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Philippines: Vape bill version 2022: Congress ‘hijacks’ stringent regulations

5 April 2022

By: Booma Cruz Source: VERA Files

In an apparent rush to pass the vaping bill, the 18th Congress reversed itself without regard for legislative tradition or courtesy to a lone consistently dissenting colleague.

“Traditionally, we are allowed to ask the sponsor questions during the report on the bicam… The bicameral report was read past 9 last night [Jan. 25] … It was not on the agenda and, therefore, I was not aware that it was going to be taken up,” said Sen. Pia Cayetano, who opposed the measure from the outset.

“I will not be a party to a bill that is masquerading as a health regulation,” she protested during the plenary session on Jan. 26. “It is a version that supports the [tobacco] industry and not the Filipino people.”

To proponents of the vaping bill, time was of the essence. The measure dies if both the House of Representatives and the Senate fail to reconcile and ratify the bill before the 18th Congress ends. Both chambers were scheduled to go on recess from Feb. 5 to May 22 to make way for the May 9 local and national elections.

The “Vaporized Nicotine and Non-Nicotine Products Regulation Act,” endorsed to President Rodrigo Duterte for signature, will repeal provisions of Republic Act (RA) 11467 signed in 2020. RA 11467 was an amendment to the “sin tax” law that included safeguards on the use, sale, manufacture, importation and distribution of vapes to protect public health. The mandated restrictions were due for full implementation this May.

Defined as a measure to protect and promote the people’s right to health, the bill lowers the age of access to electronic cigarettes or vapes and heated tobacco products (HTPs) from 21 to 18; takes away regulatory powers over these products from the Food and Drug Administration (FDA) and turns them over to the Department of Trade and Industry (DTI); removes the two-flavor limit on electronic juices; and permits sponsorships beyond industry associations and trade events.

As proposed by the House, the bicameral conference committee (bicam) also allowed tobacco companies to conduct corporate social responsibility (CSR)-related activities. This violates the WHO Framework Convention on Tobacco Control (FCTC), an international treaty ratified by then-president Gloria Macapagal-Arroyo in September 2003 and concurred in by the Senate in June 2005.

‘Futuristic’ application

The ratified bill covers not only the vapes and HTPs that the tobacco industry manufactures and sells today.

According to Dr. Ulysses Dorotheo, executive director of the Southeast Asia Tobacco Control Alliance (SEATCA), the pending measure covers future industry creations that fit the definition of novel tobacco products as defined in the proposal — “all non-combusted substances in solid or liquid form, and innovations, either made partly of tobacco leaf as raw material or containing nicotine from tobacco intended to be used as a substitute for cigarettes or other combusted tobacco products.”

The House contingent proposed the insertion of the phrase “and their devices, and novel tobacco products” to the Senate version of the bill, which was the agreed working draft of the conferees. The House conferees to the bicam included Reps. Wes Gatchalian, Rufus Rodriguez, Kristine Singson-Meehan, John Reynald Tiangco, Alfredo Garbin Jr., Sharon Garin, Estrellita Suansing, and Stella Quimbo. The Senate was represented by Sens. Ralph Recto, Juan Miguel Zubiri and Franklin Drilon.

Lawyer Antonio La Vina, former dean of the Ateneo de Manila School of Government, describes Congress’ flip-flop as “strange.”

“It does not make sense … Legally speaking, Congress can change the law anytime. Sometimes, they have to go back very quickly to change — typo[graphical] error, there’s something wrong … it’s not for substantive reasons,” he says.

The fast-tracked ratification of the vaping bill reminds Dr. Maricar Limpin of how the 12th Congress maneuvered the enactment of RA 9211, or the Tobacco Regulation Act of 2003. (READ: Sidebar on industry tactics)

“It’s really history repeating itself… delaying the implementation or preempting the implementation,” says Limpin, executive director of the FCTC Alliance Philippines (FCAP) and president of the Philippine College of Physicians. “It’s really undermining our legislative process because the law [RA 11467] has not yet been fully implemented, but they’re already changing it.”

Limpin recalls that the watered-down RA 9211 was rammed through the legislative mill in anticipation of the restrictive WHO-FCTC, the first evidence-based international treaty that aims to address the global tobacco epidemic.

“Around 1998, discussions on the FCTC began, so we fought for some of the provisions that were supposedly in RA 9211 … But when they saw that the FCTC would be approved, RA 9211 preempted the FCTC,” recalls Limpin, who monitored the passage of the law for FCAP and PCP.

RA 9211 was enacted by then-president Gloria Macapagal-Arroyo in June 2003, three months before the Philippines signed the WHO-FCTC and two years before the Senate ratified the treaty.

States signatory to the convention are expected to “show political commitment, not to undermine the objectives set out in it,” according to the foreword of the WHO-FCTC.

