Counterfeit products pose significant and potentially life-threatening risks to the health of patients. Such products may lack active ingredients so patients do not receive the treatment they expect and need, or they may contain other ingredients that could pose a safety risk.
The production of counterfeit products is increasing but there are no confirmed figures on the exact extent of the problem. In the Chinese market, we have known of counterfeiting for years. Elsewhere globally, we are aware that the problem is increasing. The increase in diabetes prevalence, poor access to affordable insulin and price variations in developing countries, make the market attractive to counterfeiters thus increasing the risk in low- and middle-income countries.
To ensure patient safety, we have been implementing a comprehensive anti-counterfeit programme. A cross functional Anti-Counterfeit Working Group, chaired by the head of our Customer Complaint Centre, ensures vigilant risk assessment and implementation of an Anti-Counterfeit Product strategy.
We have an ongoing international collaboration with regulatory bodies, scientific and trade organisations, law enforcement agencies and other stakeholders to investigate counterfeit products and to influence legislation regarding new anti-counterfeit measures.
Those found guilty of producing or/and distributing counterfeit Novo Nordisk products are given fines and/or custodial sentences. China, as a result of lobbying and official intervention, has increased the length of sentences for counterfeiting.
We are a member of the Pharmaceutical Security Institute (PSI), which on behalf of the approximately 30 largest pharmaceutical companies, collects information and coordinates investigations into counterfeit products worldwide.
We conduct regular reviews of risks through information exchange with external collaborators. The investigation of suspected counterfeit cases is reported via our affiliates or authorities. Monthly internal counterfeit surveillance reports are reviewed by key specialists and management.
Our Quality Management System identifies and investigates alleged occurrences of counterfeited Novo Nordisk products. In China, we work with local investigation firms to perform market searches to help health authorities track down and seize counterfeit products. Outside China, we conduct investigations of suspected counterfeit products based on risk analysis and take legal action against those involved in the counterfeiting of our products.
When investigations confirm cases of counterfeit products, we communicate in a timely and open way to minimise the safety risk that the use of such products may pose.
Recognising that low awareness and under-reporting are known issues in many countries, we provide internal video training for our affiliates globally. We also provide a video for the public to raise awareness. The video urges patients to buy Novo Nordisk products from legitimate sources only and to report suspected counterfeit products.
Customer Complaint Centre tracks and analyses a number of indicators including:
For the high-risk products known to be subject to counterfeiting in China, the development in sales and reported adverse events are also evaluated.
In China, our proactive approach including collaboration with and training of local authorities, and scouting for counterfeit products and reporting these to local authorities has enabled us to keep Novo Nordisk counterfeit products at a relatively lower level.
Currently, the main products being counterfeited are NovoFine® in China and Norditropin® sold via the internet or in fitness centres.
The public, including patients and healthcare professionals, can raise concerns of suspected Novo Nordisk counterfeit products to us as a customer complaint, which will be investigated by our Customer Complaint Centre and relevant experts.