Loveless Christmas

Ten days before Christmas, I conditioned myself for the inevitable - for the 24^th time, I am celebrating a "loveless" Christmas. I still remember how I jokingly instituted an organization back in college called Samahan ng Malalamig ang Pasko (SMP). I was a proud president with only one member, a friend who was a freshman when I was a senior student in the university. Ten days before my 24^th Christmas, I was preoccupied with academic requirements, work assignments, scheduled Christmas parties and tasks for a Christmas outreach I volunteered to. My preoccupation was filled with all the worldly duties but never “romantic love.” During the times I managed to squeeze in moments for reflection, I only had one thought – what if my 24^th Christmas wasn’t loveless?

Five days before Christmas, I joined the Basket of Joy 2014 project of Initiatives for Social Action (ISA). The organization is a group of young professionals in the Philippines geared towards social involvement and nation-building. I was recruited by Jaypee Ortiz, a good friend and a fourth year law student, who founded the organization in 2011. We visited our Aeta brothers and sisters in Sitio Yangka, Capas, Tarlac. We brought little Christmas gifts and toys for the children. ISA also had a team of lawyers and paralegals from the Ateneo Human Rights Center (AHRC) and Legal Network for Truthful Elections (LENTE) who talked about ancestral domain and voter’s education.

 The community welcomed us with unfailing hospitality. The tatays helped us carry about 950kgs of goods to Sitio Yangka. The children even offered to help us with our personal bags during the hike. The children prepared an entertaining dance number with their native musical instrument. Each volunteer was given a necklace made of corn-like beads. Sitio Yangka prepared a bounteous lunch of cassava, banana, suman and fresh buko.

I was assigned to be the daughter of Tatay Junior’s family, with Cza, a fellow volunteer. His wife is Nanay Nena and they have five children – Romalyn, Lans, Pingay, Jeehan and Jessica. Our conversations revealed that the names of the children were suggested by previous volunteers who stayed with them for an immersion. I felt a bit pressured to be an excellent and loving volunteer then, if volunteers had that influence of suggesting names to their children. We were called ‘Nak by Tatay and Nanay. They fed us well with home-cooked meals. Tatay invited us to visit the place where they plant crops. We harvested vegetables that Nanay cooked for dinner. My sojourn in Sitio Yangka made me feel one thing – loved. My experience with ISA was an avenue to love and be loved.

I was glad to realize five days before Christmas that I’m not celebrating it loveless. I never celebrated it loveless all this time. Five days before Christmas, I stopped calling my Christmas loveless (just because I didn’t have it the romantic way). There are various manifestations of love whether as the giver or the receiver. The volunteers showed love by offering themselves to Sitio Yangka. The Aeta families loved us even if were just visitors there for a short while. Jaypee showed his impeccable love for Sitio Yangka and ISA volunteers. I felt loved by my newfound friends from ISA. I was inspired to be more loving by dedicating my God-given talents to things worth doing, with people worth being with.

Five days after Christmas, I no longer blame my night classes which prevented me from completing the nine nights of Simbanggabi for my Christmas wish – love. Five days after Christmas, my experience in Sitio Yangka enriched my heart with a more genuine definition of love – love that is directed towards the others, one that transcends romantic love. Though I do not discount the power of such love, I probably will have to complete the next year’s Misa de Gallo for that!

Filipino Workers: The Generation of Online Freelancing

“Work differently.”[1] “Love the way you work.”[2] I have been an online freelance writer for three years now. Three years ago, I was a freshman law student looking for work to finance my school allowance. I initially tried to look for a tutorial job since it has been a “comfort zone” for me during my university years. Unfortunately, I was unable to find some openings in the Makati area, an exact contrast to the situation I had in Katipunan where I would usually find a tutorial center within a fifty step walk. Not finding a tutorial job meant saying good bye to younger students calling me “Teacher,” “Ate” or “Atsi.” I had to look for an alternative. I could not manage a full-time office work because it would surely conflict with my class schedule. I started browsing JobStreet and researching for work online, until I was advised that the solution might be there – online!

I started making an account and building my portfolio on an online platform. An online platform is like a market where clients and freelancers meet. As a newbie in the online freelance community, it was difficult competing with other freelancers who have been working on the online platform for several years already. I had to lower my rate and tried hard to please my clients that my friends would ask why I subjected myself to “consensual exploitation.” Luckily, I was able to build relationships with some clients who would initiate the contact whenever they had some projects that I could work on.

Online freelance work is often based on trust, than on written job contracts. It is based on trust that the freelance worker will submit a quality work on time, and that the client will pay the freelance worker upon submission. In general, I would say that some clients are trustworthy. I had clients who later on became my “friends,” making sure to Skype me on my birthday and even telling me about their trips to Europe, Christmas celebrations, or simple school achievements they had. During Yolanda, a client even sent me a long email asking how my family was.

In a short period of time of working online, I realized that there is still a lot to improve in the online freelancing industry. While I have been reading news about the flexibility of online work and how some freelancers managed to earn a million in just one year, I still have some issues on the sustainability of this industry because of the lack of specific regulations and legal protection afforded the freelance workers. The following are some observations:

1.       Employer-employee relationship. Studying the Labor Code in my junior year, a puzzle started to trivialize my thoughts on the work relationship between the client and the freelancer. There is likelihood that freelance workers are not classified as “employees” and thus not protected with several labor benefits available to workers. If there is any, the contractual stipulation would often define the freelancer as an “independent contractor” even if the four-fold test of an employer-employee relationship can be satisfied: power to hire; power to fire; compensation; control. While this innovative form of work affords flexibility to the Filipino workers, it also poses a threat of taking away some constitutional rights of workers: self-organization; bargaining and negotiations; peaceful concerted activities; security of tenure; just and human conditions of work; living wage; right to participate in policy and decision making.