Under the Philippine Constitution, a ratified international treaty has the equal status of a national law. “Understand that there are contradictions, something in the previous law has to be harmonized… reconciled or amended,” explains La Vina.

Trade wins over health

The WHO-FCTC and the Tobacco Regulation Act have several conflicting provisions, one of which allows a tobacco industry representative to sit in the Inter-Agency Committee on Tobacco (IAC-T). Under RA 9211, the IAC-T has “the exclusive power and function to administer and implement provisions” of the law. The DTI secretary is the committee chair, while the Department of Health (DOH) secretary is vice chair.

Aside from the tobacco industry representative, other members of the committee are the secretaries of agriculture, justice, finance, environment and natural resources, science and technology, education, National Tobacco Administration administrator and nongovernment organization (NGO) representative nominated by the DOH.

The IAC-T led by DTI is seen as one of the biggest obstacles to genuine tobacco control. According to Limpin, the NGO representative to the IAC-T, health almost always loses out to trade at the committee.

Representatives of the health and education departments are the only natural allies of the NGO in the committee.

“If you look at the composition, we’d really lose … never did the DENR [Department of Environment and Natural Resources] side with us … agriculture was always represented by the National Tobacco Administration, who gets two votes. The DOF [Department of Finance], since it’s not a taxation issue, more on industry, votes for the other side … DOST [Department of Science and Technology] is very objective … DOJ [Department of Justice] always looks at it at the point of legal, the law,” explains Limpin in mixed English and Filipino.

Lawyers represent the Philippine Tobacco Institute, so an NGO representative who is not a lawyer could not win in legal discussions, she adds.

A neophyte congressman during the 12th Congress, Rep. Rozzano Rufino Biazon of Muntinlupa says the final shape of RA 9211 was proof of a very strong “pro-tobacco lobby” then led by legislators from the tobacco-producing provinces in northern Luzon.

“Back in 2001, I already felt it … The pro-tobacco lobby succeeded by the very fact that, as a regulatory body, what they did was to [create] a committee led by the DTI … In that case, the committee’s authority was diluted, especially that it was led by the DTI,” he says.

Clueless then about the art of lawmaking, Limpin recalls that she and her fellow health advocates could not understand why DTI was made chair of the committee and the DOH was not even co-chair when the bill was all about health.

“At that time, I knew nothing about the industry interference, but it was obvious to us that there was a lobby. The presence of the industry was so strong,” says Limpin. Industry representatives and congressmen “were chummy with one another,” she adds.

Delaying tactics

The late senator Juan Flavier, a former health secretary known for his “Yosi Kadiri” campaign, was the health advocates’ champion, pushing for more comprehensive and strict tobacco regulations. First elected to the Senate in 1995, he fought hard for tobacco regulation. Flavier was in his last term when the Tobacco Regulation Act was enacted in 2003.

“He wanted it to be his legacy. So, he said, ‘I cannot do anything.’ He had only one vote so he asked to compromise … because, otherwise, his term was ending and there is no law yet on tobacco control,” Limpin recalls.

Flavier knew first-hand the difficulty of enforcing tobacco control measures. His proposed bills during the 10th and 11th Congress did not prosper. The tobacco industry haled Flavier into court as health secretary for issuing Administrative Order (AO) No. 10 on the rules and regulations on labeling and advertising cigarettes. The court sided with the industry; the DOH appealed the decision.

“He wanted to have health warnings, both front and at the back of the panel because it was his AO … That was contested that time so he had it included in RA 9211 … When the court decided, [it] was supposedly for implementation in 2003, RA 9211 was already enacted, so the implementation was pushed back again,” says Limpin.

Although the industry no longer disputes that smoking kills, it has not stopped challenging efforts to implement the WHO-FCTC, and RA 9211 has been the anchor of its cases in court. Even the IAC-T, where the tobacco industry is represented, was not spared by litigious tobacco firms.

“A day prior to the implementation of the law on total ban on outdoor advertising, the inter-agency committee was sued … so the law could not be implemented … Individual companies [filed the case], not the Philippine Tobacco Institute … so they won’t look stupid,” says Limpin, an IAC-T member as NGO representative.

Fortune Tobacco Corp. filed the case in Marikina City, the company’s home base. The Marikina court ruled in favor of the industry, defining point-of-sale premises to include the entire tract of land where the store is located. This meant that tobacco advertising materials could not be limited to the interior walls of stores, contrary to the IAC-T’s interpretation of the tobacco control law.

Prestigious law firms always represented the tobacco industry, while overworked and underpaid lawyers of the Office of the Solicitor General handled the government’s cases.

In May 2010, the DOH issued AO No. 13 to implement Article 11 of the WHO-FCTC, which requires tobacco companies to place pictorial warnings instead of mere textual caution on the products’ health effects. The move was way past the September 2008 deadline for compliance to the treaty.

