Philippines Trying to Cut Medicine Cost Associated PressPhilippinesJune 14, 2006 Stroke survivor Edmund Lising is supposed to take

four tablets of two medicines each day, including the antihypertension drug Norvasc. But to save money, the 58year-old retiree takes only two a day, supplementing the dose each time with a fervent prayer. Lising is luckier than most Filipinos. According to government statistics, 70 percent of the 85 million Filipinos have no regular access to lifesaving drugs. Next to affluent Japan, the cash-strapped Philippines has Asia's second most costly medicines, with some drugs priced 5 to 45 times higher than the same medicines sold in India or Pakistan, the data shows. Fed up with the situation, officials, consumer groups, health workers and fair trade advocates have teamed up in Effective Medicine at Affordable Prices, a coalition targeting multinational pharmaceutical companies with the aim of cutting the staggering cost of medicines in the country. The group is supporting legislation that would make importing cheaper drugs possible and encourage the production of generic drugs. The campaign's launch came as the Philippine government is battling the pharmaceutical giant Pfizer over plans to import cheaper Norvasc from Pakistan. In March, Pfizer sued two government agencies -- the Philippine International Trading Corp. and the Bureau of Food and Drugs Administration -- for alleged patent infringement. It asked a suburban Manila court to order BFAD to revoke an approved import registration for the antihypertension medicine covered by Pfizer's patent. The 17-year patent expires in June 2007. PITC head Roberto Pagdanganan said his office submitted last year to BFAD 80 sample tablets from Pakistan so that the government could be ready to import the cheaper medicine once Pfizer's patent expires. A 5-milligram tablet of Norvasc sells for 86 cents in the Philippines, nearly five times more than in Pakistan, where it costs 19 cents, Pagdanganan said. Another Pfizer brand, the painkiller Ponstan, is priced 14 times higher in the Philippines than in Pakistan. Pfizer's case has angered officials and consumers in the Philippines, where a third of the population lives in poverty and where hypertension is a major killer. Government data show multinational drug companies hold 70 percent of an estimated $1.9 billion Philippines pharmaceutical market. Rep. Ferjenel Biron, in a speech in the country's House of Representatives, recently called for a boycott of all Pfizer products. He accused the company of

''persecuting millions of Filipinos who simply could not afford to buy the said medicine and are left with no choice but just to die.'' Pfizer said its actions upheld the importance of encouraging innovation by protecting intellectual property of companies who discover and develop lifesaving drugs. ''This is simply a matter of protecting our patent for amlodipine besylate (Norvasc) through its expiration date of June 2007,'' Pfizer responded in a statement. ''We are seeking legal assurance that there will be no importation of an unauthorized amlodipine besylate product for the duration of this patent term.'' Pagdanganan called the Pfizer suit ''a harassment case,'' and filed a countersuit. ''It's greed and arrogance,'' he said. He said it takes more than a year to get BFAD's import approval, and by suing, Pfizer was effectively extending its patent. Every year's delay in the entry of the drug from Pakistan translates into $23 million in Pfizer sales of Norvasc, he said. Pagdanganan said PITC had not sold a single amlodipine besylate product in the Philippines and has promised not to do so until Pfizer's patent expires. The only issue, he said, is whether importing samples of patented drugs for registration purposes constitutes patent rights infringement. The practice is allowed under the ''Bolar Provision'' of the World Trade Organization's trade-related aspects of intellectual property rights, known as TRIPS. But the provision is not spelled out in the Philippines' Intellectual Property Code. TRIPS also allows countries to do ''parallel importation'' of a medicine, sold at a cheaper price in another country, even without the approval of the patent holder. Philippine officials blamed the country's high drug prices on a pharmaceutical marketing and distribution cartel, the myth that cheaper generic drugs are less effective, a patent system skewed in favor of multinational companies and heavy dependence on imported raw materials. ''The system has been so co-opted, if not corrupted, by some of these companies that the people are not left with so much choice,'' said Pagdanganan, whose office aims to cut in half by 2010 prices of medicines commonly bought by the poor. Sangeeta Shashikant, a researcher for the Third World Network, a Malaysia-based non-governmental organization, said big pharmaceutical companies often have a monopoly of patents and often, there is not much innovation to add to the cost, because drug companies are able to obtain new patents for only slightly modified versions of a drug -- a practice known