2.       Social security and health benefits. I know a couple of freelance workers like me and there is usually one thing in common: We do not maintain our own Social Security System (SSS) account as self-employed individuals nor even have our own PhilHealth or other health insurance. The negative impacts of not having an SSS or a PhilHealth account may not be noticeable until a person retires, gets sick with the need for hospitalization or other fortuitous events. The lack of social security for the freelance workers poses a risk, especially with the increasing number of freelancers who look into the industry as a source of living in the long-run. If this phenomenon continues, the Philippines may have a considerable number of Filipinos without social security in their old age 20 years from now.

3.       Security of tenure. On the online platform that I first worked with, I have lost jobs and clients like I have lost my room and locker keys. The reasons vary: The client did not like my work; I was not able to meet the deadline because I also had to study for an exam; and others. In the traditional form of work within the ambit of the Labor Code, security of tenure is guaranteed and a worker may only be dismissed for just and authorized causes. In online freelancing industry, the just and authorized causes of termination are most often discretionary on the part of the clients. Further, the freelancers do not have the benefits of separation pay usually available to the traditional form of employment.

4.       Unsecured payments and compensation. As of this writing, I have probably had more or less a hundred pages of unpaid work. Some clients are unresponsive after submission of the work. Some would say they are not satisfied with the output and expressly state that they will not give the agreed compensation. Some would tell that they are already sending the payment only to wait for it for weeks before finally realizing that it is never coming. It is part of the risk that freelancers have to take.

Despite the negative factors associated with online freelancing industry, I would still rate it positively, than negatively. On a national scale, online freelancing has certainly fed families, “employed” individuals who would otherwise be unemployed, underemployed or printing their resumes to spend each day falling in line for job interviews. Freelancing helped me deal with tough work deadlines while studying for the daily grind of law school. My work made me learn different academic citations and equipped me with working knowledge on different topics - luxury bags, cars in the 80s, transformational leadership, political strategy of Putin, the invisible hand, Lolita by Nabokov, cloud computing, and many more. It made me take that "leap of faith" going to classes, knowing I have read more academic journals for work, than case digests for my law subjects. Freelancing allowed the 24/7 green dot on my Facebook chat box while my legs were trembling, fingers shaking, while trying to vomit words to meet the page count for the last 30 minutes of work before it’s considered late. I dream of the day when the online freelancing industry is safeguarded with legal protection. I dream of the day when every online Filipino freelancer is proud to say that “I work differently and I love the way I work.”

---

[1] Tagline of Elance, available at elance.com.

[2] Tagline of oDesk, available at odesk.com. 

Before saying "hello" to the daily grind, THANK YOU!

I promised myself to write something about my thesis when I feel like “I gave this envelope the justice it deserves.”

Thank you to my adviser, Atty. RYAN QUAN. Thank you for giving me the thesis topic and for guiding me throughout the writing process. Thank you for reading my thesis and giving insightful comments on how I should revise it, to make sure it was ready for submission. Thank you for introducing me to your connections in the field of environmental law. I will definitely miss you when you leave for Masters but like all the interns, I wish you all the best.

Thank you Atty. ARPEE SANTIAGO, for your comments regarding my thesis topic and my legal issue. You are always an inspiration to the AHRC interns.

Atty. ALU DOROTAN, thank you for all your insights and assistance in writing my thesis. I am grateful for your books and affirmation that I have a legal issue.

Atty. MONALISA DIMALANTA, thank you for accommodating me to your busy schedule. Thank you for your insights and for your time. You inspire me to want to become an Energy lawyer someday. 

Atty. TONY LA VINA and Atty. ANTONIO OPOSA, thank you for entertaining my queries. Receiving replies from you will always be the highlight of my inbox. Great advocates! 

My QUISUMBING TORRES (QT) bosses <3

a) Atty. JARED AMOROSO, I was really happy to know we were both members of AHRC. Thank you for your suggestions on "what to do" when I was really confused on how to go about my thesis, three weeks before the deadline. Thank you for showing the interns of how great litigation/arbitration work is.

b) Atty. BRYANT CASIW, thank you for the comprehensive list of possible thesis topics. You have always been one of my "life peg[s]" because of your brilliance and good personality. I have always admired you ever since the interview.

c) Atty. LEM LOPEZ, thank you for responding to my messages. Thank you for giving me possible thesis topics. I am forever glad to have met people like you in the legal profession.

d) Atty. JON ZUNIGA, whose passion for labor law has always inspired me. I have always wanted to write a thesis on labor, more than anything else.

My internship with VILLARAZA AND ANGANGCO also gave me the opportunity to meet lawyers and randomly talk about my thesis topic last summer. Atty. DARWIN ANGELES, thank you for giving me possible thesis topics. They were all brilliant topics. You are definitely one of my idols in legal writing.

Thank you to my sisters from THE WOMEN OF ALEITHEIA, for your time in reading my thesis and doing my mock defense. I especially thank my senior batchmates, RAX, GAY, Ate HYE and Sis IDESA for your invaluable contribution to the preparation for my defense. 

Thank you to my peers in the ATENEO HUMAN RIGHTS CENTER. You really are my family in law school. Special thanks to my beloved batch BULAN <3 and to our MARASANG babies who helped me in my mock defense. Thanks JEI for being there <3, LUCY for arranging the mock defense, MARIE and TRIXIE for being there and texting me <3, Baby Boy RAYMOND I was super touched, KIICHI, LEIA, CAMILLE and LYN for moral support. Thank you PAU and CHELS! Thank you for the inspiration to always (try to) make a difference.

Thank you to THE PALLADIUM. Without the org room, I don't know where I could have written my thesis during the nights my internet at home failed me. 

Thank you BLOCK A for being the most supportive block ever. Thank you for helping me in my mock defense and for always being #Astrong, a source of strength amidst our #unlipoli while writing thesis and preparing for defense.

Thank you GERALD, for saying "yes" to my request that I really needed a "win or lose" friend to be with me there. It meant the world to me. Thank you for being my science and life coach. Your friendship will always be something I want to treasure in this lifetime.