Five major tobacco firms — Fortune Tobacco, Mighty Corp., Philip Morris Fortune Tobacco Corp., Japan Tobacco International, and Telengtan Brothers & Sons (La Suerte Cigar) — filed separate lawsuits in their principal places of business to stop the AO implementation.

The tobacco firms argued that Article 11 could be implemented only by enacting an enabling national law. Their justification: RA 9211 explicitly said “no other printed warnings, except the health warning and message required [‘NOT FOR SALE TO MINORS’] shall be placed on cigarette packages.” The courts ruled in favor of the tobacco firms; the DOH appealed the decision to the Supreme Court.

The DOH petition became moot with the passage of RA 10643, or the Graphic Health Warnings on Tobacco Products, in July 2014. By then, the implementation of AO 13 had already been delayed for three years.

FDA and the tobacco lobby

In 2012, the tobacco industry scored a major legal victory. It succeeded in blocking the authority of FDA over tobacco products and the tobacco industry. The Las Pinas Regional Trial Court ruled that the IAC-T has exclusive authority to regulate tobacco products under RA 9211 and putting these under FDA supervision would encroach on IAC-T’s jurisdiction.

The FDA raised the issue to the Supreme Court; the case is still pending.

The agency published new implementing rules and regulations (IRR).

Addressing colleagues pushing for DTI or IAC-T jurisdiction over novel tobacco products “just like cigarettes” during the September 2021 interpellation on the vape bill, Cayetano noted that RA 9711, or the FDA Act, was supposed to cover cigarettes.

“If his honor is using that as basis, I’m letting the public know, I’m letting our colleagues know that [the reason] it is not under the FDA now is a product of the cigarette company lobby… the industry lobbied against the jurisdiction of the FDA,” Cayetano told Senate President Pro Tempore Ralph Recto, the main proponent of the vape bill.

Under RA 9711, the FDA is designated as the lead regulatory agency on health products in the country. It is mandated to “ensure the safety, efficacy or quality of health products which include food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-emitting devices or equipment, and household/urban hazardous substances, including pesticides and toys, or consumer products that may have an effect on health which require regulations as determined by the FDA.”

The FDA was given the regulatory powers over vapes and heated tobacco products (HTPs) during the first regular session of the 18th Congress when it passed RA 11467, which was signed by Duterte in January 2020. Cayetano sponsored the measure.

Legalizing vapes and HTPs through taxation

According to Dorotheo, RA 11467 was a compromise bill to ensure an increase in cigarette taxes. He says the finance and health departments were pushing only for higher taxes on cigarettes, but at the last minute, Recto inserted a provision taxing e-cigarettes and HTPs at rates much lower than cigarettes. The rationale: these products are “95% less harmful” than cigarettes, a claim disputed by health authorities. (READ: Sidebar on harm reduction)

Biazon believes HTPs, which use tobacco, must be under RA 9211 and should have been levied higher taxes like cigarettes. But it was lumped together with vapes as alternatives to tobacco use.

“That was a hostage type of tactic because if that is not approved, the higher tax rate for cigarettes may not be approved. So the DOF and DOH said, ‘we will concede … we will accept [it] so that we can get the higher rates for cigarettes’,” says Dorotheo. “By having them taxed, they (e-cigarettes and HTPs) have become legitimate. They can’t be banned.”

The same tactic was said to have been applied in other countries like Indonesia, which did not have any regulation on novel tobacco products until the finance ministry decided to impose taxes that legalized the “sin” product.

Upon the request of legislators, the tobacco industry was given 18 months from the issuance of the IRR to comply with the requirements of RA 11467. Among those that remained unimplemented were the contentious provisions such as the FDA jurisdiction over vapes and HTPs, the 21-year-old minimum age of access, and the two-flavor limit on electronic juice.

Duterte: Vapes and HTPs are toxic

Two months before signing RA 11467 in 2020, Duterte, a known anti-smoking advocate, announced that he would ban vapes and HTPs because these are “toxic.” (READ: Sidebar on flavors)

Less than two weeks before the president’s anti-vape pronouncements, the FDA announced the temporary suspension of the implementation of AO 7, the revised rules and regulations on vapes and HTPs, to comply with an injunction issued by the Pasig Regional Trial Court following a petition by a vape seller. AO 7 was issued to support Executive Order (EO) 26, signed by Duterte in 2017, which imposed a nationwide ban on cigarette and tobacco smoking in public, by including vaping and using HTPs.

But in February 2020, Duterte made good on his word and issued EO 106, ordering the ban on the manufacture, distribution, marketing, and sale of unregistered e-cigarettes and HTPs and their use in public places. In his letter to the Senate president and the speaker of the House, Duterte “instructed the FDA to formulate the intended regulatory framework and relevant agencies to immediately operationalize” EO 106.

