The Swiss newspaper Neue Zuercher Zeitung is reporting that up to 4000 jobs at Novartis are expected to be cut or moved to Hyderabad over the next 12 months. This comes weeks after CEO Joe Jiminez told investors he intended to increase operating margins.
The Swiss pharma company recently issued an upbeat Annual Report, but financial performance did not live up to investors’ expectations. The company has been following a programme of restructuring since 2007, including the closure of 15 sites; however, in 2013 the company’s headcount rise by around 8000.
Many of the affected jobs are thought to be in the company’s pharmaceutical division, particularly in data management, although some back-office functions are also expected to be involved.
In this interview, Dr Arun Bhatt explains the context of recent developments in India, where a legal ruling has required all patients considering taking part in a clinical trial to have their informed consent recorded on video.
In the 9-minute interview, Dr Bhatt explains:
- How the idea of filming informed consent arose and how it came to be part of a legal ruling
- Practical aspects of filming the informed consent process
- Whether he expects any impact on patient recruitment rates as a result
- Whether this development might be taken up in other countries
This interview was conducted via Skype, so the audio quality might make it difficult to hear the entire conversation clearly. A transcript will be added to this page shortly.
The office of the Drugs Controller General India (DCGI) has issued a guideline on the audio-visual recording of the informed consent process.
This guidance follows a legal judgement late in 2013 stating that “in all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent is required to be done while adhering to the principles of confidentiality.” An administrative order confirmed that this should take place for all new subjects being enrolled in all clinical trials, with immediate effect.
The guideline reiterates the general principles of the informed consent process, and then details how audio-visual recording should be integrated. The videographer should be included as a member of the study team, and the potential participant would first need to give consent for the consent process itself to be filmed. During the filming, the identity and records of the participant should be kept confidential; the later use of any video evidence (eg, in a potential legal process) would rely on visual confirmation of identity. The draft guidance concludes with the requirement to preserve the audio-visual recording, along with other documentation, for at least 5 years after the completion/termination of the study, if it is not possible to keep it “permanently”.
Newspapers in India are reporting that the country’s Drug Technical Advisory Board (DTAB) has been having detailed meetings regarding the use of audio-visual recordings to document informed consent to take part in a clinical trial. The Times of India reported that the DTAB had given “its nod for incorporating the change and making it a law” while the Pune Mirror suggested that the mandate would be introduced “soon”.
“Digital consent, as much as it will safeguard the interest of a patient, will also make the process of counselling more transparent,” a senior government official told the Times of India. “This will ensure that no one is blindly made to sign some papers. More importantly, it will show how much the participants are informed about the possibility of failure or side effects.”
The idea initially arose to combat suggestions that patients were taking part in clinical trials without being adequate informed, let alone given the opportunity to consent, with at least one Indian CRO having its activity suspended while claims were investigated.
This is a topic that I wrote about in CRfocus almost a year ago, and which caused something of a furore on discussion boards such as LinkedIn. This piece explores some of the logistical issues that the Indian law-makers will need to consider, but concludes that, whilst filming informed consent “would not of itself make a well-performed consent process any better, it would make it more difficult to get away with conducting the process badly.”
In an interview with BBC India Business Report, the head of Novartis in India, Ranjit Shahani, suggested that pharma R&D investment in India will cease following the Supreme Court decision not to grant the Swiss pharma company a patent for its oncology drug Glivec. He explained that Novartis was “disappointed” by the court’s decision, and stressed that 95% of Indian patients prescribed Glivec receive it free of charge.
In the context of the interview, it is not clear whether Mr Shahani’s comments are a formal statement of Novartis’ intent to stop all R&D in India immediately (there is no mention of this on the Novartis website), or a more general “sea change” in industry sentiment towards the country, with several big pharma companies losing out recent court cases around intellectual property.
Click here to watch the full interview on the BBC website.
The decision today by India’s Supreme Court to deny Novartis a patent for its cancer drug Glivec® (imatinib mesylate) has been welcomed by Indian patient activists and generics manufacturers. However, it causes concern for the Swiss pharma company, along with Pfizer, Bayer and Roche, who are currently challenging patent decisions in India for their drugs Sutent, Nexavar and Pegasys respectively. The implications for pharma investment in R&D in India will also be worrying for the growing India CRO sector.
The Supreme Court ruled that the patent application was an example of “evergreening” – making a small alteration to an existing drug in order to gain additional patent protection. The compound is based on a drug originally patented in 1993, and its patent in the USA was granted an extension to expire in 2015. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited, stated that “Novartis has never been granted an original patent for Glivec in India” and that the company “provides Glivec free of charge to 95% of patients prescribed the drug in India, currently more than 16,000 patients”.
The ruling also raises questions around global pharma’s willingness to invest in India, which has a massive population although many of them cannot afford conventional drug prices. Issues around protection of Intellectual Property have dogged India for many years, with pharma patenting only being introduced in 2005. Novartis has previously said it needs legal certainty if it is to plan further investment in drug research in India, and other companies will doubtless be considering this when distributing their global R&D investment.