Thank you RHEA, for always being a "sunshine" to everyone. Thank you for all the positive vibes and the words of encouragement. Meeting you in law school was one of the best things that happened here.  

Thank you JAYPEE, for spending the last nights of thesis-writing with me (i.e. *cramming* with me). You are definitely one of the most inspiring people I have met in law school (or even in life). Thank you for the smocket conversations, panic attacks and great life stories.

Thank you Ate AMAM, for comprehensively replying to my questions about science. Thank you for being a friend. My college life was somehow defined by your presence in my life!

Thank you COLEEN, for spending your precious time to listen to my defense speech. It meant a lot because you could have spent the time preparing for the bar. Thank you RESPI for listening to my speech and giving constructive comments and questions. 

Thank you CRISELLE, for talking to me when I felt like I could not even do my normal routine because I was too scared of what was going to happen.

Maraming salamat MATANGLAWIN sa tuwinang pagkakaibigan at inspirasyon.

Thank you to the members of my panel. Thank you to my family and friends. Thank you Lord! #AMDG

Rainy Nights

It was a good night: Your voice turned the sound of the rain into magical droplets of hope. Your smile brightened an otherwise gloomy night. How I realized a rainy night has its perks: If I forgot my umbrella, you also forgot yours, while the rain was oblivious of what it meant to stop itself. We were there exchanging: Words  Let tonight be the first of the many rainy nights.

A PLAIN OF THEIR OWN: What Happens After the Expiration of CARPER?

For several decades now, the plight of the Filipino farmers has reached plateaus of triumphs and valleys of failures – mostly based on the legal and socio-political fluctuations in the administration of agrarian reform. The issues on land acquisition and distribution have been heightened by the proactive participation of different societal sectors to bolster the claims of the Filipino farmworkers. The broadcast and print media widely publicized the fate of the Sumilao farmers (1700 kilometer march for agrarian justice from Sumilao, Bukidnon to Malacanan) and the farmworkers of Aurora who were affected by the creation of the Aurora Pacific Economic Zone (APECO). The most recent and pressing concern in agrarian reform was the expiration of the Comprehensive Agrarian Reform Program Extension with Reforms (CARPER) last June 30, 2014. It is a paradox in the agricultural sector that the legal basis of what the farmers have been fighting for, has just expired, even before the Filipino farmworkers found their way to the plain of consistency and stability – a plain they can till, cultivate and call their “own.”

Agrarian Reform

As an agricultural country, it is of utmost importance that the agricultural sector is given ample protection by Philippine laws. Agrarian reform has been a continuing concern in the Philippines. Agrarian reform is a Constitutional mandate and is protected by the highest law of the land. It is the policy of the State to promote a comprehensive rural development and agrarian reform (1987 Constitution). Further, the agrarian reform program should be founded on the right of the farmers and farmworkers (1987 Constitution). It is noteworthy that the overarching goal of agrarian reform is countering the continued marginalization of the agricultural sector and ensuring that social justice is fully realized by Filipino farmers.

The Constitutional recognition of the importance of the agrarian reform program was expressed in the transitory provision requiring the expropriation of agricultural lands, for distribution to the beneficiaries of the agrarian reform program, at the earliest possible time (1987 Constitution). To facilitate agrarian reform in the country, the Department of Agrarian Reform (DAR) was specifically created to implement agrarian laws and ensure the realization of this social policy.

CARP and CARPER

The most important legal tool in the field of agrarian reform is the Comprehensive Agrarian Reform Program (CARP), which aimed to grant landless farmers and farmworkers, ownership of agricultural lands. The basis of this program is Republic Act No. 6657, otherwise known as the Comprehensive Agrarian Reform Law of 1998 (CARL). The law placed the welfare of the landless farmers and farmworkers to receive the highest consideration, pursuant to the principle of social justice. Further, the policy of the State to promote a sound rural development and industrialization coincided with the principles behind the CARP. The beneficiaries of the CARP include the landless farmers, agricultural lessees, tenants, seasonal and other farmworkers. The implementation of the CARP is a joint duty among many government agencies. The DAR and the Department of Environment and Natural Resources (DENR) are the lead agencies as these are in charge of the identification and distribution of “CARPable” land.

The CARP was strengthened by the Comprehensive Agrarian Reform Program Extension with Reforms (CARPER), otherwise known as Republic Act No. 9700. The CARPER extended the deadline for the distribution of agricultural lands to farmers for five years.  It has been five years since the amendatory law became effective on August 7, 2009. According to a commentary by Walden Bello (Philippine Daily Inquirer, June 10, 2014), the CARPER is a powerful law when the following provisions are taken into consideration:

Sec. 5 of CARPER, amending Sec. 7 of CARL	Outlawed voluntary land transfer used by landlords to retain control of land via the "Stock Distribution Option" as a method of land redistribution
Sec. 21 of CARPER, amending Sec. 63 of CARL	P150 billion budget for land acquisition and support services
Sec. 9 of CARPER, amending Sec. 24 of CARL	Indefeasibility or non-revocation of Certificates of Land Ownership Awards (CLOAs) and Emancipation Patents (EPs)
Sec. 23 of CARPER, amending Sec. 68 of CARL	Immunity of DAR from temporary restraining orders or injunctions in the implementation of the agrarian reform program
Sec. 22 of CARPER, amending Sec. 65 of CARL	Irrigated and irrigable lands as non-negotiable for land conversion

The most significant aspect of CARP to the Filipino farmers is land distribution. Land distribution and acquisition is initiated by a Notice of Coverage (NOC), a letter informing a landowner that his/her land is covered by CARP, and is subject to acquisition and distribution to beneficiaries. It likewise informs the landowner of his/her rights under the law, including the right to retain 5 hectares (Official Gazette). The issuance of the NOC is significant vis-à-vis the June 30, 2014 deadline because the law allows the continuation of land distribution proceedings as long as they have already been initiated.

