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In the past decade, the interest in running clinical trials in so-called emerging regions of the world has surged. Within Asia while China and India continue to draw in international sponsors, Pakistan remains a relatively unknown quantity for clinical trials. Attractions
Modern clinical trial programs necessitate a large number of patients. This has resulted in many companies expanding the number of locations for their clinical trials, particularly in populous emerging regions which can prove cost-effective. Another advantage of this approach is that local physicians gain experience of a pharmaceutical product through working on its clinical development and so are more familiar with it when it appears on the market. Therefore the globalization of clinical trials complements the entry into newer markets.
As the sixth most populated country in the world – with a population of nearly 170 million - Pakistan would appear to be highly attractive to pharmaceutical companies in their quest to involve more patients in their international clinical trials (1, 2). From a practical point of view, English is often used as a business language and this would be of benefit to sponsors seeking to operate in the country. Operational costs have been described as on a par with India and this would be an added attraction (3).
In terms of the healthcare infrastructure the picture is less clear, and it is not straightforward to identify suitable locations for clinical trials that can be run to international standards. However, many Pakistani healthcare personnel have trained abroad and maintain an active interest in the latest international medical developments. They may therefore be interested in serving as investigators for clinical trials and will be useful points of contacts for companies.
World Health Organization data reveal that Pakistan spends 2.4% of its GDP on healthcare, which ranks poorly alongside the 5.6% of GDP spent by China and 4.8% of GDP by India. The government’s general approach to the healthcare system has come in for frequent criticism (5, 6). While modern, highly equipped hospitals do exist so do poorly resourced ones, particularly in rural areas (4).
The Pakistani authorities state that the healthcare system is being reformed in order to develop health management specialists and to give greater autonomy to hospitals at a local level. Special emphasis will be placed on the treatment of HIV/AIDS, tuberculosis, malaria and hepatitis. Best practice will feature as a defined subject in professional training for healthcare personnel so that better use of resources can be encouraged. Whether such measures will satisfy the government’s critics and whether healthcare spending is increased remains to be seen.
Drug regulation in Pakistan currently takes place through the Drug Control Organization but regulatory changes are on the way. In 2006, draft legislation was put forward for the establishment of a body to be called the Drug Regulatory Authority of Pakistan. As part of its function, this body will oversee areas such as R&D, pharmacovigilance and drug information (7). The new authority will also liaise and interact with counterpart regulatory agencies and organizations in other countries for capacity building and exchange of information. Regulations concerning the conduct of clinical trials should appear as part of these new developments.
An interesting idea is the setting up of joint clinical trial centers with India, which was put forward at a 2006 conference entitled India-Pakistan Opportunities in Healthcare Sector (3). At present both countries are developing detailed proposals that will become the basis for further discussion. Factors that have been put forward to support the ambitious concept are similar operational costs and similar disease pattern prevalence between the two countries. However, there is no indication as to how a joint regulatory system governing such a system would operate. Not quite there yet
From an examination of other emerging regions of the world that have been transformed into preferred locations for clinical trials, it is clear that tough operational conditions do not deter ambitious drug development organizations. Instead, they use their local knowledge to build on the elements that are favourable in order to conduct the work they believe feasible. In time, if conditions improve, they can use this as a starting point for an expansion of operations. Many emerging regions have become highly competitive for the conduct of clinical trials, thus many companies are often interested in working in countries where their rivals have little presence. Given the current regional emphasis on India and China, Pakistan could represent a ‘less-crowded’ area for companies looking for newer markets in which to operate.
Yet while possessing a number of disparate factors that are beneficial for the conduct of clinical trials, the lack of unifying forces that can draw these together is limiting Pakistan’s ability to rival other emerging regions. Companies wish to see a clearly defined environment in which they can operate, even if they believe improvements are warranted in particular areas. For Pakistan, the clinical trial environment remains unclear and it can be difficult for companies to familiarize themselves with the basic requirements needed to operate there. Without strong government commitment to build a clinical trial network, Pakistan will continue to be overlooked.
Other emerging countries have faced similar obstacles and have overcome these through a dedicated and overt drive by governments to invest in healthcare infrastructure, provide research incentives for companies, establish suitable regulatory and ethics frameworks and introduce intellectual property standards that can compare with those elsewhere in the world. If Pakistan is interested in attracting more clinical trials to the country, then it must take bold steps in these areas, publicize them and inspire the confidence of international sponsors in the measures taken. The speed of current healthcare and regulatory reforms will be crucial in this respect. References
- Anon (2002). Population Association of Pakistan.
- Anon (2006). Pakistan. CIA World Factbook.
- Anon (2006). Pakistan has shown willingness to set up joint clinical trial centres with India. India Daily.
- Fazal A (2000). Planning your elective – Pakistan. student BMJ 2000;08:303-346.
- Gillani W (2003). PMA report roasts health policy, practice. Daily Times.
- Anon (2005). Healthcare targets remain elusive. DAWN.
- Drug Control Organization.
Dr Faiz Kermani has several years experience in both academia and the pharmaceutical industry. He has worked in pharmaceutical R&D, pricing and reimbursement, marketing and medical communications. He holds a PhD in Immunopharmacology from St. Thomas’ Hospital, London and a First Class Honours degree in Pharmacology with Toxicology from King’s College, London. He has written extensively on international healthcare issues, and is on the editorial board of a number of publications. In March 2006, he was a delegate on the UK Government’s Trade and Investment Biotech Scoping Mission to China and was a speaker at the subsequent presentation.
You can contact Dr Kermani via email@example.com