A Just Cause: Quality Affordable Medicines for All

Posted on August 16, 2006. Filed under: Resources |

by Sen. Mar Roxas

In every nook and corner of our archipelago, Mr. President, we have sick citizens who are sick not because there is no cure for their ailment, not because they haven’t been able to see a doctor for diagnosis, they are sick because they cannot afford the medicine that has been prescribed for them and which will make them well.

Ginoong Pangulo, kung si Juan dela Cruz ay tumaas ang presyon ng dugo at kinailangan niyang bumili ng gamot na Norvasc, mabibili niya ito sa Mercury sa halagang P44.75.

Pero ang taga-India, na katulad ni Juan na may mataas na presyon, ay makakabili ng Norvasc, na walang pinagkaiba sa binebenta sa botika, sa halagang P5.00 lamang.

Norvasc, priced at P44.75 in the Philippines, sells for the equivalent of P5.00 in India.

Kung ang Misis ni Juan dela Cruz ay may impeksyon, tulad ng respiratory tract infection, upang gumaling, kailangan niyang bumili ng Bactrim 400 sa pharmacia sa presyong P17.75 per tablet. Samantala, ayon sa Philippine International Trade Corporation (PITC), isang ahensya ng gobyerno, ang bawat tableta ng Bactrim 400 ay nabibili sa Pakistan sa halagang piso, at sa India, sa halagang 69 centavos.

Bactrim 400, priced at P17.75 per tablet in the Philippines, sells for the equivalent of P1 in Pakistan, and P0.69 in India.

Kung ang anak naman ni Juan dela Cruz ay may hika at kailangan ng Ventolin inhaler para lumuwag ang paghinga, mabibili ito ng kanyang magulang sa Mercury Drug Store ng P406 per inhaler.

Samantala, kahit sinong bata na hinika sa Bangkok, ay maaaring maibili ng kanyang magulang ng Ventolin Inhaler sa halagang P231 lamang.

Ventolin, priced at P406 in the Philippines, sells for the equivalent of P231 in Thailand.

Mr. President, what is so special about Thailand, India, Pakistan and other countries across and beyond our region, that these affordable medicines are available to their citizens while we Filipinos have to pay many more times for the same medicines?

Mr. President, I wish government can simply decree lower prices and have it come about. Unfortunately, this is easier said than done. There is no magic cure, no magic wand, to wave or wish this problem away.

There have been numerous efforts to address this problem. I recall that Senators Pimentel and Angara, co-authored the Generics Drugs Act, while Senator Enrile voted for its passage in 1988. Senator Juan Flavier championed it before and while he was Health Secretary, and up to the present.

Part of the rationale for enacting the Retail Trade Liberalization Law was to open the door to greater competition among drug stores and pharmacies.

The idea underlying these efforts was to create a more competitive and creative environment, such that our people will have viable and affordable alternatives for accessing their medicines.

These prior efforts to address this problem have made much progress but sadly because of poor implementation, or inhospitable circumstances, or worse, venal collusion, there has not been enough success to make substantial headway against the problem.

Today, we make another attempt to address this problem and thus give life to the public health provisions of our Constitution, and assure our people that their welfare is uppermost in our minds.

Mr. President, I have been studying this problem for quite some time. I was first sensitized to it during the illness and death from liver cancer of my brother at 32.

During his illness, I came across so many of our kababayans in the hallways and waiting rooms of hospitals who need not have been there at all, had they better access to lower priced medicines. I remember, while visiting him in the hospital, walking through its corridors and seeing so many patients trying to cope with their illnesses and their families worried sick for them.

Doon po sa ospital may nakausap akong matandang babae. Tinanong ko siya kung ano ang kanyang karamdaman. Sinabi niya na nag-umpisa ang kanyang sakit sa simpleng trangkaso ngunit dahil wala siyang pambili ng gamot, ito ay lumala at napilitan siyang pumunta na sa ospital.

When someone you love dies, it’s not political or economic, it’s personal. But for the poorest of the poor – those who could have saved their loved one if they only had the money to do so – it goes beyond what is personal. It goes straight to the question of social justice.

Let me cite three major obstacles to our people’s access to affordable, quality medicines.

The first obstacle is the structure of the pharmaceutical industry.

The pharmaceutical industry in the Philippines sold around P85 Billion worth of products last year. Roughly translated, this means approximately P1,000 for every man, woman and child in the country.