Achievements of the CARPER

            The government released an update on the accomplishments in the field of agrarian reform, as of June 30, 2014. "As of December 31, 2013, the government has acquired and distributed 6.9 million hectares of land, equivalent to 88% of the total land subject to CARP" (Official Gazette). The Aquino administration has distributed a total of 751,514 hectares from July 2010-December 2013 (Official Gazette).

Despite the achievements of the CARPER up to date, the implementation of the program is not totally free from public scrutiny. Admittedly, the DAR recognizes the challenges posed by the full implementation of the CARPER. The agency cited the erroneous technical descriptions in the land titles as one of the barriers to the prompt distribution of land (Official Gazette). Titles to some land were also destroyed, necessitating court proceedings for the reissuance of titles (Official Gazette). The legal process guaranteeing the landowners' right to due process has also been cited as one of the hindrances to land distribution (Official Gazette). An example would be when the landowners petition for exemption or exclusion of their lands from the ambit of the CARP (Official Gazette).

Expiration of the CARPER

June 30, 2014 marked a significant day in the history of CARPER - the finish line. Section 5 of the CARPER Law provides that "the final acquisition and distribution of all remaining unacquired and undistributed agricultural lands from the effectivity of this Act until June 30, 2014." One interpretation of CARPER is that land acquisition and distribution shall be barred by June 30, 2014. This is based on the provision of Section 7 of CARP Law, as amended by CARPER saying that "Land acquisition and distribution shall be completed by June 30, 2014 on a province-by-province basis." Several socio-political movements lobbied for the full implementation of CARPER by extending the date to ensure that the “CARPable” lands are distributed to the beneficiaries under the law.

It is noteworthy that CARPER Law also mandates that “any case and/or proceeding involving the implementation of the provisions of Republic Act No. 6657, as amended, which may remain pending on June 30, 2014 shall be allowed to proceed to its finality and be executed even beyond such date” (Sec. 30 of CARPER). Using this provision, the expiration date should be immaterial to the proceedings where NOC have already been issued. The problem arises for the “CARPable lands” for which no NOC has been issued yet. There is a view that for cases where NOC has been issued, the initiation of proceedings is forever barred due to the expiration of CARPER. As of press time, this remains a question that only an enabling law can solve.

A Long Way to Go

            As a program enshrined in the Constitution, the end should not be defeated by mere legal limitations of expiration. Almost a million hectare of land has yet to be acquired by the government for distribution in the 2014-2016 period  - 771,795 hectares and 134,857 hectares for DAR and DENR, respectively (Official Gazette). The following table shows the target number of land hectares for distribution as released by the Official Gazette:

Year	Number of Hectares
2014	187,686
2015	198,631
2016	385,478

The target number of hectares schedule per year is not without any uncertainty as 551,275 hectares of the CARPable landholdings to be distributed are considered workable, while 220,520 hectares are labelled as problematic (Official Gazette). With an efficient and dedicated process, the future distribution will be a milestone success to the Filipino farmers and to the Philippine agricultural sector.

The distribution of agricultural lands to the landless farmers should be fully realized even after the date mandated by the law, in order to fulfill the intent of the highest law of the land. In fact, the nature of CARP as a continuing program is recognized by the Department of Justice (DOJ) Opinion 9, series of 1997 where it was mentioned that the program does not end until the scope and mandate is completed (Bag-ao, 2012). The legal basis for the continuation of land acquisition and distribution is found on the CARPER Law. Section 30 of CARPER Law mentioned that “Any case and/or proceeding involving the implementation of the provisions of Republic Act No. 6657, as amended, which may remain pending on June 30, 2014 shall be allowed to proceed to its finality and be executed even beyond such date.” A NOC initiates the land distribution proceedings. Based on Sec. 30 of the CARPER Law, the landholdings with NOC can be distributed even beyond June 30, 2014.

            The continuation of land distribution is supported by DAR. Further, the 2014 General Appropriations Act also bolsters the continued distribution of land since there is still money appropriated for the program. Despite the governmental support to the continuation of land distribution, it is undeniable that there are also challenges that counter the full realization of land distribution to the farmers. Cases are pending before the DAR Adjudication Board (DARAB) and judicial courts to revoke CLOAs based on the argument that the lands distributed were not covered by CARP. The law is bereft of an expiration period or legal limitation, other than those available in remedial law, on when the private landowners can assail the “CARPable” characteristic of their land. Once ruled by the courts as not “CARPable,” the farmers who were once victoriously awarded with CLOAs, might end up losing their rights.

An effective agrarian reform program is one that promotes the Constitutional policy founded on the rights of farmers and farmworkers. In as much as several stakeholders also play a part in the implementation of CARP, a system of a just and fair land distribution should be the primary consideration. Certainly, agrarian reform and remedial laws should not be utilized as tools to defeat the rights of the farmers after they have fought a Herculean task of going against the legal system, the powerful landed elite and the “ineffectual bureaucracy” of the Philippine government. The Filipino farmers definitely deserve a plain of consistency and stability – a plain they can till, cultivate and call their “own.”

Sources

1987 Philippine Constitution.

Republic Act No. 9700, An Act Strengthening the Comprehensive Agrarian Reform Law [CARPER], 2009.

Republic Act No. 6657, Comprehensive Agrarian Reform Law of 1998, 1998.

Official Gazette, Q and A: The Comprehensive Agrarian Reform Program, 30 June 2014, available at http://www.gov.ph/2014/06/30/q-and-a-the-comprehensive-agrarian-reform-program/

Bag-ao, Kaka, Queries on CARPER Beyond 2014, 1 June 2012, available at https://m2.facebook.com/notes/atty-kaka-j-bag-ao/queries-on-carper-beyond-2014-legal-notes-of-akbayan-rep-kaka-bag-ao/10150887969494751/?_rdr.

Bello, Walden, Agrarian reform: Powerful law, ineffectual bureaucracy, PHIL. DAILY INQ., 20 June 2014, available at http://opinion.inquirer.net/75458/agrarian-reform-powerful-law-ineffectual-bureaucracy.

