A New Law for Vaccine Manufacturers Supplying Vaccines to China

In an effort to combat the recent chaos around the quality and standards of vaccines, the national legislative body of the People’s Republic of China, the National People’s Congress, adopted and announced The Vaccines Administration Law (“the Law”) on June 29, 2019. It comes into effect on December 1, 2019 and implements stringent management rules for vaccine quality, incorporating strong protections for human safety.

Under the Law “vaccine marketing authorization holders” will be responsible for the safety, effectiveness and good product quality of a vaccine throughout the whole lifecycle of the licensed product. This means their responsibility is sustained throughout the entire process from vaccine development, production and distribution, through to and including vaccinations themselves. 

This is a major change. Prior to this law, risk management of vaccines in China relied on the supervision of the regulatory authorities, with vaccine companies playing a relative passive role throughout the chain. These changes mean the main responsibility for risk management is transferred from the governmental regulatory bodies to vaccine companies.

Importantly, the Law contains some compulsory liability insurance provisions, with potential different insurance requirements and regimes for compulsory and voluntary vaccine types.

Implications

If your company supplies vaccines – in either the compulsory or the voluntary category, you need to understand what insurances you need and how best to arrange them to meet the requirements of this new Law. 

How Marsh can help?

We are monitoring the situation and the legal developments.

We have a firm view as to the insurances manufactures/marketing authorization holders should purchase, and how to calculate the limits they should buy in order to protect both themselves and the users of their products in China.

We have provided advice and solutions to Life Sciences clients in China and believe we are best placed to provide a right-sized solution, depending upon your geographic reach and exposures under this new law. We look forward to being able to help you navigate these changes so your business can continue to thrive.