During the last five years, the number of commercial clinical pharmaceutical trials in Sweden has gone down. At the same time, it is apparent how emerging economies like China and India are striving to increase the number of clinical trials being conducted in their respective country. This report gives an insight into the countries’ efforts to develop the regulations for clinical trials and some of the challenges that involves.
China stands out as one of only a few countries in the world where the number of clinical trials has increased over the last five years, albeit from relatively low levels. India, on the other hand, is experiencing a downward trend despite its efforts. The incentives for the pharmaceutical industry to conduct trials in these countries include access to large markets, lower costs for the trials, access to large groups of patients with substantial genetic variation and, in some cases, little or no treatment history. However, it is not self-evident that increases in these countries will lead to fewer trials in Sweden. The increases can be linked in part to the globalisation of the pharmaceutical industry and to the fact that a growing number of companies are conducting more international multicentre trials. At the same time, it is important to understand and consider the trends in these countries when shaping efforts to promote clinical trials in Sweden.
Both countries are facing the challenge of creating a stable and predictable regulatory environment and developing government agencies that are able to uphold quality in the application process, implementation and scrutiny of the trials. Above all, the long licensing process is pointed out as being a bottleneck in these countries. China is breaching international regulations in this field concerning a clear allocation of responsibility. This is seen as being a major contributing factor to the shortening of application times even though the number of applications has increased by 20 % from 2012 to 2014. Even though phase I studies of pharmaceuticals developed outside China are not permitted, we can see a trend where Chinese government agencies have improved the prerequisites for international multicentre phase II trials. Data from this type of trial can be used for the introduction of new pharmaceuticals into the country. This development may strengthen the incentive for pharmaceutical companies to include China in their global development plans. In India too, there is legislation that prevents the phase I testing of potential pharmaceuticals that have been developed in other countries.
In India, several cases of anomalies concerning clinical trials were reported in 2010 which led to the government agencies in charge becoming more scrupulous in their work. This resulted in the application process becoming longer and the pharmaceutical companies perceiving the process as being less predictable. The number of conducted trials decreased by 25 % during 2011–2012, compared with 2009–2010. Another consequence of the reported anomalies in India was the introduction of a new set of regulations in 2013. However, the pharmaceutical industry perceived the new regulations as being unnecessarily stringent and the number of trials continued to drop in both 2013 and 2014. During 2014, a new and more coherent legislative text has been formulated to regulate trials on pharmaceutical products. If the law is adopted, it could be a signal to the industry that India now has a more stable set of regulations, which is forecast to have a positive effect on the number of clinical trials in the country.
Irregularities occur in China too and there have been cases where the implementers of trials have manipulated results and documentation. Nevertheless, the Chinese authorities are aware of the problem. As of 2013, they have been collaborating with, among others, the United States Food and Drug Administration (FDA) with regard to educating government agency personnel, researchers and companies. According to FDA, the authorities in China are well on their way to establishing procedures that will counteract irregularities. At the same time, there is a difference between China and India. In India, but not in China, the confidence of the general public in clinical trials has had a great impact on the formulation and use of regulations. However, low confidence in and mistrust of researchers is the single largest obstacle for the recruitment of trial participants in China.
The fact that both China and India are striving to increase the number of clinical trials is a development that could potentially be a contributing factor to a reduction in the number of clinical trials conducted in Sweden. But the trend could also create opportunities for Sweden. China and India have access to huge populations but, to a large extent, they lack the competence to conduct clinical trials. In Sweden, the situation is the reverse. Here, we have the competence and experience to conduct high-quality clinical trials but we lack a large population. Thus, one way of increasing Sweden’s competitiveness would be to shape the Swedish system so as to gain maximum benefit from the developments in these two countries. By cooperating with pharmaceutical companies and government agencies in China and India, Sweden can become a natural partner in international multicentre tests. There may also be grounds to review the support given to Swedish pharmaceutical companies that want to conduct clinical trials in China and India in order to help them penetrate those markets.
Serial number: Direct response 2015:08
Reference number: 2015/105