It's when I'm writing 

That I miss you most, Of the time

I remember 

How you gently stroke letters on 

A smooth and clean sheet of

Paper 

And remembered

I wished

You'd grab my hand

"not even the rain has such small hands"

That took (and drowned) me to places

I'll remember

The Philippine Pharmaceutical Industry through “Rose-Colored Spectacles”: Cheap Medicines Act vis-à-vis the Intellectual Property Code

Introduction

The paper aims to illustrate how the Philippine legal framework is able to balance the government’s duty to promote health[1] and public welfare, with the constitutional[2] and statutory right of persons, whether natural or juridical, to intellectual property rights. In analysing the constitutional mandate, the paper will cover the pertinent provisions of both international and domestic legal system. The international law applicable would primarily pertain to the Agreement on Trade-Related Aspects of Intellectual Property Rights[3] (TRIPS). The author decided to consult with relevant laws and jurisprudence of other states and regional organizations that have persuasive effect to the Philippine legal system. The domestic laws to be examined include the Intellectual Property Code vis-à-vis the promulgated law on Access to Cheaper Medicine.

The paper is divided into five parts. The first part of the paper is about the pharmaceutical industry using the intellectual property law as framework of the discussion. This includes analysis of the dynamics of pharmaceutical companies with the laws on patent, compulsory licensing and parallel importation. The second part of the paper discusses the concept of the “Bolar Exemption.” This includes the introduction of the etymology of the term which traces its roots from American jurisprudence. This part of the paper will also present the international and regional bases of this exception. The next part of the paper will tackle the Access to Cheaper Medicine Act, a law supporting the exception of health as a more compelling interest over intellectual property rights. This law is labelled as the Philippine version of the Bolar Exemption. The fourth division shows the legal trend among other areas of law, where health and medical research are tagged as exceptions to the rule covered by the general provisions. The last part of the paper is the analysis and conclusion. This part will present a brief summary of the preceding divisions of the paper. The author opines that the higher level of importance accorded the public health over the intellectual property rights of the pharmaceutical industry should go beyond superficial legislation in order to meet the “public interest” ends and satisfy the due process requirement in the “deprivation” of constitutional right to property.

Pharmaceutical Products and Intellectual Property Law: Patenting, Compulsory Licensing and Parallel Importation

Patent

A patent is granted by the government to protect new and useful inventions. By virtue of this right, the patentee is able to exclude others from making, offering for sale, using or selling an invention.[4] The Intellectual Property Code of the Philippines, also known as Republic Act No. 8293 (R.A. 8293) includes “any technical solution of a problem in any field of human activity which is new, involves an inventive step and is industrially applicable”[5] as patentable. As a general rule, the patent of pharmaceutical products accords present rights to the patentee and deals with sustainability of the invention by making sure that the salient information will be used by the public after the expiration of the patent. As adapted by Pearl & Dean (Phil.), Incorporated v. Shoemart, Incorporated[6]:

The patent law has a three-fold purpose: "first, patent law seeks to foster and reward invention; second, it promotes disclosures of inventions to stimulate further innovation and to permit the public to practice the invention once the patent expires; third, the stringent requirements for patent protection seek to ensure that ideas in the public domain remain there for the free use of the public."[7]

Under Section 72 of the same Code, the law explains the limitations of patent rights on drugs and medicines after a drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent owner, or by any party authorized to use the invention.[8] Application for patents are done through the Intellectual Property Office of the Philippines (IPO).The term of protection awarded the patentee is 20 years which accords the inventor pecuniary and commercial gain. The patent owner shares the full description of the invention and this data can be used for future research after the period of exclusive use expires.[9]

Compulsory Licensing

Certain flexibilities on the application of the stringent rules on intellectual property are recognized by international agreements. To give an example, the Doha declaration on TRIPS provides that member states are allowed to utilize compulsory license during health crises and emergency to supply sufficient medicine to the public.[10] Compulsory licensing is explicitly recognized by the Philippine IP Code. Compulsory license is a grant given by the government in favour of any person who has shown the capability to exploit the invention under certain circumstances.[11] One recognized circumstance is “public interest, in particular, national security, nutrition, health.”[12] Pursuant to the power of the government to pursue public interest, the legislative branch enacted Republic Act No. 9502, also known as the “Universally Accessible Cheaper and Quality Medicines Act of 2008.” This law will be more comprehensively discussed in the succeeding sections of this paper. It should be noted that as opposed to patents and parallel importation, the Philippine Supreme Court is yet to decide a case on compulsory licensing based on R.A. No. 9502.

Parallel Importation

            Parallel importation is also a relevant topic in the Philippine drug industry. According to Solid Triangle v. Sheriff of RTC QC, a parallel importer is “one which imports, distributes, and sells genuine products in the market, independently of an exclusive distributorship or agency agreement with the manufacturer.”[13] In the pharmaceutical industry, parallel importation involves the purchase of a patented drug from an approved source in an exporting country where it can be acquired more cheaply, without the consent of the patent holder in the importing country.[14] Parallel importation is supported by Article 31(5) of TRIPS which allows member states to enforce flexibilities in the enforcement of intellectual property rights when there is a national emergency or other circumstances of urgency. Parallel imports are also called grey-market imports. These imports do not involve the importation of counterfeit products or illegal copies.[15] As defined by the World Trade Organization (WTO), “These are products marketed by the patent owner (or trademark or copyright owner, etc) or with the patent owner’s permission in one country and imported into another country without the approval of the patent owner.”[16]

The Bolar Exemption

            The Bolar Exemption has its legal basis in Article 30 of TRIPS which provides the exceptions to rights conferred the patentees. The provision states, “Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not reasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.”[17] The Bolar Exemption, although may be characterized as a unilateral act of the government because it does not require the consent of the patentee, does not unjustly disregard the economic rights of the patent grantee. The exemption is about striking a convergence between the promotion of invention and the accessibility of cheaper medicine which is an important factor in sustaining a healthy population. The milestone achievement created by the Bolar Exemption is the allowance of acts of experimentation and research even before the expiration of the patent of a pharmaceutical product.[18]  In developing countries like the Philippines, this is a necessary government intervention to also protect the rights of majority of the Filipinos who normally would not have access to expensive medicinal products.

