Securing solid representation in the pharmaceutical decision-making process is one of the major amendments pharmaceutical manufacturers seek to achieve if the pharmaceuticals draft law is approved.
“We expect that a pharmacist, representing the manufacturing sector will be appointed as a member in the higher committee which will be in charge of all drug-related issues in the new law,” said Hanan Sboul, assistant secretary general of the Jordanian Association of Manufacturers of Pharmaceutical Manufacturers and Medical Appliances.
Since the 1973 drug and pharmacy law came into force, the manufacturing sector was denied a seat in the technical committee in charge of pharmaceuticals registration, pricing and all drug-associated decisions. However, for the last one-and-a-half years, the Health Ministry has appointed a manufacturer as a member. “Until a-year-and-a-half ago, we had no say in the pharmaceutical business, and although we had a representative, his appointment was up to the health minister,” explained Sboul.
But in light of the fierce global competition in the pharmaceutical industry, marked by Jordan's accession to the World Trade Organization, and recent Jordan-US Free Trade Agreement, having a manufacturer's voice in the decision is driven by need, not luxury. “When the law was issued in the 1970s the industry had no worries about competitors. But now there is no subsidy, and thus we should participate in order to protect the local business, “ Sboul told the Jordan Times.
The higher committee, stipulates the draft, will be entrusted with setting rules, regulations and procedures governing the industry in terms of registration, pricing, rational drug use, and the availability of drugs. Several subcommittees will be responsible for implementing these guidelines. “This amendment is essential, as it falls in the interest of the national industry. It will also create a balanced formula as importers have always had a representative,” added Sboul.
The new law, expected to be in place by early 2001, will also tackle the pricing system. The current law does not define a time frame for setting a price for a drug by the Health Ministry. However, elaborated Sboul, the draft under study at the legislation bureau, states that a decision concerning the price will be decided in a limited time.
Drafted by the association, the Health Ministry, the Royal Medical Services, the Pharmaceutical Association, Owners of Drug Stores, the law will include the recent amendment made to the current law under which each product will undergo a re-registration every five years.
The regulations of the automatic registration, although approved since December1999, have not been implemented as the regulations are still being prepared. Including the recent amendment in the new law will be a safety valve, revealing any developments affecting the product in its country of origin. — ( Jordan Times )
By Rana Awwad
© 2000 Mena Report (www.menareport.com)