But unlike other countries, the industry here is characterized by extreme concentration of market power, in short, controlled by a handful of players.

In technical terms, what we now have is what’s known as an uncontested market. Whatever these players charge, the market will bear, because of the relative absence of competition and alternatives.

Kung ang gamot ay tubig, ang pagdaloy nito ay nagmumula lamang sa iilang gripo at kontrolado din ng iilan lang ang hose.

Iisa ang manufacturer at contract manufacturer dito. Halos iisa lang ang major wholesale distributor, ang Zuellig Pharma. Pagkatapos, halos iisa rin lang ang malaking retailer dito, ang Mercury Drug. Kaya sa kakulangan ng kompetisyon, mananatiling mataas ang presyo ng gamot sa Pilipinas.

The second obstacle has to do with the behavioral orientation of our consumers, doctors, and public institutions.

There must be continuing education on the Generics Law. Our consumers have yet to fully appreciate the value for money offered by generic substitutes. Our doctors and public health institutions must not negate the spirit of this law by failing to live up to their duty to inform their patients, particularly the poor, about generic substitutes.

The third and perhaps, biggest obstacle to affordable, quality medicines, is rooted in the protectionist provisions of existing law.

Certain provisions of the Intellectual Property Code (IPC) have been misused over time such that profit trumps public interest.

This is a case of unintended consequences where efforts to attain the goal of protecting inventions and creations have over time overwhelmed other efforts for the equally valuable goals of fairness, competition and consumer rights.

Because of the highly technical and abstruse nature of the intellectual property system, the multinational pharmaceutical companies have dominated the application of the intellectual property law to the detriment of public welfare.

It is in this context that your Senate Committees on Trade & Commerce, and, Health & Demography, have worked long and hard to arrive at Committee Report No. 79 containing Senate Bill No. 2263.

The principles that guided your committees in crafting this bill are:

1. To promote greater competitiveness and responsiveness in the Philippine pharmaceutical industry with the least government intervention. We need to loosen the monopolistic or oligopolistic power that some multinational pharmaceutical companies have long enjoyed to the detriment of all Filipinos by broadening consumer access to the supply of medicines and by supporting the domestic generics industry.

2. To adopt internationally accepted best practices that have made medicines more affordable and accessible in so many other countries around the world. In fact, all these proposed amendments are similar, if not exactly the same, as express provisions already adopted by other countries in their own patent laws. If others have it, then there is no reason why we should not provide the same for the benefit of all Filipinos.

3. To comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the DOHA Declaration on the TRIPS Agreement and Public Health of the World Trade Organization (WTO). And,

4. To increase the flexibility of government to anticipate and respond to various possible challenges to Philippine public health from global pandemics like bird flu or SARS and even to biological and/or chemical terror attacks.

In what manner does this bill accomplish what it sets out to do?

The salient features of Committee Report No. 79 containing SB No. 2263 are as follows:

First, we shall amend Section 72.3 of the IPC in order to expressly adopt the “early working” doctrine. This refers to the process by which generic companies are allowed to experiment and test for regulatory approval of generic versions of a drug or medicine before its patent expires. This will allow generic producers to get ready earlier so that they can start the production and sale of a generic drug shortly after its patent expires.

As explained by the WHO, in the absence of such provision, generic manufacturers can only start the time-consuming process of testing and registration after the expiry of the patent. This easily delays the marketing of generic drugs for another two to three years after patent expiry.

Once enacted, this proposed amendment will increase the supply of medicines by allowing the early or immediate entry of generic versions within a short period after patent expiration.

This proposed amendment is known internationally as the Bolar amendments after such were entered into US Law. Many other countries have adopted similar provisions, such as, Canada, Argentina, Thailand, Malaysia and Indonesia. Moreover, this principle has been recognized by the WTO in a case involving Canada vs. the European Union member states.

Second, we shall amend Section 72.1 of the IPC by adopting “the doctrine of international exhaustion of intellectual property rights” from the present domestic exhaustion principle currently applied in the Philippines.

Under the international exhaustion regime, once a product has been introduced anywhere in the world by the patent owner, then anyone may buy and import the same for resale in the Philippines without risk of patent infringement. This means that the price in the Philippines will be influenced by the price it is sold in other countries.

Consequently, this amendment will allow the parallel importation of medicines so that anyone, whether a trader or an individual, can shop beyond our shores for better prices. Thus domestic prices can be moderated through competition from imports of exactly the same medicines.