            In the international arena, both developed and developing states have acknowledged the importance of the Bolar Exemption for the promotion of human health and medical research. In a Government Response published by the Intellectual Property Office of the United Kingdom in 2013, the Government accepted that section 60(5) of the Patents Act of 1977 should accommodate the exemption from infringement, the activities involved in the preparation or running of clinical or field trials involving innovative drugs.[19] Furthermore, the Government Response opted for the inclusion of the activities involved in health technology assessment (HTA).[20] The state is on its way to developing amendments to the laws governing intellectual property on pharmaceutical products.

            The Bolar provision of the European Union is also known as Directive 2004/27/EC. This is the directive on the amendments on the Community Code relating to medicinal products for human use. By virtue of the directive, the rights granted to the patentee by virtue states’ laws on patents and utility model do not extend to trials and studies as defined by the directive. The directive is of extreme significance because prior to its enactment (before 19 November 2005), clinical studies and other relevant processes for the development and innovation of generic medicine could be tantamount to a patent infringement.[21] The directive is labelled as an upside to the manufacturers of generic drugs while also considered as downside from the perspective of the mainstream pharmaceutical companies.[22] The implementation of the Bolar provision in the European Union shows the support of the intergovernmental entity to the value of innovations that are not barred by technicalities governing patent laws.

            The application of the Bolar Exemption can have serious consequences to the mainstream pharmaceutical companies. In a press release created by Novartis, the corporation manifested its proactive cooperation to the exemption:

The manufacture, sale, use or importation of a patented product without permission by the patentee constitutes infringement in most countries. The “Safe Harbor exemption” is an exception to this rule. It is widely accepted that patents are an instrument to promote and not to hinder research activities. xxx Clinical trials for both generics and innovative medicines should be exempt in the interest of bringing new innovative and affordable medicines to the patients without any unreasonable delays due to patent protection.[23]

In another state, Pfizer, another international pharmaceutical company questioned the retroactivity of the Bolar Exemption.[24] The Supreme Court of Spain decided in favour of Spain and confirmed that the Bolar provision which was incorporated in Spanish laws in 2006 has a non-retroactive character. Therefore, prior to its enactment in 2006, the Bolar exemption did not exist in the Spanish jurisdiction.[25]

Universally Accessible, Cheaper and Quality Medicines Act of 2008

Based on studies, drugs in the Philippines are more expensive that drugs in other Asian countries of similar economic status. Because of this data, the government was impelled to institute the Cheaper Medicines Program through the Universally Accessible, Cheaper and Quality Medicines Act of 2008 which provided for the prominent legal bases for parallel importation[26] and improved production of generic drugs.[27] It cannot be avoided that because of the controversial amendments introduced by the law, the constitutionality of the provisions has been challenged by interested parties. The validity of the provision on parallel importation has been affirmed in the case of Roma Drug v. RTC of Guagua[28], which recognized the legality of grey importation as supported by the amendment to Section 72.1 of the Intellectual Property Code and the Implementing Rules[29] of R.A. No. 9502.

In the same manner, this law is instrumental in the allowance of research and laboratory trials even prior to the expiration of patent, pursuant to the regulations to be imposed by the government. The Bolar counterpart is found in Section 7 of  R.A. No. 9502 which provides an amendment to the IP Code.

72.4. In the case of drugs and medicines, where the act includes testing, using, making or selling the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product: Provided, That, in order to protect the data submitted by the original patent holder from unfair commercial use provided in Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), the Intellectual Property Office, in consultation with the appropriate government agencies, shall issue the appropriate rules and regulations necessary therein not later than one hundred twenty (120) days after the enactment of this law.[30]

R.A. No. 9502 also expressly amended the Generics Act of 1988. In a commentary from an Intellectual Property Law Firm[31], the commentator differentiated the Cheaper Medicines Act with the Generics Act:

The new law now allows local generic companies to start studying and testing generic equivalents of patented drugs before the expiration of the patent. This will also allow pharmaceutical companies to start the production and sale of a generic drug upon the patent. Under the old law, this preparation could only be done after the patent has expired. The whole process of obtaining approval for the drug, takes roughly about three years, effectively delaying the introduction of the generic in the market. In this manner, therefore, a patent-holder’s monopoly in local commerce over the drug, and any of its equivalents, were inadvertently extended by this period, outside the duration guaranteed the patent-holder by the law.[32] 

Medicine and Health as Exceptions: Other Areas of Law

Matters relating to medicine and research for the improvement of health condition are recognized exceptions among laws, not just on intellectual property but also on competition and privacy. The domestic and international laws and policies recognize the prime importance of health. The vital significance of the human person goes beyond the property rights of inventors and allows for the relaxation of strict rules on intellectual property when the public interest is at stake. This part of the paper will discuss the Data Privacy Act of 2012 and the ASEAN Regional Guidelines on Competition Policy – two areas that acknowledge the transcendental importance of human life as opposed to the inventor’s rights of pharmaceutical companies to privacy and market competition.

 Within the purview of the law on privacy, there are two primary uses of personal data within the pharmaceutical industry: biomedical research and pharmacovigilance. On the one hand, biomedical research recognizes that life-saving treatments available today were made possible by an environment that fostered medical research. Pharmaceutical companies collect patient health information created in controlled research settings.[33] On the other hand, pharmacovigilance is the science of activities relating to the detection, assessment, understanding and prevention of drug adverse effects or any other drug-related problem.[34] The Data Privacy Act recognizes that “it is the policy of the State to protect the fundamental human right of privacy, of communication while ensuring free flow of information to promote innovation and growth.”[35] The flow of ideas for the propagation of intellectual growth for public welfare should never be hampered. This is another field of law where disclosure is favored over secrecy in order to serve public interest.