Health advocates considered RA 11467 a victory against the tobacco industry, but the exultation was short-lived. When the second regular session of the 18th Congress opened in July 2020, vape bills, mostly amending the still unimplemented provisions of RA 11467, were prioritized for legislation. Most of the proposed amendments were on regulation, following the pattern of RA 9211 and giving DTI jurisdiction, among others. (READ: Sidebar on regulation)

Former FDA director-general Eric Domingo expected the move.

“We knew that [the regulatory provisions] would be targeted because even while [RA] 11467 was being deliberated on, some congressmen and senators were already asking – why the age limit was so high, why flavors are restricted … Even with the law that was passed, we knew that it would still be the provisions that we should protect,” says Domingo. “Exactly when the transition period was about to expire, they came up with this new proposed law and we knew that they had planned it.”

Superiority in number vs scientific data

There is no shortage of tobacco industry supporters in the House of Representatives. In May 2018, the 17th Congress adopted House Resolution 1885, urging the DOH to promote harm reduction measures as part of its national tobacco control strategy, particularly the use of e-cigarettes as an alternative for smokers.

The legislative proceedings that shaped the House vape bill left no doubt whose side a majority of the lawmakers of the 18th Congress were on.

Invited as an expert panelist to the hearings, Dr. Rizalina Gonzalez, chairperson of the Philippine Pediatric Society – Tobacco Control Advocacy Group, remembers some legislators outrightly dismissing studies that do not support their position.

One lawmaker supposedly told her: “You don’t know what you are saying, Doctor.” Another said pointblank: “I won’t believe that.”

According to Dorotheo, a party-list representative berated the FDA for saying “nicotine is poison.”

“Don’t tell me it’s poison; otherwise, I’m not going to listen to you,” he quotes the lawmaker as saying.

He adds: “That’s technically correct. If you open up a pharmacology textbook, nicotine is really classified as a poison.”

Involved in tobacco control advocacy for decades, Dorotheo says, “We’ve never had congressmen speak like that before.”

Gonzalez observed that legislators, on the other hand, were more open and gracious with experts representing the tobacco industry.

She recalls that even when she and Dorotheo would arrive early, “we were positioned in the far end and all those with the industry were beside the legislators … they kept saying, ‘we have visitors here and let’s listen to them, they all came from Singapore’.”

Despite the cold, if not hostile, treatment toward health advocates in the House, Domingo still could not wrap his head around the fact that Congress reversed itself within 18 months, without even implementing the previously approved provisions.

“It’s exactly the same House, same Senate … it was passed. We showed them the same data, and even updated the data, but this time we lost … We didn’t come from just anywhere. We thoroughly studied these, we asked the experts … It’s difficult to understand how it happened,” says the former FDA head.

Aside from documents presented by the DOH and FDA, the World Health Organization submitted numerous data and registered very strong positions against vaping.

“The only people who would gain from this are from the tobacco industry,” says Domingo.

Health advocates lost the battle because they did not have the numbers in Congress.

“It’s really critical to have the numbers. That’s what an interest group would work on. We know from history that the practice of the tobacco industry is to really aggressively get people on their side, and the outcome turned out that many were on the side of regulation by DTI. That’s what happened. At the level of the committee, initially, that’s where they need the numbers,” explains Biazon.

Unseen hands behind the bills

The vape bills were initially referred to the committee on health headed by Rep. Angelina “Helen” Tan of Quezon province. As proposals pushing for DTI jurisdiction over vapes were filed, the bills were referred jointly to include the committee on trade. When the measure was passed on to the technical working group (TWG), the committee on trade took the initiative.

Health advocates consider Tan as an ally. They, however, observed Tan’s “unusual less aggressive” demeanor during the hearings.

Ralph Degollacion, project manager of public health think tank Health Justice Philippines, says Tan must have been under pressure from a senior and more powerful member of the House. “It is an open secret in the House of Representatives that when it comes to tobacco-related bills, the Northern Luzon Alliance is in charge of it,” he says.

VERA Files tried to reach Tan to get her side of the story, but nothing has been heard from her end as of press time. The legislator is running for governor in Quezon Province.

Most of the discussions and work on the House vape bill were done in the TWG, where legislators actively participated. In other instances, TWGs are composed of mostly technical legislative staff tasked to consolidate bills discussed in the committee where the debates take place.

Unlike in committee hearings, TWG proceedings are not documented and this helped in shaping the vape bill.

“Some legislators are more brazen to make statements or decisions that might be unpopular or might show that his/her agenda is really disadvantageous to stakeholders … That’s what happened … and they had the numbers,” says Biazon.

When it was pointed out that the FDA should be the agency to regulate novel tobacco products because the claim “vapes and HTPs are safer alternatives to smoking” is related to health, proponents supposedly made the short cut. “They changed the definition. They removed the term from the law making it appear that it’s health-related,” the lawmaker from Muntinlupa says.

