Ensuring Access to Cheap Medicines and the Pfizer Case

Posted by: Alecks P. Pabico on 12 May 2006 at 3:38 am

WHY is amlodipine besylate, the maintenance drug taken once a day by millions of Filipinos suffering from hypertension, more expensive in the Philippines than in other countries?

Manufactured by the world’s leading pharmaceutical giant Pfizer and sold under the brand name Norvasc, amlodipine besylate is locally purchased at P44.75 per 5-mg tablet and P74.75 per 10-mg tablet.

But in India, the medicine, marketed by Pfizer under a different brand name, Amlogard, can be bought at the equivalent price of only P7.77 (5 mg) and P11.67 (10 mg). In Indonesia, Norvasc is sold at the equivalent price of P21 (5 mg) and P37.93 (10 mg) while in Thailand, it costs about P26.65 (5 mg) and P45.65 (10 mg).

It is a sad fact of life that medicines in the Philippines are several times more expensive than in most countries. The Philippines is in fact second to Japan in having the highest medicine prices in Asia. Despite the passage of the Generic Drugs Act almost 20 years ago, prices of medicines have not significantly gone down and continue to deprive majority of Filipinos access to affordable and quality medicines.

The culprit, according to the multisectoral Fair Trade Alliance, is the monopoly that multinational drug companies like Pfizer have on the Philippine pharmaceutical market estimated at P80 to 100 billion.

Last year, Pfizer sold P1.2-billion worth of Norvasc, corresponding to a 34.5 percent growth.

“It’s a monopoly often sustained by the patent rights of these companies over these medicines,” said Angelito Mendoza, FTA labor convenor. Multinational companies, in fact, hold more than 90 percent — if not all — of patents granted by the Intellectual Property Office (IPO).

As a form of intellectual property, patents are awarded to inventions and improvements of a new product or process, granting to the inventor exclusive rights to the manufacture, use, or sale of that invention. Pharmaceutical patents are given for a limited period of usually up to 20 years.

The issue of an uneven playing field in the local pharmaceutical industry has recently been brought to fore with the patent infringement case filed by Pfizer against the Philippine International Trading Corp. (PITC), Bureau of Food and Drugs (BFAD) and two of its officals — Director Leticia Barbara Gutierrez and lawyer Emilio Polig Jr. — for importing samples of Norvasc. Pfizer holds Philipine Letters Patent No. 24348, the patent on amlodipine besylate.

In September 2005, the PITC brought in 40 pieces each of 5-mg and 10-mg Norvasc tablets from Pakistan and submitted these to BFAD for registration. BFAD, being the agency under the Department of Health which regulates the registration of medicines before they are marketed in the country, in turn granted PITC’s parallel import drug registration.

By virtue of Executive Order No. 442 issued by Gloria Macapagal-Arroyo in July 2005, the PITC was designated as “the lead coordinating agency to make quality medicines available, affordable and accessible to the greater masses of Filipinos.”

PITC’s mandate allows it to engage in parallel importation of low-priced generic medicines from countries like India and Pakistan.

The World Trade Organization’s (WTO) TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, which was further reinforced by the 2001 Doha Declaration on public health, also accorded governments and member-states various tools, including parallel importation and compulsory licensing, to fulfill their public health obligations and ensure access to cheaper drugs.

Parallel importation allows patented medicines to be purchased from the cheapest source without having to get the consent of the patent holder. Compulsory licensing allows governments to order a local firm to produce a drug and pay for a negotiated royalty to the patent holder.

But Pfizer is claiming that the case is not one of parallel importation because the product in question did not come from a source it authorized. It has therefore asked the Makati RTC to revoke PITC’s parallel import drug registration and to enjoin BFAD from entertaining applications by generic drug companies for registration of amlodipine besylate. Pfizer’s patent on amlodipine besylate is set to expire on June 13, 2007.

Industry sources say the court case will effectively extend the multinational company’s monopoly over amlodipine besylate by at least 18 months, which is the period it takes BFAD to evaluate an application for drug registration filed by a generic company.

Sec. Roberto Pagdanganan, president and chairman of PITC, said that they obtained the Certificate of Product Registration (CPR) for the anti-hypertension drug only in anticipation of the patent’s expiration.

“We have not marketed or sold a single Norvasc. In fact, we have informed Pfizer that we have no intention of doing so until after the Pfizer patent expires,” he said.

PITC has since filed a counter-suit against Pfizer.

FTA’s Mendoza is urging the government to invoke the “policy flexibilities” in the Doha Declaration, without which, he said, would only mean that “more Filipinos will suffer and die needlessly.”

The FTA, he said, is also seeking the passage of Senate Bill No. 2139 filed by Senator Mar Roxas to address specific provisions in the present Intellectual Property Code (Republic Act No. 8293) to enable a level playing field in the local pharmaceutical industry in order that generic equivalents of patented drugs can be easily brought into the market and provide lower-priced alternatives within reach of poor Filipinos.

In a recent forum, Roxas noted that more families are increasingly having a difficult time coping with health emergencies due to financial constraints and that indigent patients are accumulating debts in purchasing badly needed medicines for their life-threatening ailments.

The senator said he hopes his amendments to the IP Code will result in making affordable medicines with the same quality as branded ones available in the market.

“This is a bill worth fighting for because it is for the benefit of every Filipino who ahs a right to quality and affordable medicines as part of our public health service,” he said.

An industry source also pointed to the glaring absence of an explicit “early-working exception” or more commonly known as the “Bolar provision” in the IP Code. The said provision, he said, allows all development, testing and experimental work, including the importation of samples, required for the registration of a generic medicine to take place during the patent period of the original product. This is to ensure that generic medicines become immediately available in the market after the patent expires, improving access and competition.

Acknowledging the impact of the Pfizer case beyond amlodipine besylate, Pagdanganan warned that the issuance of a temporary restraining order to Pfizer would provide multinational companies the strategy for preventing the immediate entry of generic equivalents.

“Our goal is to provide the Filipino people with access to medicines at prices they can afford,” he said, in keeping with the government’s target of reducing the price of essential medicines by half of their 2001 levels by 2010.