Competition laws also provide for exceptions to pharmaceutical products and medical research. This further reiterates the importance of public health that should be given proper attention. Under Section 3.5.6 of the ASEAN Regional Guidelines on Competition Policy, “AMSs may use block exemptions xxx to exempt specific sectors and/or types of economic activities from the application of competition law. Examples of common industries or activities which may be granted block exemptions include research and development cooperation, and intellectual property rights contracts.”[36] The regional block of the Southeast Asian nations also recognize that exceptions to the competition policy can be made if based on public policy[37] grounds.

Analysis and Conclusion

            An analysis of the exceptions and exemptions granted by the Cheaper Medicines Act reaffirms the essential role that public health plays to achieve public welfare. Indeed, the legislation on the promotion of medical research and clinical trials even when there is an existing patent is primarily rooted on the desire to make pharmaceutical products more accessible to the public. In spite of the genuine communal benefit that is aimed to be achieved by the law, the words framed by the legislature should be fitted with the reality experienced by the consumers.  To give an illustration, surveys should be conducted in order to determine whether or not the implementation of the law is appropriate its objectives. Otherwise, the government intervention might be tantamount to lost revenues for mainstream pharmaceutical industries without reaping the benefits on the other end of the pole. The government is also bound to respect the property rights of pharmaceutical companies over their inventions. It is only when two conflicting interests need to be decided upon, that public health is given more weight.

As of press time, the use of generic medicine across the country may be prevalent but there are valid criticisms[38] that need to be addressed in order to ensure a more efficient implementation. The effectiveness of the provision on compulsory licensing as provided by the Cheaper Medicines Act is yet to be proven. The lack of sufficient basis to evaluate compulsory licensing can be attributed to the fact that the Philippines has not recently experienced health crisis that is sufficient for a compulsory license to be granted. Viewing the health condition and the need for accessible and cheaper medicine in the Philippine setting using the framework of the Cheaper Medicines Act and its amendment to the IP Code is akin to perceiving reality through “rose-colored spectacles.” On the one hand, there are times when the Philippine situation should be analysed with a naked eye. On the other hand, is the recognition that the government with its three branches, is capable of making the “rose-colored spectacles” more vibrantly red by ensuring that appropriate legislations are implemented effectively.

References

Primary Sources

1987 Philippine Constitution.

Data Privacy Act of 2012, R.A. No. 10173.

Intellectual Property Code of the Philippines, R.A. 8293.

Implementing Rules of R.A. No. 9502.

Rules and Regulations Implementing Republic Act No. 9711.

Association of Southeast Asian Nations. (2010).  ASEAN Regional Guidelines on Competition Policy.

Trade Related Aspects of Intellectual Property Rights (TRIPS).

Pearl Dean (Phil.), Incorporated v. Shoemart, Incorporated and North Edsa Marketing, Incorporated, 409 SCRA 231, August 15, 2003.

Solid Triangle v. Sheriff of RTC QC, G.R. No. 144309, November 23, 2011.

Roma Drug v. Regional Trial court of Guagua, G.R. No. 149907, April 16, 2009.

Secondary Sources

Ambrocio, K. (2009). The Bolar Exception: Roots and Introduction to the Philippine Patent System. Accessed on 8 October 2013 fromhttp://www.iplaw.ph/ip-views/The-Bolar-Exception-Introduction-Philippine-Patent-System.html.

Borchard, W. (2012). A Trademark is not a copyright or a patent. Cowan, Liebowitz & Latman, P.c., New York.

CMS. (2007). Bolar Provision and Regulatory Data Exclusivity in Europe. Accessed on 8 October 2013, from http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf.

Cole, G. Exemption from Infringement: the EU Bolar Directive. IP Europe Quarterly. Accessed on 8 October 2013, from http://www.avidity-ip.com/assets/pdf/BolarJun12.pdf.

Gerharsen, T. (2006). Pfizer Fights IP Flexibilities in the Philippines. Accessed on 8 October 2013, from http://www.ip-watch.org/2006/04/30/pfizer-fights-ip-flexibilities-in-the-philippines/.

Intellectual Property Office. About Patents. Accessed on 8 October 2013, from http://www.ipophil.gov.ph/index.php/patents.

Intellectual Property Office of the United Kingdom. (2013). The Research and Bolar Exception: Proposals to exempt clinical and field trials using innovative drugs from patent infringement.

International Pharmaceutical Privacy Consortium, 6 March 2012.

Lovells, H. (2010). Spanish Supreme Court rules on Bolar and experimental research exemption. Accessed on 8 October from http://www.lexology.com/library/detail.aspx?g=20f5c6aa-fa61-47d1-b680-d632f76110ce.

Manthan, J. (2008). Patents Regime in India: Issues, challenges and opportunities in Pharmaceutical Sector. Vol. 7, Issue 1, Journal of Third World Medicine.

Novartis. (2011). Safe Harbor Exemption (Bolar Provision).

Ocampo, S. (2012). Cheaper medicines law hasn't served the poor. Accessed on 9 October 2013, from http://www.philstar.com/opinion/2012-06-09/815179/cheaper-medicines-law-hasnt-served-poor.

Picazo, O. Review of the Cheaper Medicines Program of the Philippines. Philippine Institute for Development Studies.

World Trade Organization. (2006). TRIPS Pharmaceutical Patents Obligations and Exceptions.

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[1] According to Section 11, Article XIII of the 1987 Constitution, “The state shall adopt an integrated and comprehensive approach to health development which shall endeavour to make essential goods, health and other social services available to all people at affordable cost.” Furthermore, Section 12 of the same Article provides, “The State shall establish and maintain an effective food and drug regulatory system and undertake appropriate health, manpower development, and research, responsive to the country’s health needs and problems.”