Based on accounts of those who attended the hearings, vape bill proponents were all out in support of industry representatives, chiming in their agreement to points raised. Some party-list representatives were not to be outdone. They gave the issue a pro-health spin — give an option to smokers who want to quit.

But some legislators went over the top, reading the arguments and position papers of the tobacco industry to explain their stance.

At the height of the hearings, pictures of legislators attending a conference in the United Kingdom and dining with lawyers of Philip Morris were seen posted on social media. Some of those who joined the London trip were authors of vape bills. Among the arguments used by vape proponents were based on studies done in the UK.

Horse-trading

A research on the conduct of the tobacco industry in the Philippines since the 1960s noted the country’s reputation for endemic political corruption. Quoting a 1962 Philip Morris document, the study said, “key political figures might be paid off in order to release tobacco being withheld from sale.”

Asked if the vape bill was a product of horse-trading, Biazon says he can only speculate that there was horse-trading. “But I don’t have anything at hand to substantiate. It’s just the… the way I know how the system is and what’s the weaknesses and opportunities, so I would say yeah, it’s possible that it happened,” he adds.

Biazon also admits he does not have solid evidence of tobacco industry interference but “I could feel that there was an active involvement of a lobby now that I know the system.”

There was tremendous pressure to pass a vape bill that would weaken the health safeguards in RA 11467 before its full implementation in May.

“[The attacks] did not stop. Every time the Department of Health or FDA does anything to try to regulate such products, there is always very strong resistance,” says Domingo (READ: Sidebar on Emasculating the FDA)

Questioning FDA’s credibility

The FDA was savagely attacked at the height of the vape bill hearings for receiving a $150,430 (roughly equivalent to P7.5 million) grant from Bloomberg Philanthropies and The International Union Against Tuberculosis and Lung Disease (The Union) to enhance the agency’s regulatory capacity. The project duration was from February 2017 to June 2020.

Bloomberg Philanthropies and The Union are non-profit organizations actively involved in the fight against tobacco use worldwide.

Legislators claimed that the grant from these organizations was tantamount to “foreign interference,” which “undermined” the country’s sovereignty. The FDA allegedly violated three laws for accepting the grant: the Code of Conduct and Ethical Standards for Public Officials and Employees (Section 70, RA 6713); Foreign Agents Act (Section 11, Batas Pambansa Blg. 39); and the Anti-Graft and Corrupt Practices Act (Section 3[e], RA 3019).

Deputy Speaker Deogracias Savellano of Ilocos Sur, the acknowledged de facto head of the pro-tobacco Northern Luzon Alliance, and Rep. Estrellita Suansing of Nueva Ecija asked the House committee on good government to investigate the “questionable receipt of private funding by the FDA.”

Grilled during the inquiry, FDA officials cited RA 9711 which allows the agency to accept grants, donations, and all other endowments from local as well as external sources as long as pertinent rules and regulations are followed. The funds, used to hire additional personnel, buy reagents and set up an information technology system, were fully audited, and the unutilized amount of P1.6 million returned to the funder.

“They were saying there was conflict of interest, but the Civil Service has rules on which grants are allowed and FDA, for its part, I looked at the documents, followed everything, and [made sure] there was no conflict of interest,” says Domingo.

The agency and the DOH have always been working with partners with very similar goals, the former FDA head points out. Because there is nothing healthy with tobacco use, Domingo says it is a “natural enemy” insofar as health is concerned.

The legislators demand a balanced policy in addressing the concerns of the tobacco industry and public health. Various arguments have been posited to protect the industry — to increase taxes, generate jobs, defend human rights or freedom of choice, support the arts and sports, allow corporate social responsibility to help those in need, among others.

But to Domingo, the choice is clear: “When it comes to public health, public health should always be paramount, should always be above anything else.”

Up to now, Rodley Carza, chief of the DOH Policy and Technology Division, could not forget how FDA officials were skewered during the House hearings. “It’s still fresh in my mind. It is apparent that the representatives from the executive branch are being intimidated. [I] can see really that [the legislators] were not listening,” recalls the agency’s focal point on tobacco control.

“We can’t say what’s their motivation behind this, but we keep echoing that the bill is really contradicting the intended goal of the supposed legislation,” says Carza.

“I felt that while we were pushing for the FDA, the FDA was placed under attack to put its credibility on the line. They were beaten hard. So for a while, [FDA] would not issue the IRR, to proceed with the IRR because their authority is being questioned,” says Biazon.

Legal maneuver vs tobacco control

Domingo believes the attack on the FDA was a legal maneuver to discourage and prevent people with similar interests to work together for a common cause. He says the strategy is being tried in other countries as well.

