National Institute for Health and Clinical Excellence (NICE) is a part of the UK NHS (National Health Service). NICE was established with the primary objective to set quality standards for medicines, track innovative technologies and weave them into the healthcare system of the country; and lastly, try and reduce variation in practice. Now NICE has gone a step further in setting its footprint overseas by advising governments, including Indian government, on the implementation of processes and methodologies.

In a freewheeling conversation with Nayantara Som of BioSpectrum in early 2010, at London, Dr Kalipso Chalkidou, Director, NICE International, throws light on the various initiatives taken by NICE, giving a bird's eye view of the organization.

Can you throw some light on NICE International? 

We set up an international division of NICE, about a year-and-a-half ago, in response to the interest expressed by foreign governments,  particularly in our model, methodology, processes and value judgment. This interest intensified, and the board of NICE, set up a small group who would just respond to these interests. This is a non-profit venture, but we do need to recoup our costs because NICE uses the budget fixed by the NHS, and we receive support from the International Department of Health, Department  for International Development. We have been working with the World Bank. For example, we were invited to review our Canadian equivalent. We have maintained good relations with AHRQ (Agent for Healthcare Research and Quality), US, about methods processes,  insurance companies, venture capitalists. The State of California in the USA, has adopted our guidelines.

Does NICE International have any initiatives in India ?

In India, NICE has been interacting with counterparts in the states of Kerala, Tamil Nadu, Andhra Pradesh and Delhi, especially for the National Rural Health Mission (NRHM). But NICE does not develop guidance for them. It is about giving advice on processes, methodologies and pilot critical questions, like we have done in Turkey and Columbia. The idea is to try and transfer things that are viable and useful, according to the dynamics and profile of that particular country. In India, the dynamics might be different, but the challenges are the same as with UK— issues around clinical standards and quality, are taken up in the same way. The government in the UK worries about issues like differential access to quality medicines, variation and equity, in the same way that India worries about different groups of the population gaining access to different treatments, depending on their affordability and educational background, issues around rational drug use. When both parties face the same or similar issues, it is easy to share the ways we tackle a given situation, however, an independent decision to use a particular solution has to be made. We emphasize that we do not want to transfer a system directly into another country. The government of India is investing public money on health and that brings issues of accountability – when it becomes important what mechanisms are used, the views and expertise of stakeholders into the system. This is the area where NICE can help.

Is NICE International involved in any overseas training courses for policymakers in particular?

We do conduct many training programs overseas, for policymakers, in strategy. We also work with medical associations, colleges and academic units. We provide consulting. We are also interested in implementation, rather than just report writing, and provide assistance in developing products. In India, we participate in postgraduate and undergraduate education reforms, by utilizing our networks and colleagues from the World Bank, to help reform the curriculum for medical students.

How does NICE ensure that the NHS gets good value for money for the medicines/technologies it procures from companies?

NICE has been working to ensure that NHS gets good value for money, and patient access schemes is one of the mechanisms. We have patient access schemes, also called the risk sharing schemes, which are arrangements, whereby  patients gets access to drugs which might not be good value for money, if certain conditions are not met. In such situations, some companies may accept returns, or will offer the first cycle for free. This fairly reduces the transaction price. In one case, the company offered to collect information on the effectiveness of the drug, and then reimburse the amount, if the drug fails to meet expectations. These decisions are made by practicing clinicians, scientists, industry and patient representatives, jointly, by considering factors apart from the costs.

So what does the future look like for NICE?

We are looking at imaging tests and devices, and this is an exciting development, as this area has no regulators, and there are no trials other than Quality Control. It is a challenge on how to tackle this issue. This was started last year, when we organized meetings to chalk out methodologies and processes, and then we referred to the dossier report – which looks at quality, good value innovation; and then, we looked at national level. There is a lot of potential in this sector.