Pharmacists step up protests against FDA’s drugs bill

UntitledBANGKOK POST Issued date 13 October 2014
Paritta Wangkiat
SPECIAL REPORT: Chemists fear it will be rushed despite consumer health concerns, writes
Pharmacists at various hospitals nationwide last week began protesting against a new version of the drugs bill approved by the Council of State (CoS), causing a headache for the Food and Drug Administration (FDA), which is overseeing the bill’s amendment.
Pharmacists are concerned about the bill’s second clause, which says that medicine can be dispensed by all healthcare professionals, from doctors, nurses, dentists and veterinarians, to physical therapists and Thai traditional medicine doctors and practitioners.
The bill, drawn up to replace the 1967 Drug Act, was forwarded to the CoS in 2006, following seven years of attempts by the Public Health Ministry to expedite its amendment.
The pharmacists’ protests have gone viral on social media with photographs of pharmacists from different hospitals raising their arms to make a cross, a symbol of opposition to the bill.
Their largest gathering last Thursday at FDA headquarters in Nonthaburi was a success, as it allowed protesters to apply pressure to the FDA to appeal to the CoS – which had returned the amended bill to the FDA on Sept 24, asking for confirmation within 14 days – to extend the FDA’s amendment period to 30 days.
The FDA promised to allow pharmacists’ representatives and academics to join the amendment process during this extension period.
FDA secretary-general Boonchai Somboonsook said he was willing to discuss amendments with all those concerned.
Led by Pharmacy Council of Thailand president Kitti Pitaknitinan, the pharmacists fear the bill will be rushed to the National Legislative Assembly (NLA), despite their claims there are seven points which pose a risk to consumer health.
First, Section 4 of the bill categorises drugs into three types – prescription-only medicines dispensed by doctors, dentists, veterinarians, Thai traditional and Thai modified doctors; non-prescription medicines dispensed by health professionals such as doctors, nurses, dentists, pharmacists veterinarians, physiotherapists, Thai-traditional and Thai-modified practitioner; and household medicines.
Pharmacists protesting against the bill voiced concern the proposal to allow certain types of drugs to be dispensed without pharmacists would be harmful to consumers because other health professionals may lack adequate medical knowledge.
Second, Section 24 of the bill allows health professionals other than pharmacists, doctors, nurses, dentists and physiotherapists, to mix different types of registered medicines and arrange pharmaceutical packages that combine sets of medicine, without the relevant medical authority.
Protesters agree that doctors can mix medicines for emergency cases, but the bill should not allow other health professionals to do similar things, which could endanger patients, they said.
Third, Section 25 of the bill allows practitioners of traditional medicine to produce, sell and import traditional Thai or alternative medicines without pharmacists’ control.
Protesters believe this will create a gap in the market for drug stores pursuing commercial interests without consumer safety in mind.
Fourth, Sections 47 and 51 of the bill exempt some drugs from registration, such as medicines mixed by health professionals.
The bill does not force the products’ owners and authorities to review the medicinal ingredients when requesting authority to extend the validity period of each medicine.
Protesters believe this will affect the medicine’s quality and offer the opportunity to mix harmful substances into medicines.
Fifth, Section 140 forbids advertisement of medicines that are banned, fake, claim false effects, are of declined quality, or are non-registered products.
However, it does not clearly state whether the ban on advertisements of dangerous drugs is included.
Protesters fear that an unethical private company could use this gap in the market to advertise a harmful drug.
Sixth, the bill does not make illegal the production and sale of drug sets: illegal polymedicines that are gaining popularity in Thailand, especially in rural areas.
Finally, the bill does not contain any administrative penalty for violators of the law.
Many pharmacists also claimed they had not been invited to take part in the drafting of the bill.
The FDA remained silent until last week when the pharmacists staged their protest urging Dr Boonchai to speak in front of them for the first time since the creation of the NLA.
Dr Boonchai claimed he could not comment on the bill while it was pending the CoS’ consideration.
The FDA would not forward the bill to the NLA if pharmacists and the FDA could not come to an agreement during the amendment’s extension period, he said.
Dr Boonchai admitted he would be unhappy if the bill was dismissed, as he claimed it would bring many benefits, although he did not elaborate on what they were.
The critics disagree. “[The FDA] should listen to different opinions before the implementation of the bill, or it will create conflict between health professionals,” Mr Kitti said. “Creating opportunities for others [aside from pharmacists] to dispense medicine will make it difficult for the FDA to regulate [illegal activities], which creates risks,” he added.
“Pharmacists claim the proposed bill has seven points which pose risks to consumer health.”

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