During the committee on good government inquiry, lawmakers questioned the legitimacy of the Joint Memorandum Circular (JMC) 2010-01 on the Protection of the Bureaucracy Against Tobacco Industry Interference, citing its “procedural infirmities.”

Issued by the DOH and Civil Service Commission in June 2010, the JMC is an implementation of the WHO-FCTC provision which prohibits “unnecessary interaction” with the tobacco industry. The memorandum, signed by then-CSC chair Francisco Duque III and Health secretary Esperanza Cabral, covers all government officials and employees, legislators included, regardless of status.

Lawmakers argued that the CSC is a collegial body and Duque did not have the right to sign on behalf of the entire board without any authorization. The procedural lapse rendered the JMC void ab initio (from the beginning), they claimed.

But, according to La Vina, Congress cannot declare an act of the executive void or legal. A ruling to overturn it has to be done by the judiciary.

Moreover, the CSC chair can sign for the whole commission because the assumption is that he had the go-signal of the board, La Vina explains. “You do not have joint memorandums between two agencies where you have all the commissioners that are signing, isn’t it?” he adds.

Now headed by Duque, the DOH was lambasted during the hearings on the FDA grant for refusing to accept 30 respirators donated by a private foundation associated with the tobacco industry in the midst of the Covid-19 pandemic because of the JMC. Rep. Rufus Rodriguez of Cagayan de Oro called the DOH decision “criminal negligence.”

The health department reported that it facilitated the immediate delivery of the machines in mid- 2021 to 10 private hospitals identified by the donor for use of Covid-19 patients.

Organizations associated with the tobacco industry have been giving donations left and right to government agencies and jurisdictions of politicians in violation of the JMC and the WHO-FCTC.

The endorsed vaping bill allows tobacco industry CSR-related activities, which would effectively destroy the firewall that the JMC and the WHO-FCTC have been trying to build between the bureaucracy and the tobacco industry.

For Carza, the attempt to revise or repeal the JMC is a clear indication of tobacco industry interference.

“Over the past years, we see the tobacco industry interference ramping up, that we experience and that’s very alarming for us. We see the evidence. There’s actually a House resolution declaring it, or arguing, that it is actually unconstitutional,” he says. “There are no court rulings or any decision that really nullifies the said policy. We still remain committed to protecting the bureaucracy from tobacco industry interference.”

Curiously, a draft report of the committee on good government and public accountability on the FDA grant inquiry was uploaded on a US-based website and a local media agency’s portal at least two months before it was submitted to the Speaker and copies sent to concerned agencies.

Buzzer-beater

House Bill (HB) 9007, the Non-Combustible Nicotine Delivery Systems Regulation Act, passed on second reading on May 19, 2021, and on third reading a week later with 192 yes and 34 no votes with four abstentions.

The approval of the bill, a consolidation of 23 measures co-authored by 154 representatives, was a buzzer-beater, passing barely eight days before the sine die adjournment of the second regular session of the 18th Congress.

The House vape bill was then referred to the Senate committee on trade headed by Sen. Aquilino Pimentel III.

Recto, who chaired a subcommittee under the trade panel, wasted no time and conducted hearings on his vape bill, which had a lot in common with HB 9007 — removing regulatory powers from FDA and transferring it to DTI, lowering the age of access from 21 to 18 years old, allowing multiple e-juice flavors and internet advertising, among others.

What happened to the proposed vape measures in the House was repeated in the Senate. Those filed with the committee on health under Sen. Christopher Lawrence “Bong” Go ended up in the committee of trade.

A surprised Cayetano questioned the transfer. An outspoken vape defender, Recto responded that the transfer was a decision of the plenary, and, according to Zubiri, Go did not object. Go was a former special assistant to President Duterte, who is known to be against smoking and vaping.

“With just one hearing, Sen. Recto’s sub-committee came out with his consolidated bill for second reading,” recalls Dorotheo, who had been closely monitoring congressional hearings on tobacco control for decades.

Hailing from the province of Batangas, where the $300-million Philip Morris plant is located, Recto is the sponsor of SB 2239, the counterpart measure of HB 9007 in the Senate.

During the interpellation on SB 2239, which was live-streamed through Facebook online, Recto insisted that vapes were less harmful and, therefore, a good alternative to tobacco products. He claimed to have felt much better since shifting to vapes. When asked by Go why he has not kicked the habit, the senator said, ‘soon,’ adding that quitting is a work in progress.

According to Recto, the DTI is in the best position to regulate vapes and HTPs because these are “consumer” products — an “electronic product,” “not medicine.” Sen. Imee Marcos, of the tobacco-producing province of Ilocos Norte, said novel tobacco products do not have pharmaceutical claims and should, therefore, be under the DTI.

Recto also pointed to the inquiry conducted by the House which claimed that the FDA is biased, and asserted that the DTI is not.

