A string of opposing voices have been heard this past week over the Drug Bill which, if passed into law, will govern the manufacturing, selling, import, registration and advertisement of medicines by the private sector in Thailand.
Many of the stipulations are the right calls. Others have been overhyped. Some have even caused unnecessary confusion -- especially speculation that the bill will pave the way for convenience stores to hire non-pharmacist staff to sell drugs.
Nonetheless, the dissenting murmurs stand as a reminder to the Food and Drug Administration (FDA), which proposed the legislation, to debate and resolve these contentious points widely prior to tabling the bill to the cabinet for their vetting and approval.
The bill, in its current form, features several controversial points and provides weak oversight concerning pharmaceutical advertising and registration, while lacking other needed regulations.
The FDA's intention to have it passed into law first and then amend the contentious points later, as outlined by secretary-general Wanchai Sattayawuthipong, is a reckless and costly move.
This legislation will have wide-ranging implications. First of all, it will completely repeal and replace the 1967 Drug Act.
This means it will set the procedures and regulations governing quality control of medicine imported, produced for or dispensed to those living in Thailand.
It will also govern Thailand's 140-billion baht pharmaceutical industry -- the second-largest such market in Southeast Asia.
While public debate has been heated, the media has mainly focused on misleading issues. These include concerns that the bill will let pharmacies allow unlicensed persons to sell medicine during the absence of pharmacists or that it will allow convenience stores to sell drugs.
In fact, the FDA-proposed bill states clearly that each drug store must be attended by a licensed pharmacist at all times. But the problem lies with its Section 33, which says in case of a temporary absence of a registered pharmacist the store owner can assign any person with "the same qualifications" to cover. But it should have explicitly stated that person is a licensed pharmacist to avoid exploitation.
The devil is also in the detail of other parts of the bill which allows licensed business owners, who are not required to be pharmacists, to have a greater role in providing oversight in the production or importation of drugs, even though the processes will still be handled by pharmacists.
Pharmaceutical experts also worry that the bill lacks a regulation to ensure the international standard of Good Manufacturing Practice will be adopted by drug manufacturers.
The bill has also been criticised for its loose regulation of advertising and registration of drugs for the sake of facilitating smooth processes for businesses.
Experts, especially those from the Pharmacy Council of Thailand, have questioned why the FDA's bill fails to address many contentious points raised during the public consultation process.
They also wondered why the FDA chose to propose this version of the bill to the cabinet, instead of using another better version which was earlier agreed upon by them and the public and approved by the Council of State.
The FDA is right in saying that its Bill features good points, such as the need for drug registration to be reviewed every seven years.
But there is still much more explanation that needs to be given by the FDA. The agency should allow more time for other stakeholders to give their input so that it can come up with better legislation. More consultation will also allow members of the public to be properly informed about legislation which is technical and highly complex in its content.
Those who are critical of the FDA all agreed that this new bill is important because the existing Drug Act has become outdated. But the FDA must tread carefully in the legislative process. There is no need to rush it.
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