Archive for the ‘Medicine’ Category

Wigberto E. Tañada, Lead Convenor

Magandang umaga sa ating lahat! A warm welcome to you all, especially to our foreign participants and delegates to this Regional Workshop on Access to Medicines!

This Regional Workshop comes at a most appropriate time. And we thank all the participants and delegates from the different Asian regions for coming together to share their respective experiences in the campaign and the battle for insuring and increasing people’s access to medicines. Indeed shared experiences, shared learning and a shared future are our best teacher and inspiration in this arduous fight against the goliaths of the global pharmaceutical industry.

The WTO’s Doha Declaration on TRIPS and Public Health provide member countries certain crucial flexibilities such as the right of countries to resort to parallel importation in order to lower drug prices, the right of governments to give compulsory licenses for drugs critical in the treatment of diseases affecting a large part of society and the right of governments to engage in the domestic production and timely distribution of drugs whose patents are about to expire. Despite its limitations, the WTO Doha Declaration on TRIPs explicitly upholds the rights of governments to enforce measures that will protect public health and insure access to affordable medicines for all especially the poor. Through parallel importation, patented medicines can be purchased from the cheapest source rather than from the patent holder manufacturer. Compulsory licensing on the other hand allows governments to order a local firm to produce a drug and pay a negotiated royalty to the patent holder.

Since this is a gathering of fighters for affordable medicines, I believe we are all familiar with these WTO TRIPs flexibilities. The problem really is how do we counter and overcome the transnational resistance to our exercise of these flexibilities. The bigger challenge is what can our societies do beyond these flexibilities in order to make medicines accessible and affordable for all. As it is, these WTO Doha TRIPs flexibilities are merely on paper and they will remain to be so unless governments are able to summon the will to implement and make use of such flexibilities in the face of the transnational resistance.

In this connection, we, in the Philippines, have experienced last year and this year the reach and power of this transnational resistance. In our effort to avail of these flexibilities, some of our health and trade officials were brought to court by Pfizer on specious grounds, specifically infringement of their patent rights. And in our advocacy and campaign to have these flexibilities reflected in the appropriate amendments to our Intellectual Property Code, the drug transnationals mounted a huge and expensive campaign to stop the approval of these amendments by our Congress and they even tried as well to misrepresent the position of the people fighting for these flexibilities, by raising the bogey of sub-standard and counterfeit medicines flooding the market.

Fortunately, at least for now, we survived the transnational campaign against our own legislative campaign to enshrine and incorporate these flexibilities into our existing IPC. Yes, we are bruised but we are victorious even for a moment, while the other side has been exposed as a selfish corporate lobby seeking to keep drug prices and profits high through their transnational monopoly hold on patents.

But let us not fool ourselves. The battle is not over, the fight has just begun. We have to anticipate the counter-attack of the transnationals in the bicameral deliberations on the proposed amendments. It is a foregone conclusion that they will still try to derail the final approval of said amendments and their enactment into law through various means. And even if they become law, they will not stop, they will continue the fight in the drafting of the implementing rules and regulations. They may even elevate the case to the appellate courts. It will surely be an uphill battle, as we are seeing now and as we have seen in our own Philippine experience with the generics. Through their expensive marketing and media programs, the transnationals have managed to hold back the development of the Philippine generics industry despite a two-decades-old enabling law.

This is why this conference is most important. We want to learn from one another on how to counter this transnational resistance and lobby, how to press governments to remain consistent and how to win the larger public to our side.

This is what we, at the Ayos na Gamot sa Abot-Kayang Presyo (AGAP), an alliance composed of representatives coming from organized groups such as the labor, health, industry, agriculture, and the consumer sectors, have been trying to do. We set up AGAP because we saw the need for a broad multi-sectoral coalition, which includes progressive officials and agencies in government, both in the executive and legislative departments. For the reality is that we can not help change policies and enforce measures that will bring down the prices of medicines in the country if we are badly divided and if we pit one sector against another, which is what the PR operators of the drug TNCs are trying to do.

In this regard, we need to build up unity based on principles and social partnerships, for this is the only way we can neutralize and overcome the power of the transnationals. Practical experience also tells us that we need to respect each other’s spaces and initiatives and unite on the basis of concrete principles and doables. So it is my fervent hope that this conference will discuss how different civil society groups, no matter how diverse, can unite in the campaign for WTO’s DOHA TRIPs flexibilities and affordable medicines.

I say this in all candor because I truly believe we are just at the beginning of a long and intermittent fight. We do need a bigger victory. We can only secure such victory if we are united and strong.

—————————

Speech delivered at the Regional Workshop on Access to Medicines organized by Oxfam-International East Asia, Third World Network (TWN), Department of Health (DOH), Ayos na Gamot sa Abot-Kayang Presyo (AGAP) Coalition, and Cut the Cost, Cut the Pain Network (3CPNet) , held at SEAMEO-Innotech, Diliman, Quezon City, March 15-16, 2007.

