• 
• 

Citing the high cost of research and development (R&D) for new medicines, multinational pharmaceutical companies, grouped under Prema, have been upset by the previous government's CL policy, claiming it violates their intellectual property rights.

So far, the CL policy has covered a number of new heart and cancer drugs whose patents are still valid. Proponents of CL have argued that their exorbitant prices have made the drugs inaccessible to low-income people.

As a result, the previous government resorted to CL to make the drugs much cheaper. Orders were placed with companies in India, for example, which are capable of producing a bio-equivalent version of the patented drugs.

However, Prema's international members, mainly US and European drug companies, have opposed the bid on the ground that they had invested substantially in new medicines and their patents need to be protected.

Prema CEO Kitima Yuthavong said each of the new drugs costs an estimated US$1 billion (Bt33.4 billion) in terms of R&D, so patents need to be protected to promote innovations in the pharmaceutical industry.

The R&D process is typically divided into five major phases.

The first phase is called drug discovery as researchers will have to identify a specific target that is a promising focal point for a new drug out of thousands of chemical compounds. Hundreds of potential drugs emerge from this process, but most will never be approved for patients.

The second phase is called pre-clinical testing as potential drugs are tested in laboratories and animals to see if they are effective and safe.

The third phase involves clinical trials in which the drugs are tested in people for effectiveness and safety. Up to 5,000 volunteer patients are involved in this stage of R&D. The time required to complete these clinical trials was on average 8.6 years during the 1990s.

Fourth comes the application process for a new drug with government authorities such as Food and Drug Administration of the US if clinical trials show the new medicines are both safe and effective.

Fifth is large-scale manufacturing and safety monitoring as inventor companies continue to gather information and finance research to review how the new drug is working.

Government authorities may also require drug companies to do additional clinical research to monitor long-term safety of new medicines or how a medicine affects a particular group of patients.

Patent holders have found CL an unacceptable policy. Their representatives hope the issue will be sorted out soon via dialogue among all the stakeholders concerned.

One solution is to develop a new healthcare financial model to suit conditions in Thailand. It could be a joint public/private sector programme involving both welfare and insurance components.

For example, the government may consider introducing a co-payment system in which the state pays 70 or 80 per cent of medical bills while individuals pay the remainder.

Or there could be a joint health insurance scheme in which the government and individuals co-pay the premiums for health coverage.