Insisting that vapes are consumer products and the DTI has the capacity and capability to regulate these novel tobacco products, Recto said during the Dec. 6, 2021 plenary session, “from my understanding they [DTI] already bought the equipment to be able to regulate these products safely.”

Cayetano was surprised with the revelation. “Is his honor saying that even though we don’t have a law that allows DTI they would be making such kind of investments … I will question those … I will look into those purchases because that is not allowed. They have no authority under the existing law … unless they have been assured by the tobacco lobby or whoever that this law would be overturned,” she said.

Recto replied: “I am only stating a fact. I did not make this purchase for the DTI. The DTI has the equipment. Prior to the sin tax law, my understanding was that this product was already regulated by the DTI.”

Vapes and HTPs were not regulated by the DTI prior to the sin tax law. The regulation of these products was under the FDA, based on the FDA law and the Consumer Act. In 2014, the DOH through AO 8 classified vapes as pharmaceutical products to be regulated by the FDA. The implementing rules and regulations on the manufacture and sale of e-cigarettes issued by the DOH in 2019 gave manufacturers, sellers, distributors, and exporters until October 2019 to comply and register with the FDA. But the FDA announced a temporary suspension of the implementation of AO 7 on Nov. 7, 2019, because of a preliminary injunction issued by the Pasig City regional trial court.

During the Senate hearings on the sin tax law in 2019, Sen. Francis Tolentino “lamented that the country still has no regulations on the products as the bills aimed at strengthening and empowering the FDA and for the FDA to take notice of the regulations of other countries, are still pending in Congress.”

‘Children’ of the cigarette industry

Cayetano rebutted Recto’s defense point-by-point, saying the provisions that her colleague was pushing for were making members of the chamber “susceptible” to the tobacco lobby. She called novel tobacco products as children of the cigarette industry and the new frontier of tobacco interference.

“There’s nothing wrong per se with the industry that is legitimately recognized in the Philippines to make their positions known. We talk to them, but I feel that it’s a sad reality that we expose ourselves to that kind of pressure when we already settled this by law.

“By reopening it, it is just providing a venue for a very strong industry to lobby with our colleagues and I regret that we put ourselves in that kind of position because we already made a decision and that decision is currently law … These are political decisions that we make because these are strong lobby groups … We are not even in a different Congress. We’re the same members of Congress beginning to discuss these points when we could be discussing other issues,” said Cayetano, chair of the ways and means committee.

Cayetano and Recto were always at loggerheads during the interpellations that, at one point, Senate President Vicente “Tito” Sotto III commented that the debate on whether DTI or FDA should have jurisdiction over vapes was going on for over an hour without reaching a consensus. Zubiri moved to put the proposed provision to a vote so the chamber could proceed to the amendments.

Five proposed amendments were eventually put to a vote:

1) On Declaration of Policy — to use internationally accepted product and health standards in regulating vapes and HTPs

2) On the definition of vaporized nicotine and non-nicotine products — to retain the difference between vapes and HTPs. Vapes are vapor products while HTPs are tobacco products.

3) On minimum age of access — to retain minimum age of access at 21 years old

4) On product registration — to place registration under the FDA and DTI

5) On exclusive jurisdiction with the DTI to regulate these products — to retain concurrent jurisdiction of the FDA (on safety of the devices) and the DTI.

Votes weaken regulations

Only Cayetano and Go voted for all the proposed amendments to SB 2239. But during the final vote on the measure, Go abstained and Cayetano became the lone consistent anti-vape champion.

The Senate vape bill was passed on 3rd and final reading with 19 yes and 2 no votes with 2 abstentions. [READ: Sidebar on how they voted]

“Senate Bill 2239 reverses the protective measures that we as a Congress, that we as a Senate, put in. Why would we reverse it?,” Cayetano asked. “During the deliberation of the sin tax bill around two years ago … everyone accepted, from my recollection, that they are a sin product. They are harmful products. There was no discussion on that. In fact, the question was how harmful they are,”she recalled.

“We are now reinventing the rules of our government agencies … What business does the Department of Trade and Industry have to regulate health?” Cayetano asked again after her colleagues in the Senate voted to approve the vape bill.

A review of the Senate journal shows that SB 1074 was approved on third reading during the first regular session of the 18th Congress with 20 “yes” votes and no objections. The bill imposed taxes on liquor, vapes and HTPs and included regulatory provisions, which the chamber now amended through SB 2239.

Sen. Emmanuel Pacquiao moved to have vapes and HTPs under the regulatory provision of the FDA. But, according to Zubiri, Recto objected because HTPs are tobacco products and, as such, should be regulated by the IAC-T. Sotto clarified that Recto was only pointing out the redundancy, given the existing Tobacco Regulation Act.