Regional workshop on access to medicines
Doha Development Round Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) and public health

The Intellectual Property Code of the Philippines (RA 8293)

The issue of access to medicines in Asia is very urgent considering there is no concerted effort among civil society groups to actively advocate for the implementation of World Trade Organization‘s Doha Development Round‘s Trade Related Aspects of Intellectual Property Rights (TRIPs) flexibilities among governments in the region. It must be acknowledged though that there are individual countries such as India, Thailand and Malaysia where successes are made, but there has to be greater effort to replicate these successes in other Asian countries.

It is for this reason that Oxfam-International East Asia, Third World Network (TWN) , Department of Health (DOH), Ayos na Gamot sa Abot-Kayang Presyo (AGAP) Coalition, and Cut the Cost, Cut the Pain Network (3CPNet) have come together to organize a Regional workshop on access to medicines on 15-16 March 2007 at SEAMEO-Innotech, Diliman, Quezon City to foster unity and linkages among civil society groups and key government agencies and strengthen their work on patents and medicines in Asia and build their capacity to understand and initiate efforts to challenge dubious drug patents in their countries or collectively in several countries in some important cases whenever these are found.

Regional forum concept paper and program
Location Map of the regional forum

The Philippines has the second highest drug prices in Asia
(From Newsbreak, December 4, 2006)

Wigberto E. Tañada, FTA Lead Convenor

Many Filipinos today are dying because they cannot afford expensive medicines prescribed by their doctors. In many cases, what seems to be a simple ailment becomes a serious threat to one’s health due to complications arising from inadequate medicines or failure to see a doctor regularly. Around 40 percent of Filipinos have never seen a doctor in their lives.

The prices of medicines in the country today are higher by 40 to 70 percent than in neighboring countries. The Philippines ranks second to Japan as the country with the highest prices of medicines in Asia. Our country’s medicines are 18 times more expensive than India’s or Canada’s.

Some of the country’s policies need reexamination. These include the laws on intellectual property rights such as patents and trademarks.

Certain provisions of the Intellectual Property Code (IPC) under Republic Act 8293 make it difficult for local drug manufacturers to secure compulsory licensing from research-based multinational companies. They are mired in litigation before they could even start negotiations.

Another difficulty is the inability to make parallel importation of cheaper drugs from India and Pakistan without being threatened with damage suits for supposedly infringing on patents secured by multinational companies in the Philippines.

On March 1 this year, one of the biggest pharmaceutical companies in the Philippines, Pfizer Ltd (UK), filed a suit against the Bureau of Food and Drugs (BFAD) and the Philippine International Trading Corp. (PITC). Pfizer claimed that PITC infringed on the Pfizer patent by importing an amlodipine besylate product and submitting it to BFAD for product registration.

The drug is marketed by Pfizer in the Philippines as Norvasc, which is normally used by patients as daily maintenance for the treatment of hypertension, angina, and myocardial ischemia. It is marketed in two dosage formats: 5mg tablet at P44.75 and 10mg tablet at P74.57. The same product under the brand name Amlogard is being sold by Pfizer in India at only P5.98 per 5mg tablet and P8.96 per 10mg tablet.

Pfizer Ltd. (UK) is the registered owner of Philippine Letters Patent 24348 on amlodipine besylate, which will expire on June 13, 2007. Pfizer Inc. is the exclusive licensee of Pfizer Ltd in the Philippines. It is asking the court to issue a temporary restraining order (TRO) to prevent PITC from making, using, or offering the sale or distribution of any Pfizer patent product while enjoining BFAD from entertaining applications for registration of amlodipine besylate by generic companies.

PFIZER CASE

What Pfizer wants is to extend its monopoly over the product by at least 18 months after its patent has expired. It may be noted that it takes 18 months for BFAD to evaluate an application for drug registration filed by a generic company. Essentially, this is the kind of “prejudice” that Pfizer accused PITC and BFAD of inflicting upon it. BFAD and PITC invoked Administrative Order 2005-001 issued by the Department of Health (DOH) dated Jan. 3, 2005, which states that “the DOH through BFAD is mandated only to ensure the safety, efficacy, and good quality of pharmaceutical products for registration. It has no mandate at all to pass upon intellectual property matters since it does not have the legal authority, resources, and competency to do so.”

PITC has not marketed or sold a single amlodipine besylate product in the country. It has no intention to do so until after the Pfizer patent expires in June 2007. Hence, the only issue is whether importing samples of a patented product such as Pfizer’s and submitting the same to BFAD for product registration constitutes infringement under IPC.

The case is still pending at the Makati Regional Trial Court under Judge Cesar Untalan, who favored a compromise agreement supporting Pfizer’s demand for PITC to stop any Pfizer product importation.

To many social development practitioners, the case is a clear example of harassment against government officials committed to do public service.

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