Three major groups representing pharmaceutical companies doing business in Japan are pushing back publicly at what they call plans by regulators to impose onerous new price controls and regulations that would make it harder for them to bring much-needed drugs to market, innovate new treatments, and gain approval of products already in the pipeline.
The three groups, – Japan Pharmaceutical Manufacturers Association (JPMA), Pharmaceutical Research and Manufacturers of America (PhRMA), and European Federation of Pharmaceutical Industries and Associations (EFPIA) are united in opposing key elements of the pricing revisions the country’s Central Social Insurance Medical Council (Chuikyo) began discussing in April.
Specifically, the groups are calling for an exemption for new drugs from Japan’s regular price cuts, saying the price controls hamper innovation and make it harder for drug companies to recoup development costs.
The groups also are publicly asking Japanese regulators to limit a new practice, announced by Japan’s Ministry of Health, Labor and Welfare (MHLW), to evaluate and revise prices paid for pharmaceuticals by the National Health Insurance system (NHI) annually. Until recently the policy of conducting evaluations and revisions every two years had been enshrined in Japanese law.
And blaming the slow rollout of COVID-19 vaccines in Japan on outdated clinical and regulatory requirements, the industry groups called for speeding up drug approval processes.