This international exhaustion principle leading to parallel importation is done by numerous countries including Japan, Israel and Thailand and others.

Third, in order to more easily operationalize the foregoing, CR No. 79 and SB No. 2263 seeks to amend Section 147 of the IPC such that there will be an exception to the application of trademarks and tradename restrictions when applied to parallel imports.

Fourth, the bill amends Section 22.1 of the IPC by disallowing the issuance of another patent for new uses of an existing substance that has already been patented.

This amendment limits the protection provided to the original patent of 20 years. This enables generic companies to aggressively market their own versions without threats of law suits arising from newly-discovered uses for previously patented products. The committee adopted this approach from the Indian Patent Act.

Fifth, the bill amends Section 74 of the IPC, “Use of Invention by Government”, in order to remove the requirement for government to undergo the long and tedious compulsory licensing process so that government may avail of the medicine for public health reasons in a more timely manner.

At present, the IPC requires the government to go through the cumbersome compulsory licensing procedures before it may use any patent. A review of Supreme Court cases on compulsory licensing would show that it takes 6 to 8 years before an entity has a clear approval to do the same. The health of our people cannot be made to wait this long especially in times of emergencies. The government must have the power to do this outright without need for a lengthy process.

Based on the standards set in the Senate Bill No. 2263 which is patterned after TRIPS, our government will have the ability to act decisively and immediately when confronted with debilitating illnesses like tuberculosis or public health emergencies like avian influenza and SARS – without fears of possible lawsuits from patent owners.

Mr. President, the official and public response to these proposed amendments has been overwhelmingly positive.

Support has streamed in from various sectors and quarters, including the following: 1) Department of Health (DOH), (2) Department of Trade and Industry (DTI), (3) Intellectual Property Office (IPO), (4) Bureau of Food and Drugs (BFAD), (5) Philippine International Trading Corporation (PITC), (6) National Institutes of Health (NIH), (7) World Health Organization (WHO), (8) Philippine Medical Association (PMA), (9) Drugstores Association of the Philippines (DSAP), (10) Philippine Chamber of the Pharmaceutical Industry (PCPI), (11) Third World Network (TWN), (12) Cut the Cost, Cut the Pain Network (3CPNet), (13) OXFAM Philippines, (14) Ayos na Gamot sa Abot-Kayang Presyo (AGAP), and, various NGOs for the poor and elderly.

Makatarungan ba na ang Pilipino ay magbabayad ng P9.61 para sa isang tableta ng Buscopan para sa sakit ng tiyan habang sabi ng PITC na ito ay 60 centavos lamang sa ibang bansa?

At makatarungan ba na ang Pilipino ay nagbabayad ng P17.98 para sa isang tableta ng Voltaren tuwing inaatake ng rayuma samantalang sabi nig PITC na 92 centavos lamang ito sa India?

We have a solemn duty to correct this injustice.

————————————————-
This is the Sponsorship Speech of Senator Mar Roxas on the Committee Report No. 79 containing Senate Bill No. 2263.delivered at the Senate of the Philippines on August 16, 2006.

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One Response to “A Just Cause: Quality Affordable Medicines for All”

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To be able to compare the prices from two or more countries, one must consider the following factors: 1. capability of the country to manufacture active ingredients, excipients and other raw materials needed for making a drug product; 2. government support on importation of active ingredients and raw materials; 3. minumum salary and cost of living in the country 4. government support for researches on natural products as source of excipients for making drug products; and other factors which I , in my knowledge , do not recognize at this moment.

I think extensive data should be further gathered and evaluated before making the same conclusion. Drug manufacturers are also affected with government imposed taxes. Do they have 12% E-vat in India or Pakistan? Do Indians have support from their government to maufacture their own active ingredients.

Opening the trade to other countries will only make the situation worse for rising drug companies. Why not support them? Sen. Roxas and other senators can also do the following: 1. lift some taxes for importation of active ingredients, excipients and machines for making these medicines. 2. support research on making USP or BP pure drugs and excipients in the philippines so we do not have to import. (we can now make drugs at lower price). 3. lift e-vat for medicines for they are essential t ones survival and not a necessity.
4. regulate promotional budget of multinationals so that the prices can be lowered and patients will not have to shoulder the cost of ads. , and others which I will think of in my entire lifetime.

I commend him for the intellectual property rights revisions. I think the PITC should do a little more research on the real problem on price discrepancy.

It will boil down to government support. I tell you.


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