Leveraging clinical research exports
Clinical Research, also known as Clinical Investigation, is the business of testing new drugs or compounds in human subjects for discovering potential beneficial effects and determining safety and efficacy. This activity is now being increasingly outsourced by the multinational pharmaceutical industry. It was estimated to be a $6 billion market in 2002 and had reached around $10 billion by the end of 2005. The sector is now estimated to have reached a volume of $60 billion and the Asian and Eastern European Contract Research Organizations (CROs) are said to have played an important role in this regard.
Pakistan is the 6th most populous country in the world with a population of 180 million. According to WHO estimates, the country has nearly 10 million patients. By the end of 2009, the total number of registered doctors was 139,555, dentists 9,822 and registered nurses 69,313. According to available figures, the population–to-doctor ratio is 1183:1, which means there is one doctor for1, 183 persons. The population-to-dentist ratio is 16,914:1 and the patient per bed ratio is 1592:1. Healthcare units in the public sector are: hospitals - 968; dispensaries - 4813; basic health units - 5,345 and rural health centres - 572.
There are eight CROs currently working in Pakistan, of which six are in Karachi such as Metrics Research, which is also the country’s first CRO (established in 2003,), IRD, Clinision, Verum Venture, Medco Group, Universal labs, Medessense in Lahore and Milestone Biostudies Centre in Islamabad. Many of these CROs are involved in international clinical trials in therapeutic care such as oncology, hematology, osteoporosis, infectious diseases, cardiovascular diseases, ophthalmology and diabetes.
Clinision has 1100 healthcare professionals and Metrics has 400 such professionals, who are mainly doctors, university students and some international students, GSK, Eli Lilly, Pfizer and Sanofi Aventis have also trained a large number of personnel.
With a large number of English-speaking physicians, a large network of medical centres coupled with the low value of the Pak rupee, Pakistan should be an attractive venue for Contract Research. The role of the Trade Development Authority of Pakistan (TDAP) is crucial in this regard. As the TDAP’s mandate is to enhance export of goods and services from Pakistan, Clinical Research Services can offer a great potential in generating export revenue for the country.
Realizing this potential, the TDAP, in collaboration with the Ministry of Health and the Jinnah Postgraduate Medical Centre (JPMC), aims to invite companies that conduct clinical trials to come to Pakistan and establish their centres in the country. These three government organizations have already planned to attract more international outsourced clinical trials from overseas.
To further expand the activity area, there is a need to develop partnerships with international CROs and other outsourcing providers. Some of the major CROs in the world are interested in working in Pakistan but they need encouragement from the regulators in Pakistan. They are also concerned about data reliability and management, documentation and intellectual property rights. There should be a platform that can look at these issues holistically and also acts as coordination platform. TDAP intends to provide such a platform.
In a number of seminars organized in this regard, the TDAP Chief Executive, Tariq Puri, has focused on the understanding of Clinical Trial Management and what Pakistan can offer to the foreign CROs, identifying the gaps in the system and finding ways and means to make the environment more viable for foreign institutions to invest in clinical research in Pakistan.
TDAP is committed to recognizing and encouraging the need for developing clinical trial management in Pakistan, since CROs also offer opportunities to enhance the country’s healthcare facilities when they conduct clinical research and manage data as per international standards which would lead to quality training of healthcare providers and management of research in the country. Focus on this area is required to promote and create awareness about the opportunities in a $60 billion global market.
TDAP has assured the stakeholders that it will take every possible measure to provide support both to the government institutions and the pharmaceutical companies to jointly benefit and promote Pakistan’s potential in the field to leverage exports in the services sector