An evening with Dengvaxia makers in Paris

Gigi Grande, ABS-CBN News

Posted at Dec 07 2017 10:22 AM | Updated as of Dec 08 2017 07:34 AM

Health Secretary Janette Garin. File Photo

(UPDATED) PARIS, it is said, is most beautiful in the springtime.

In the spring of 2015, Health Secretary Janette Garin was there, not to see the sights, but to meet and dine with important people, including top honchos of Sanofi-Pasteur, the maker of the now controversial anti-dengue vaccine aptly called Dengvaxia.

Garin had confirmed setting foot in Paris in May 2015, but denied she ever dined with Sanofi-Pasteur officials. She only met with the French Health Minister, she told ABS-CBN News in an interview in May 2017.

Dispatch to DFA

But the night seemed to have a thousand eyes.

A May 2015 report dispatched by the Philippine Ambassador to France to the Department of Foreign Affairs (DFA) detailed what Garin did in Paris in 2015.

ABS-CBN News has obtained a copy of the report duly signed by Ambassador to France Theresa P. Lazaro.

Sanofi's who's who

Lazaro’s report provided details of Garin’s various official engagements in France that month, including a dinner in Paris on May 14, 2015 between Garin and Guillaume Leroy, Vice President of Sanofi-Pasteur’s Dengue Vaccine Program.

With Garin and Leroy during the dinner were Jean-Antoine Zinsou, Sanofi-Pasteur’s Senior Director for Vaccination Policy and Advocacy, and Ching Santos, the company’s Country Manager in the Philippines, according to the report.

Pricing, strategy

Garin and Sanofi-Pasteur officials discussed, among others, the price of the vaccine, how to create a demand for it in the Philippines, and a strategy to justify its inclusion in the succeeding Philippine budget.

“Secretary Garin inquired on the prices of the vaccine,” read a portion of the report. “She stated that it may be too expensive for the Philippine government to fully cover the cost of the 3-dose vaccine.”

To which, Leroy was said to have replied: “…Sanofi-Pasteur will finalize a proposal (cost/pricing) for the Philippines by June 2015.”

Private sector

According to the report, Garin also suggested that the “private sector launch the vaccine” in the Philippines.

“A private launch and widespread ‘private use’ will create a demand for the vaccine, and will thus pave the way for the Department of Health (DOH) to include (it) in the succeeding years’ budget,” the report said, quoting Garin.

The following day, the report said, Sanofi-Pasteur officials gave Garin and her delegation a tour of the Neuville Dengue Facility in Lyon, Eastern France.

Garin confirmed the tour took place, but said it had nothing to do with the dengue vaccine.

Who funded the trip?

She said the Delegation of the European Union to the Philippines had funded the trip as part of the World Health Assembly.

The plant visit was a side trip, she said, because the Philippines had inquired about manufacturing vaccines locally.
“Ang punto nila is, if you want technical expertise on vaccine manufacturing, hindi lang technical expertise ang kulang nyo kundi lugar,” she said.

Garin’s denial

Garin categorically told ABS-CBN News that no meeting with Sanofi-Pasteur officials took place in Paris. “The meeting in Paris was with the Health Minister,” she said in a May 2017 interview.

It wasn’t clear if Garin knew of the report received by the DFA, or was aware that embassy officials make routine reports to the home office regarding the activities of all visiting government officials.

ABS-CBN News sought Garin’s comment about the meeting anew, but she has not yet responded. Her father, Jose Loreto, passed away on Tuesday, December 5.

Clandestine visit?

The DFA would not have known about Garin’s visit to France in May 2015 had they not been alerted by the French Foreign Ministry. This is unusual, as the DFA is in the loop about ministerial-level delegations so that substantive and administrative preparations could be made.

“Based on personal discussions with (France’s) Ambassador Garachon, it appears that they too had no full knowledge of the Secretary’s program and agenda in France,” the report stated.

It was only after the Philippine Embassy in Paris contacted the DOH that it received a copy of Garin’s program three days prior to her arrival.

"Unethical"

Before ABS-CBN News obtained a copy of Lazaro’s report, Garin’s meeting with Sanofi officials was talked about only in whispers in the medical circle. But the whispers probably became too loud.
Asked about the meeting between Garin and Leroy in an interview in May 2017, Garin’s successor at the DOH, Paulyn Ubial, told ABS-CBN News she knew nothing of it, but said a mouthful just the same.

“I can’t judge that (her visit) was legal or illegal, but it’s unethical,” Ubial said.

“You’re not supposed to have any business with the manufacturer or supplier. It’s in our code of conduct. The Secretary is the head of the procuring agency so we should not have any association with the supplier,” she said.

Ubial also said that the Secretary of Health generally does not have any technical expertise, and it would be difficult to justify why someone of that position would tour the facility. “We don’t do that, the Health Secretary doesn’t do that, we send technical experts to review. I wouldn’t even know what to look for in the factory or plant,” she said.

Big investment

The €300 million facility was a “big investment” on the part of Sanofi-Pasteur, the report said. “Normally, pharmaceutical companies build industrial facilities only after the licensing and approval of the product.”

No country had approved the product at the time of Garin’s visit in May 2015.

Sanofi-Pasteur lodged an application to market Dengvaxia in European Union states as well as Iceland, Liechtenstein and Norway in April 2016, but the European Medicines Agency is only set to issue a decision in the second quarter of 2018.

Before the Dengvaxia controversy erupted late in November, Garin had repeatedly said that the proposal to purchase the Dengue vaccines was made in December 2015, after the Department of Budget and Management solicited proposals for projects that could be funded using the savings of the Miscellaneous Personnel Benefits Funds of different government agencies.

Unusual interest?

But the reported meeting between Garin and Leroy in May 2015 seemed to refute that claim.

The meeting showed the level of interest in the purchase of Dengvaxia long before the DBM had called for proposals. It also came long before the Food and Drug Administration of the Philippines granted the vaccine a Certificate of Product Registration in December 2015, and long before the Philippine Formulary Executive Council debated on the procurement of Dengvaxia in January 2016.

And it came long before the World Health Organization released in April 2016 a series of considerations for governments contemplating introduction of the vaccine.

Garin has said she is ready to face any investigation on the vaccine and what she did three springs ago in Paris.