as ''evergreening.'' A World Health Organization report issued in April said in developing countries with inadequate technological capability, the fact that a patent can be obtained may contribute nothing or little to innovation. ''Patents may contribute to increasing the prices of medicines needed by poor people in those countries,'' the report added. Jim Nibungco, a stroke survivor and officer of the Stroke Survivors Support Foundation, said he has seen so many stroke survivors unable to buy needed medicines. ''Once they see the price of the medicines, they just close their eyes because they could not afford to buy them,'' he said. The coalition for cheaper medicine supports a bill that would amend local patent laws to keep them in sync with WTO rules, including clearly allowing parallel importation of drugs. The bill has been endorsed by a joint Senate committee for plenary approval. A staffer of the main proponent, Senator Mar Roxas, said the bill has been supported by majority of the senators, and it may be sponsored on the floor by July. The bill also seeks to shorten the period of patent protection, empower the local generics industry to experiment on drug formulas even before their patents expire, and deny new patent protection for slightly modified versions of a patented medicine. The PITC said government will put up more ''people's drug stores'' selling cheaper medicines to provide competition to big pharmaceuticals. Price controls for off-patent medicines, and a cap to spending on pharmaceutical advertising, also are being considered. Proponents of the bill said it has a good chance of being passed. A majority of the senators, including Senate President Franklin Drilon, have already signed the bill as co-sponsors. Nibungco, the stroke survivor, said he hopes that with the passage of the bill, hard-up Filipinos will no longer need to close their eyes, unable to buy needed drugs.

USD0.54 per tablet while it costs only USD0.07 in India. A Ventolin inhaler for asthma patients is sold for nearly USD8 in the local market while in India it costs only USD3. Other medicines also show the same disparity. Ponstan, a common painkiller, costs only USD0.08 in India but costs USD0.60 per pill in the Philippines. Bactrim 400, priced at USD0.40 per tablet in the Philippines, can be bought for only USD0.02 in Pakistan and USD0.01 in India. The Filipino lawmakers are bewildered why such differences in prices of the drugs as majority of the Filipinos can barely afford these drugs. Under tremendous pressure from various right groups, the Philippines Congress reportedly is considering a measure called the Cheaper Medicines Bill which aims to lower the cost of medicine by weakening or revoking patents on pharmaceutical drugs. The Bill seeks to amend the Intellectual Property Code in order to allow the parallel importation of more affordable medicines from abroad; support the generics industry by adopting the early working principle and to disallow the grant of new patents on grounds of new use and give ample muscle to the government through a framework for government use and compulsory licensing. The Bill also reiterates the president's power, patterned after the Price Act, to impose drug price ceilings in times of calamity, public health emergencies, illegal price manipulation and other instances of unreasonable drug price hikes. This Bill is expected to be passed by the Congress and it is expected to receive protests from pharmaceutical companies, particularly the innovator drug companies. The arguments that these innovator drug companies will have is that it costs them USD800 million on average to develop and introduce a new drug to market. Without the patent protection, it is unlikely that they can re-coup the investment and in fact will discourage further research and development in pharmaceutical drugs. Others feel that by simply enforcing the Bill will not lower the price of the drugs as the tax slapped on drugs are relatively high in the Phillippines. The Phillippines are currently charging an import tax of 5% and a valueadded tax of 12% on drugs. They feel that the best way of reducing the price is by lowering the taxes or scrapping all together will be a good start. Thailand The Thai government is set to continue to override the patents on three cancer drug treatments, Novartis' Femara, Sanofi-Aventis' Taxotere and Genentech's Tarceva. The government's compulsory licensing policy has been consistently reviewed and the latest report issued in March 2008 has revealed that by continuing the compulsory license policy, will save the government approximately USD100 million a year and allow cancer patients access to affordable drugs. Nevertheless, the Thai government also values its relationship with drug manufacturers who are willing to reduce the prices of the drugs. It was evident when Thailand cancelled its compulsory license on a fourth cancer drug, Novartis' Gleevec after Novartis agreed to supply it free to hundreds of leukemia patients in Thailand.

