillment of statutory compensation obligations to the extent required by the circumstances.
 

(3) Within the framework set out in paragraph 2 and in order to achieve the purposes set out in section 1, more detailed provisions may be issued by statutory order on the measures required to provide for the fulfillment of statutory compensation obligations. In this context, the amount of the financial security shall be regulated within the framework of a maximum limit of EUR 2.5 billion; the maximum limit and the amounts of cover shall be reviewed every five years with the aim of maintaining the real value of the financial security.

(4) The Federal Government and the Länder shall not be obliged to provide cover; this shall apply mutatis mutandis to the third party pursuant to Section 9a (3) sentence 2, second half-sentence. Insofar as a Land is liable under the Paris Convention in conjunction with section 25 (1) to (4), under section 25a or under one of the international treaties referred to in section 25a (2), the licensing authority shall determine, applying subsections (1) and (2) and the statutory order issued under subsection (3) mutatis mutandis, to what extent and in what amount the Land shall be liable for the fulfillment of statutory compensation obligations without coverage by the indemnification obligation under section 34. This obligation to assume liability shall be equivalent to the provision of cover when applying this Act. Sentences 2 and 3 shall not apply to the Federal Government.

(5) Statutory obligations to pay damages within the meaning of this Act are obligations to pay damages based on statutory liability provisions under private law. Statutory compensation obligations within the meaning of this Act do not include obligations arising from Sections 110 and 111 of the Seventh Book of the German Social Code, obligations to indemnify arising from Section 7 (6) of this Act in conjunction with Section 14 of the Federal Immission Control Act, and similar compensation or indemnification obligations only to the extent that the damage or impairment was caused by an accident.
 
Source: https: //www.gesetze-im-internet.de/atg/__13.html
 

Good Clinical Practice (GCP) is an internationally recognized ethical and scientific standard for the planning, conduct, documentation and reporting of human clinical trials. Compliance with this standard creates public confidence that the rights, safety and welfare of the subject will be protected in accordance with the principles set out in the Declaration of Helsinki. Measures must also be taken in the event of harm to the trial participant as a result of the clinical trial. This is ensured by taking out the right insurance and by providing additional health care.

"Together with our new subsidiary "Atrialis GmbH: experts in clinical trial insurance", we are one of the market-leading specialists and can provide you with competent support in the risk structuring and transfer of complex international studies as well as in the event of a radiation liability insurance claim thanks to our many years of experience."

3. what does radiation liability insurance cost?

Team Risk Partners is currently compiling examples from our customer base on the costs of radiation liability insurance and supplementary radiation liability insurance for you.

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