New body for sale and use of drugs

Malaysia chronicle PETALING JAYA - The Health Ministry plans to set up a body under the new Pharmacy Bill 2012 to oversee, monitor and regulate the sale and use of drugs.

The yet-to-be-named body will be empowered to issue directives and guidelines on generic drugs, as well as drugs pricing structures and mechanisms.

Health Ministry Pharmaceutical Services Division senior director Datuk Eisah A. Rahman told theSun that the new body will consolidate the functions of the Pharmacy Board, the Drug Control Authority and the Medicines Advertisement Board.

“These boards have overlapping functions and in order to cut down bureaucracy, a competent authority will be formed to take over these functions,” she said.

However, she did not reveal further details as she said the bill is still in the drafting stage, and is expected to be tabled in Parliament by the end of the year.

The body is also one of the efforts by the ministry to promote the use and awareness of cheaper generic prescription medication in the light of rising costs of drugs and healthcare.

“Initiatives have also been taken to create awareness among prescribers (doctors), and to promote and encourage the use of generic names in the private sector in dispensing medication to patients,” said Eisah.

Among them was the “Know Your Medicine” campaign in 2007, which was aimed at educating the public on the difference between trade names and generic names of their medication.

“There is a plan to include a module on generics in this campaign in the future,” she added.

theSun had on May 28 front-paged a report that the ministry is moving towards encouraging the use of generic drugs, which are cheaper than brand-name, or innovator drugs, through nationwide roadshows which will begin in August.

Generic medication are bio-equivalent versions of innovator drugs, and are the same in terms of dosage, quality, efficacy and performance, at up to 70% cheaper than the brand name drugs.

Generics are produced when patents on the innovator drugs has expired, and as such, will cost much less as they do not include the cost of research.

However, Eisah said there are no immediate plans to introduce a specific law mandating the use of generics, like the Generics Act in the Philippines.

This Act, which the Philippines has implemented since 1998, promotes the production, dissemination, prescription and use of generic drugs, as competition from generic drugs was seen as a crucial way to making quality drugs affordable in the country.

Eisah said there are already policies in place to promote the use of generics by the government.

“Generic substitution is addressed in the National Medicines Policy and is practised in ministry facilities. The ministry procurement procedure also encourages the use of generics when the products are off patent. In addition, all ministry facilities prescribe medication based on its generic name,” she added.

Meanwhile, Malaysian Organisation of Pharmaceutical Industries (MOPI) president Leonard Ariff Shatar told theSun that legislation that enforce the use of generics will work against it.

“It gives the impression that doctors are forced to prescribe generics and patients are forced to use it. In the end, the doctors should have the discretion on what medicines they want to give,” he said.

Leonard added that market dynamics in the pharmaceuticals industry is changing rapidly.

“In the past five years or so, you find innovator drug makers – large multi-nationals like Pfizer, Sanofi or GlaxoSmithKline – going into generics as well. In the coming years, you would find reasonably strong crossovers where Pfizer might make generics of GSK products and vice-versa,” he said, adding that this would further boost the use of generics.