China, 21 November 2019:
Mundipharma strongly rejects the allegations in the Associated Press story dated 20 November, that Mundipharma acted in an improper or illegal manner. Mundipharma is fully committed to maintaining the highest standards of compliance. Mundipharma ensures high standards are maintained in its business through regular inspections by both internal and external consultants.
We are extremely disappointed that the Associated Press allegations appear to be based on documents and sources which the Associated Press would not share with Mundipharma. We asked Associated Press on many occasions to provide us with the information and documents they were relying on so that we could investigate and verify them. On each occasion they refused to do so and refused to provide any specifics regarding the time frames and locations of the alleged improper activities.
Mundipharma is currently assessing the accuracy and relevance of each of the 23 documents published yesterday by Associated Press and upon which Associated Press base their claims, by checking all those documents against their company archives. It is notable that one of the ex-employees interviewed admitted to altering company documents. Of the 23 documents published by Associated Press, our initial investigation reveals that the majority of the documents were not documents approved by Mundipharma. A few of the documents appear to be Mundipharma documents but do not appear to be reliable and relevant sources for the allegations that Associated Press makes, based upon them.
- One presentation (Low Addiction Risk 1) which is alleged to have been used in 2018 was not part of the company’s authorised training programme in 2018.
- A document containing information about peaks and troughs in blood levels (OxyContin’s ‘peaks and valleys) appears to have been tampered with and is not in the form approved and published by the company. Even so, and contrary to what Associated Press alleges, the document does not make any claims about controlled release products being less prone to risk of abuse than immediate release.
- The document used to support Associated Press’s allegation that Mundipharma treated GPM (“Good Pain Management”) as part of its marketing strategy is a document that was not authored by Mundipharma.
- While Oxycontin in China has been approved to treat moderate to severe pain for both cancer and non-cancer pain, Mundipharma strictly promotes its use for cancer pain only.
- We continue to investigate the accuracy and relevance of the other documents.
We also strongly refute the suggestion that the company instructed sales representatives either to procure patient data or to impersonate doctors by putting on white coats. The company never gave any such instruction and would never condone such activity.
Mundipharma has a robust internal compliance programme which has been developed and refined over many years. It has detailed policies and procedures to ensure that all its interactions with healthcare professionals, grants and donations, sponsorships and incentives are in full compliance with all applicable laws and industry standards. In addition, all our employees, including our medical and sales and marketing employees, are subject to extensive and continuous training on these policies and procedures, which is fully documented and recorded.
Both internal and external auditors carried out a full review of Mundipharma’s compliance programme in China in both 2017 and 2018. They found no evidence of any illegal activity and made some best practice recommendations to continue to enhance Mundipharma’s overall compliance program. As soon as we became aware of the Associated Press allegations in September 2019, we hired DLA Piper, the global law firm, to carry out a thorough and independent investigation. The investigation is ongoing, but they have yet to substantiate any of the Associated Press allegations.
It is also significant that Mundipharma has never received any report of diversion or abuse of OxyContin in China; and we note that Associated Press themselves say that China has not suffered from widespread abuse.
We will continue to investigate all the allegations made by Associated Press and, to the extent we find any violations of our policies, we are committed to taking whatever actions are necessary to ensure that we continue to operate at the highest standards. In the meantime, we will follow up with Associated Press to understand the basis for their allegations and to again request access to the extensive documentation they reportedly reviewed. We urge Associated Press to conduct a full review of their processes and sources and to reconsider their allegations.