Copyright Global Action on Aging Wednesday, 28 May 2008 00:00

An Update On The Developments In The Philippines And Thai Pharmaceutical Patent Regimes
Philippines The cost of medicines in the Philippines is among the highest in the world. It was reported that Norvasc, a medicine for hypertension, is sold in the Philippines for USD1 per 5mg tablet; while in India and Pakistan, the same drug is priced at around USD0.14 whereas Plendil, also for hypertension, is priced in the Philippines at

A senior official of the government said the Government Pharmaceutical Organization would now start negotiations to obtain the three cancer treatments under compulsory license from generics manufacturers, including Indian firms which are currently supplying Thailand with HIV/AIDS drugs. However, he added that if talks with the innovator drug manufacturers resulted in significantly lowered prices, the government could decide to purchase these instead.

countries are able to produce the new drugs. The Brazilian government, facing a serious AIDS epidemic, was aware of this and decided to look for alternative sources of antiretrovirals. They were able to find suppliers that could provide the antiretrovirals at a cost of about 1,000 dollars a year. Not only that, a large Indian drug manufacturer, Cipla, announced last year that they could provide the drugs for 350 dollars a year. When Cipla, a very reputable drug manufacturer, says they can provide the antiretrovirals at 350 dollars a year, it means they are already making a profit on that cost, which makes you wonder how much is being made on the 7,000-dollar cost for the same drugs in the Philippines. Similar questions cropped up recently when the US government itself needed to order a patented drug, ciprofloxacin, for anthrax. When they asked Bayer to give a quote for producing 100 million tablets, the drug company said it would cost 1.77 dollars each. The American government asked around and found some drug manufacturers that could provide the drug at a lower cost. Eventually, with some haggling, Bayer brought down its cost to 95 cents each, with more discounts for future orders. (I discussed this in a column a few weeks ago.) Consumer groups were quick to capitalize on the US governments flip-flop with patents. If they were so ready to go around the patent system for its own citizens, why couldnt they respect the developing countries needs to lower the cost of medicines? What happens when people remain untreated for highly infectious diseases such as tuberculosis, which is the case for the Philippines? At the Doha meeting, several developing countries, backed by international nongovernment organizations such as Mdecins sans Frontires, Oxfam and Health Action International, lobbied for more flexibility with intellectual property rights. The result was the Doha declaration on the TRIPS agreement and public health. The document starts out by acknowledging "the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics." The ministers also acknowledge that intellectual property protection "is important for the development of new medicine" but recognize "its effects on prices." The document offers several alternatives to enable countries to respond to their public problems. One is the use of compulsory licensing. In this case, a government can declare a national emergency because of an epidemic and will require a drug company to license the government or other drug companies in the country to start producing a patented drug, at lower cost. Under compulsory licensing, the government still has to pay fees to the drug companies, but the drug ends up cheaper.

November 28, 2001

Public health and drug patents

By Michael L. Tan "WE agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health." That one line may yet provide the key to more affordable medicines in countries like the Philippines. It appears in a declaration issued at the conclusion of a World Trade Organization (WTO) ministerial conference held earlier this month in Doha, Qatar. TRIPS refers to the WTOs Agreement on TradeRelated Aspects of Intellectual Property Rights. To become a member of the WTO, a country must agree to respect these "intellectual property rights," which includes payment of royalties to inventors, writers, musicians. All that sounds reasonable; after all, someone should be compensated for innovation. Drug companies, in particular, have been the most vocal defenders of patents, arguing that they have to recover the investments they put in for research and development. Under the present system, when a drug company registers a new drug in a country that recognizes patents (that includes the Philippines), it will have exclusive rights to produce and sell that drug for 20 years. Unfortunately, because of this exclusivity, many companies end up dictating the prices of their medicines. There have been debates surrounding these intellectual property rights, mainly on what would be reasonable in terms of returns on investment and on profits. The United States government has tended to be quite dogmatic about these patents. Last year, it threatened several countries with sanctions because those countries were looking into alternatives for procuring medicines for HIV/AIDS. Most of the antiretrovirals (drugs that slow down the reproduction of HIV) are fairly new and are very expensive. Typically, the antiretrovirals would cost about 10,000 dollars a year in the United States, and about 350,000 pesos (7,000 dollars) in the Philippines. Not all countries recognize the same patent system that the United States and the Philippines have, which means drug companies in some

