‘Risk-proportionate' regulatory regime

January 06, 2020

Ignorance is the new excellence. The less you know the more seemingly you gain. Not to care is deemed to be smart. -                           -- Widows

The New Year rings in fresh challenges as well as opportunities.

But quite disturbingly, some old, pesky problems remain unresolved with the turning of the calendar because we refuse to even begin considering how to approach and wrestle them down.

Trade and Industry Sec. Ramon M. Lopez recently unveiled the Securing Manufacturing Revitalization and Transformation Program to business leaders and manufacturers present at the Manufacturing Summit.

Speaking at the event, Lopez supported the program’s objectives of revitalizing the manufacturing sector to continue its high growth trajectory and help transition the industries to Industry 4.0.

The SMART program fully supports the new flagship industrial strategy of the government as it is consistent with the Philippine Development Plan, the i3S (Inclusive Innovation Industrial Strategy), and the inclusive Filipinnovation & Entrepreneurship Roadmap.

Among the program’s priorities are “emerging industries”.

So how do we tread the path to a safer, less harmful l way of life this year?

For starters, by revisiting a regulatory regime that offer no escape clauses or “wiggle room” for emerging industries to spawn, survive, and thrive.

Calibrated, measured, proportionate industrial regulation is the way to go this year.

A risk-proportionate and realistic regulatory framework would help maximize the use of electronic cigarettes as an effective harm-reduction and smoking-cessation strategy for the promotion of public health.

This was the key message of Dr. Konstantinos E. Farsalinos in his testimony before the Joint Trade and Health Committee of the House of Representatives last month. The committee is tackling several bills that seek to regulate the manufacture, importation, packaging, use, sale, distribution, and advertisement of e-cigarettes and heated tobacco products.

“The best example of a comprehensive and fully implemented regulatory framework on e-cigarettes is the Tobacco Products Directive of the European Union,” explained Farsalinos, an adjunct professor at the King Abdulaziz University; and Researcher at Onassis Cardiac Surgery Center, University of Patras, and National School of Public Health, all in Greece.

The TPD was promulgated in 2014 and adopted into the national legislation of all European Union-member states in 2016. It regulates e-cigarettes under a separate section that does not classify them as tobacco products.

“This is appropriate because e-cigarettes do not contain any tobacco. All e-cigarette products in the EU are marketed as consumer products with limited restrictions. The Philippines has an opportunity to use the TPD as a guide in creating an e-cigarette regulatory framework that will maximize public health benefits and minimize potential risks,” stressed Farsalinos as he urged local legislators to consider several principles in creating an appropriate e-cigarette regulatory framework.

According to Farsalinos, regulation for e-cigs should be risk-proportionate. “This is the only proper approach to the regulation of any product. Evidence on risk determines the levels of restrictions that need to be implemented. There is compelling and undisputed evidence on the very low risk of e-cigarettes, especially when compared with the devastating effects of smoking.”

E-cig regulation should be realistic and ensure product quality, said Farsalinos.

“It would make little sense to create a regulation that would be expensive or difficult to comply. This would result in the elimination of electronic cigarettes and the creation of an uncontrolled black market. Both consequences will end-up protecting tobacco cigarette sales while no quality standards can be expected from black market products.”

He stressed the importance of regulations to ensure that e-cigs do not target never-smokers and youth.

“Selling of e-cigarettes to people below 18 years old should be banned, with heavy fines imposed on violators. There should be specific regulatory restrictions—not a ban—on e-cigarette advertising and marketing and proper education that e-cigarettes should be used as smoking substitutes only.”

According to Farsalinos, regulation should create a competitive advantage for e-cigs over tobacco cigarettes.

“Unfortunately, tobacco cigarettes are very cheap to make and generate a lot of profits for the industry. On the other hand, e-cigarettes are technology products; thus, they are, by definition, more expensive to produce than tobacco products.” He called on legislators to create regulation that would motivate smokers to switch to e-cigarettes and completely quit smoking. “E-cigarettes should be taxed lower than tobacco cigarettes.”

The Greek academic stressed that regulation should classify e-cigs as consumer products with specific rules and restrictions.

“The success of e-cigarettes as smoking substitutes is based on their use as consumer products.” He recommended regulation that allows innovation and development of better and even safer e-cigarette products. “Being technology products, e-cigarettes have evolved at a rapid pace in recent years. Currently, available products are safer and more effective as smoking substitutes than the products available a few years ago because of the use of better materials.” Such innovations provide a better experience for smokers and a more effective way of alleviating smoking cravings, he added.

“I encourage the Philippines to follow the lead of other countries that have looked at the evidence with an open mind and made decisions that will eventually eliminate smoking,” Farsalinos said.

He cited how the UK’s National Institute of Clinical Excellence actively recommends that healthcare workers advise smokers about the potential of e-cigs as smoking cessation aids, while the UK Parliament Science and Technology Committee recommended an even more liberal regulatory framework for e-cigarettes to further strengthen their effectiveness as a smoking cessation measure.  

“Vape shops are now opening in public hospitals in the UK. All these indicate the acceptability of evidence of safety and efficacy of these products and the valuable prospects of strengthening the tobacco control measures through a harm reduction strategy with electronic cigarettes. Canada, New Zealand, and Switzerland are also following a similar path,” he said.

Behold God’s glory and seek His mery.

Pause and pray, people