After the storm

| April 19, 2017

The European Union has now fully implemented the Tobacco Products Directive, including its rules on vapor products.

By Peter Beckett

Peter Beckett is managing director at PolicyMatters, a leading compliance consultancy specializing in the Tobacco Products Directive. He was head of policy for the Electronic Cigarette Industry Trade Association from 2013–2016.

Two and a half years after it was agreed in Brussels, the deadline for notifying existing products in the EU rolled around on Nov. 20, 2016. The intervening period saw frenzied preparatory meetings and attempts to understand what the Tobacco Products Directive (TPD) meant.

While clarity has been forthcoming in some areas, there was precious little in others: What level of detail would be required on the toxicological profiles of ingredients? What methods should be used for emissions studies? Who would actually look at this data once it had been submitted? We still did not really know the answers when D-Day came along, and in many cases we still don’t.

What was known was that a good effort had to be made to submit justifiable data on ingredients and the known toxicological data on them—emissions studies, quality management. Ingredient disclosures proved to be one of the hardest hurdles to clear. Flavoring companies were understandably nervous about simply handing their intellectual property over to the hundreds of small and medium-sized companies asking for it. Relationships had to be built between these companies and the ever-growing number of TPD consulting companies, and in the end, most of the major suppliers to the industry provided the data companies needed for submission.

Once the ingredients disclosures were obtained, the next step was sourcing reasonably priced toxicological research and emissions services. Many started out seeking the best, but thousands of pounds for a comprehensive emissions study and thousands more per day of a toxicologist’s time added up quickly.

By the time submissions were due, prices had fallen substantially as laboratories took to reducing the number of replicates per emission, meaning each product would only be sampled once rather than three times. At PolicyMatters, we solved the toxicology question through automation, partnering with regulatory software experts at GegaHelix so our clients can use literature searches that are automated and therefore a fraction of the cost.

And as soon as you had all of that—plus a few other dossiers on nicotine delivery, leak-free refilling and production systems—all of this needed to be submitted to the country where it was to be sold using a centralized system created by the European Commission. This process is not as easy as it sounds.

No one who was involved will forget the two-week lead-in to deadline day. About 10 days out from Nov. 20, the e-TrustEx portal—an email-like web interface that was supposed to allow you to upload your notifications—crashed. It stayed offline for nearly a week.

Panic ensued. Compliance companies that had been working on the directive for years began contacting clients and going back on promises they had made to submit notifications by deadline day.

Three days out from the final deadline the system mysteriously started working again. The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) received 1,000 notifications in a single day, but with so much time lost, the IT creaked under the weight of companies rushing to submit their notifications.

A visibly exhausted Beryl Keeley, the MHRA staffer charged with running the U.K. e-cigarette notification scheme, gave a speech at the E-Cigarette Summit in London. The agency could barely contain its frustration with the commission for the mess it made of the submission system. But she promised that the MHRA would give some leeway to late submitters in an email.

That email came as a relief to many; now, if the portal failed and you had good reason for being late, you could simply email the MHRA and tell them, and they would assume you had registered by the deadline. But that was only good for the U.K.—other EU countries made no such declarations.

So the race was still on. Every PolicyMatters client got their submissions in on time—even the ones that asked for our help at the last minute—but by the end we had sleep-deprived teams working on notifications in the U.S., Europe and China.

The e-TrustEx crash was compounded by the fact that the European Commission had provided inadequate software for companies to create the notifications in the required format. They need to be written in XML—which is a kind of computer code—and the XML is validated once it is submitted. In order to make this possible, the commission provided companies with an XML creator app that would spit out submissions that could then be validated by the system.

Unfortunately, this new government-created computer system performed in the same way as most new government-created computer systems do: poorly. Getting all the data entered took hours for each product variant and was not a fun job. The app also had a nasty habit of crashing in the middle of a session and changing certain values within submissions without notifying the user.

We managed to partially circumvent this by modifying the XML creator app so that it would allow us to make copies of notifications we had already prepared. This saved us and our clients hundreds of man-hours on data entry.

By the time all was said and done, 10,000 vapor products had been notified in the U.K. alone, netting the MHRA north of £1.5 million ($1.86 million) in fees. Today, the number of products stands at almost 15,000 and growing.

A number of companies have experienced problems post-notification. Some submitted using the wrong submitter ID; others used proxy services to submit and now have no idea exactly what they have submitted and no way of prizing the information out of the companies they hired in good faith to make sure they complied with the notification requirements.

And there remain new products to be submitted. One great advantage of the TPD system as opposed to that in the United States is that new products can be launched six months after they are notified.

On May 20, all those products that were not notified or those that do not meet other requirements such as the 10 mL maximum bottle size or the 20 mg/mL nicotine limit must be removed from the market. Market surveillance agencies across the EU have been briefed on the importance of this date, so we can expect vape shops to be inspected to make sure that they are complying with the law.

The industry has grown stronger as a result of going through this pain barrier. They have learned how to engage lawyers and consultants and laboratories and scientists, and they have learned the importance of record keeping and maintaining good relationships with regulatory bodies. And now that we are much clearer on the parameters, future Tobacco Products Directive notifications and compliance will be significantly easier and more straightforward.

 

 

 

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