The Philippines has a law allowing this compulsory licensing for pharmaceuticals. Unfortunately, it was issued by the dictator Marcos and used to his advantage. He assigned exclusive rights for the production of the antibiotic ampicillin to a crony company. Because Marcos only shifted the monopoly away from multinationals to his own crony company, it did not result in cheaper ampicillin. In Estradas time, and now under Macapagal, the Department of Trade and Industry and the Department of Health have resorted to parallel imports. In this case, they import drugs from other countries subsidiaries of multinational companies. Its really a matter of "shopping around" for the same product but in different countries, and importing the drugs from cheaper sources. The government started this with a small selection of drugs and were themselves shocked to find the large differences in costs. The multinational drug companies werent too happy and sued the government. The Doha declaration now opens the way for the Philippine government to go full steam ahead. Right now, the government is using parallel imports only for six drugs, which are sold only in a few government hospitals. With Dohas declaration on public health, its time the government expanded the importations and made more medicines affordable for Filipinos.

there are already domestic laws in set, apart from the Conventions existing under the World Intellectual Property Organization. However, the extent of protection and enforcement of these rights still vary around the world. The TRIPS Agreement is seen as a way to introduce more order and predictability. The Agreement is important for developing countries like the Philippines because it establishes a multilateral rule of law in the area of intellectual property, therefore levelling the playing field in the world economy. In addition, it especially allows for balance and flexibility in its provisions, which developing countries can use to their advantage. The TRIPS Agreement is a "minimum rights agreement", providing simply a set of minimum standards of intellectual property protection for each category of rights, leaving the Members free to determine the appropriate method of implementing its provisions. The Philippines has chosen to exercise this right of flexibility in the area of patents in public health. In the Philippines, patented drugs produced by large multinationals are often inaccessible because of high pricing. Recognizing that the level of intellectual property protection afforded to patents on medicines is a factor for this pricing, law and policymakers, with the support of the Intellectual Property Office- Philippines, sought to take full advantage of the flexibilities allowed by the TRIPS Agreement. In 2008, Congress enacted R.A. 9502, "The Universally Accessible Cheaper and Quality Medicines Act", which contains amendments to the provisions of the old Patent Law (R.A. 8293, The Intellectual Property Code). The TRIPS Agreement allows Members to exclude from patentability inventions in order to protect human life or health. Thus, the Cheaper Medicines Act adds to the list of what are not patentable:

PATENTS FOR PUBLIC HEALTH IN THE PHILIPPINES Written by Jeifan - Ira C. Dizon The World Trade Organization (WTO) is the only global international organization dealing with the rules of trade between nations. Born in 1995, it is both a negotiating forum, working highly on consensus of the Members, and a forum for settling trade-related disputes. As of July 2008, there are 153 Member-countries. Central to the functions of WTO are the Agreements negotiated and signed by its Members, and which cover three broad areas: goods, services, and intellectual property.The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (The "TRIPS Agreement") is thus far the most comprehensive on the matter of intellectual property. Intellectual property rights, in general, are rights given to persons over the creation of their minds, with certain conditions. The areas covered by the TRIPS Agreement are copyright and related rights, trademarks (including service marks), geographical indication, industrial designs, patents, lay-out designs of integrated circuits, and undisclosed information, including trade secrets. Intellectual property protection is not new to most countries, as

" mere discovery of a new form of a new property of a known substance which does not result in the enhancement of the known efficacy of the substance " mere discovery of any new property or new use for a known substance " mere use of a known process unless such known process results in a new product that employs at least one new reactant

This prohibition is intended to curb "evergreening", which is a scheme employed to extend patent protection on a product, i.e., through applying for multiple patents on a products separate properties. When a patent expires, it is only then that other manufacturers can produce their generic versions of the drug, to be made available at a lower price.

