“A Just Cause: Quality Affordable Medicines for All”
16 August 2006
Senate of the
Mr. President, I rise to sponsor Committee Report No. 79 containing Senate Bill No. 2263.
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.
priced at P44.75 in the
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
400, priced at P17.75 per tablet in the
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.
kahit sinong bata na hinika sa
priced at P406 in the
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.
have been numerous efforts to address this problem. I recall that Senators
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.
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.
pharmaceutical industry in the
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.
proposed amendment is known internationally as the Bolar amendments after such
were entered into US Law. Many other countries have adopted similar provisions,
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
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
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.
international exhaustion principle leading to parallel importation is done by
numerous countries including
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?
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
We have a solemn duty to correct this injustice.
Mr. President, I ask this chamber for the swift passage of this measure. Thank you.