“Senator Recto manifested that the reason he wanted the Department of Trade and Industry to get involved is that it must be the lead agency insofar as the safety issue of the gadgets is concerned,” read the journal.

The Pacquiao amendment won with 10 “yes” and 9 “no” votes with one abstention. Explaining his vote, Sotto said he voted “yes” even if he was not in favor of the proposal because he wanted to show support for Cayetano.

Initially approved was the proposal of Tolentino, setting the minimum age of access at 25 years old, but Zubiri moved to reconsider the approval and the body eventually voted to lower it to 21 years old. (READ: Sidebar on age)

Throughout the deliberations, Recto was all-out in pushing for novel tobacco products as a less harmful alternative to regular, conventional cigarettes. Zubiri and Sotto agreed with him.

On the other hand, Tolentino wanted a ban on vapes and HTPs until health claims are scientifically proven. He cited the WHO circular that the novel tobacco products could not be safely recommended for consumption because of unknown factors associated with their use.

Vapes and HTPs have the potential to undermine existing tobacco control measures, said Tolentino, who served as chair of the Metro Manila Development Authority (MMDA) from 2010 to 2015.

As MMDA chair, he launched an anti-smoking campaign that ordered the arrest of persons caught smoking in public places along major and secondary roads in the metropolis and places not listed in RA 9211. The MMDA was a recipient of a $180,000 grant from Bloomberg Philanthropies for its anti-smoking campaign.

In 2011, the Mandaluyong Regional Trial Court issued a preliminary injunction against the agency’s anti-smoking drive following the arrest of violators. The case was elevated to the Court of Appeals, which decided against the MMDA four years later.

‘Political environment’ bars FCTC implementation

The numerous court cases over the years, resulting from the conflicting provisions of RA 9211 and the WHO-FCTC, could have been avoided and managed through policy and legislative as well as scientific work, says Carza.

In one of the decisions in favor of the tobacco industry, the court said the WHO-FCTC is not self-executing. Until laws are passed or amended to harmonize the conflicting provisions of the international treaty and the existing domestic law, the court has no choice but to uphold the prevailing RA 9211.

In its periodic reports to the Conference of Parties, the governing body of the WHO-FCTC, the Philippine government has always identified “political environment” as the constraint or barrier in implementing the convention.

Carza thinks the most difficult provision to implement in the WHO-FCTC pertains to the guidelines against tobacco industry interference.

“Tobacco industry interference will take a lot of political will. Adherence to a certain principle is really out of the control of the agency,” he says.

Although they have lost the battle in Congress, health advocates are not ready to throw in the towel. Limpin says the FCAP will file a case in the Supreme Court to question the constitutionality of the measure if Duterte walks his remarks back and signs the vape bill.

“At the very least I cannot give up on the FDA. I don’t think it has to be DTI. That (filing a case) is my intention, my plan. That has been approved already by the board,” she says.

A matter of life and death

For Domingo, the vape bill has to be stopped because it involves a matter of life and death.

“We didn’t know the harmful effects of cigarettes; we took it for granted. The industry grew bigger until we’ve realized that half of the population is dying because of it. So, it’s too late already.

“It’s like, we foresee 40 years from now, these [vapes and HTPs] will be the ones killing everybody or getting everybody hooked into smoking and getting a lot of problems,” says Domingo.

History validates the former FDA director’s concerns. Tobacco companies had known for decades about the dangers of smoking but conspired to hide it from the public. Millions have died due to smoking-related diseases since the 1950s, when concerns about the safety of tobacco products were raised.

Files from court cases in the US and released to the public in 1998 under a Master Settlement Agreement between the state of Minnesota and five Big Tobacco firms also showed that the industry targeted children.

In a landmark decision in 2006, US District Judge Gladys Kessler said there was “overwhelming evidence” that tobacco firms “marketed and sold their lethal products with zeal, with deception, with single-minded focus on their financial success, and without regard for the human tragedy or social costs that success extracted.”

According to the DOH, 87,600 Filipinos die from tobacco-related diseases every year, while total healthcare expenses amount to P180 billion annually.

Domingo warns that giving the industry the benefit of the doubt on vapes and HTPs could be disastrous.

There have been a few cases of acute lung injuries linked to the use of novel tobacco products. He says it would take some time before the long-term effects of vapes and HTPs on health could be definitely established.

“Now is such a good time for us to start controlling it and regulating it and finding out more about it before we let everybody have access to it. If we don’t pay attention to it, after 40 years, we will remember that in 2020, we had that opportunity. There was a law regulating this but we overturned it with another law and this is what happened 30 years later. That is really sad,” says Domingo.

*VERA Files reached out to PMFTC, Inc., the Philippine affiliate of Philip Morris International, for its side of the story. The company, which controls over 90% of the local market, declined our requests for an interview and a comment to a set of questions “until [the vape bill is] officially acted upon by the Palace.

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