The other amendment under the Act pertains to strengthening "compulsory licensing", which in the IP Code refers to a license granted by the IPO Director General to exploit a patented invention, even without the agreement of the patent owner, under certain conditions. In the WTO Doha Declaration on Public Health in November 2001, it was recognized that some Members with insufficient or no manufacturing capacities could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. Thus, the "Paragraph 6 System" was devised by the TRIPS General Council, whereby a Member may grant a compulsory license to export a drug or medicine to an eligible importing Member. This was an exception carved to the TRIPS rule that compulsory licenses shall be for a use authorized predominantly for the supply of the domestic market. Incorporating this Paragraph 6 System in Philippine IP law, the Cheaper Medicines Act provides for the grant of "special compulsory licenses" allowing the importation of patented drugs or medicines, provided adequate remuneration shall be paid to the patent owner and there are reasonable measures to prevent the re-exportation of the products imported. Only the Philippine Supreme Court can issue an injunction to prevent the grant of such compulsory license. This special compulsory license is intended to address the problem of local production capacity not being able to meet the demand of the market. Indeed, there is a need to balance the protection of intellectual property rights with the right of the public to health services at affordable cost. As enshrined under the Constitution, the State shall protect exclusive rights to intellectual property, particularly when beneficial to the people.

The Philippine patent, granted in June 1990 and expiring next month, is held by its British unit, Pfizer Ltd. UK. PITC argued that the patent for Norvasc was "neither new and novel nor non-inventive."

A Norvasc tablet costs about one dollar in the Philippines but only some 10 cents in India, PITC said on its website. PITC says multinational drug companies control around 70 percent of the Philippines' market. pharmaceutical

The worlds top drug maker has been embroiled in a series of litigations pertaining to Norvasc of late. Recently, a federal court in North Carolina upheld Pfizer's patent covering amlodipine besylate, prohibiting the US subsidiary of Synthon from launching a generic version of the drug until September 2007.

The patent covers the besylate salt of amlodipine, its pharmaceutical composition with a diluent or carrier, and its tablet formulation consisting of an anti-hypertensive, antiischemic or angina-alleviating effective amount of the API. Before that a federal court jury in Virginia ruled that Pfizer did not infringe on another patent owned by Synthon covering a process which Pfizer has been using for over 15 years for making amlodipine, and found that patent invalid on multiple grounds.

Synthon unsuccessfully argued that Pfizer's patent is invalid because of obviousness and the lack of adequate written description. The court ruling in North Carolina is subject to appeal.

Norvasc accounts for $4.71bn (3.66bn) of Pfizer's

Philipines wants Pfizers patent on blood pressure pill cancelled

May 17, 2007: Close on the heels of Brazil and Thailand, Philippines too is seeking to break the patent monopoly of a blockbuster drug so that they can avail the antihypertension medicine at affordable costs.

$51.3bn

2005

revenue.

Recently, Brazil decided to issue a compulsory license for the import or manufacture of generic versions of another US firm Mercks efavirenz. Brazil's health ministry plans to import a generic version of efavirenz from India, paying about 45 cents per pill, and may also start making its own copy of the drug after rejecting the New Jersey-based Merck& Cos offer to cut its $1.59 per pill price by 30 percent. Brazil wanted to pay what Merck charges Thailand--$0.65 per pill.

Philippine International Trading Corp. (PITC), a stateowned company, wants regulators to cancel the patent held by pharmaceutical giant Pfizer on one of its largest drug Norvasc.

Last year, Thailand had taken a similar decision. Other PITC urged the Intellectual Property Office to cancel the US-based company's exclusive patents on amlodipine besylate (the active substance in Norvasc) so that Filipino pharmaceutical firms can import or produce cheaper alternatives of the medicine. BY OUR PHARMA CORRESPONDENT countries, including Canada and Italy, have also used a clause in World Trade Organization rules to flout drug patents in the name of public health.