[2]  The Bill of Rights provides, “No person shall be deprived of life, liberty, or property without due process of law, nor shall any person be denied the equal protection of the laws.”

[3] The agreement which took effect on January 1, 1995, is an international agreement on intellectual property rights which covers member countries of the WTO.

[4] William Borchard. (2012). A Trademark is not a copyright or a patent. Cowan, Liebowitz & Latman, P.c., New York.

[5] Intellectual Property Code of the Philippines [INTELLECTUAL PROPERTY CODE], R.A. 8293, Section 21.

[6]  Pearl Dean (Phil.), Incorporated v. Shoemart, Incorporated and North Edsa Marketing, Incorporated, 409 SCRA 231, August 15, 2003.

[7] The case cites Aronson v. Quick Point Pencil Co.,  440 U.S. 257, 262 [1979], citing Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470 [1994], cited Amador, patents, p, 496.

[8] Intellectual Property Code, Sec. 72.

[9]About Patents. Intellectual Property Office. Accessed on 8 October 2013, from http://www.ipophil.gov.ph/index.php/patents.

[10] Manthan, Janodia. (2008). Patents Regime in India: Issues, challenges and opportunities in Pharmaceutical Sector. Vol. 7, Issue 1, Journal of Third World Medicine.

[11] Intellectual Property Code, Sec. 93.

[12] Intellectual Property Code, Sec. 93.2.

[13] Solid Triangle v. Sheriff of RTC QC, G.R. No. 144309, November 23, 2011.

[14] Tove Gerharsen. (2006). Pfizer Fights IP Flexibilities in the Philippines. Accessed on 8 October 2013, from http://www.ip-watch.org/2006/04/30/pfizer-fights-ip-flexibilities-in-the-philippines/.

[15] World Trade Organization. (2006). TRIPS Pharmaceutical Patents Obligations and Exceptions.

[16] Id.

[17] Trade Related Aspects of Intellectual Property Rights [TRIPS], Art. 31.

[18] Manthan, Janodia. (2008). Patents Regime in India: Issues, challenges and opportunities in Pharmaceutical Sector. Vol. 7, Issue 1, Journal of Third World Medicine.

[19] Intellectual Property Office of the United Kingdom. (2013). The Research and Bolar Exception: Proposals to exempt clinical and field trials using innovative drugs from patent infringement.

[20] Id. 

[21] CMS. (2007). Bolar Provision and Regulatory Data Exclusivity in Europe. Accessed on 8 October 2013, from http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf.

[22] Gwyn Cole. Exemption from Infringement: the EU Bolar Directive. IP Europe Quarterly. Accessed on 8 October 2013, from http://www.avidity-ip.com/assets/pdf/BolarJun12.pdf.

[23] Novartis. (2011). Safe Harbor Exemption (Bolar Provision).

[24] Hogan Lovells. (2010). Spanish Supreme Court rules on Bolar and experimental research exemption. Accessed on 8 October from http://www.lexology.com/library/detail.aspx?g=20f5c6aa-fa61-47d1-b680-d632f76110ce.

[25] Id.

[26] Under Section 7 of R.A. No. 9502, “72.1. Using a patented product which has been put on the market in the Philippines by the owner of the product, or with his express consent, insofar as such use is performed after that product has been so put on the said market: Provided, That, with regard to drugs and medicines, the limitation on patent rights shall apply after a drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent owner, or  by  any  party  authorized  to  use  the  invention: Provided, further, That the right to import the drugs and medicines contemplated in this section shall be available to any government agency or any  private third party.”

[27] Oscar Picazo. Review of the Cheaper Medicines Program of the Philippines. Philippine Institute for Development Studies.

[28]  Roma Drug v. Regional Trial court of Guagua, G.R. No. 149907, April 16, 2009.

[29] The Implementing Rules of R.A. No. 9502 says, “Rule 9. Limitations on Patent Rights. The owner of a patent has no right to prevent third parties from performing, without his authorization, the acts referred to in Section 71 of the IP Code as enumerated hereunder: (i) Introduction in the Philippines or Anywhere Else in the World. Using a patented product which has been put on the market in the Philippines by the owner of the product, or with his express consent, insofar as such use is performed after that product has been so put on the said market: Provided, That, with regard to drugs and medicines, the limitation on patent rights shall apply after a drug or  medicine has been introduced in the Philippines or anywhere else in the world by the patent owner, or by any party authorized to use the invention: Provided, further, That the right to import the drugs and medicines contemplated in this section shall be available to any government agency or any private third party. (72.1) The drugs and medicines are deemed introduced when they have been sold or offered for sale anywhere else in the world. (n)”.

[30] Intellectual Property Code, Sec.7.

[31] Bengzon Negre Untalan (BNU) is a law firm focused ont he practice of intellectual property law in the Philippines.

[32] K.P. Ambrocio. (2009). The Bolar Exception: Roots and Introduction to the Philippine Patent System. Accessed on 8 October 2013 fromhttp://www.iplaw.ph/ip-views/The-Bolar-Exception-Introduction-Philippine-Patent-System.html.

[33] International Pharmaceutical Privacy Consortium, 6 March 2012.

[34] Rules and Regulations Implementing Republic Act No. 9711, Sec. 5 (ff).

[35] Data Privacy Act of 2012, R.A. No. 10173, Sec. 2.

[36] Association of Southeast Asian Nations. (2010). ASEAN Regional Guidelines on Competition Policy.

[37] Section 3.5.1.4 of the ASEAN Regional Guidelines on Competition Policy states that "Prohibitions may not apply to agreements or conduct based on specific public policy grounds."

[38] In an article by Satur Ocampo with the Philippine Star last June 9, 2012, he suggested a review in the implementation of R.A. No. 9502 because the it hasn't served the poor. The article is entitled "Cheaper medicines law hasn't served the poor" which can be accessed at http://www.philstar.com/opinion/2012-06-09/815179/cheaper-medicines-law-hasnt-served-poor.