Expert: Recent ECJ ruling could lead to standards development tumult

Earlier this month, the European Court of Justice (ECJ) ruled there is “an overriding public interest” for the European Commission (Commission) to disclose harmonized standards, opening a potential can of worms for standards development bodies that could have major implications for standards organizations and healthcare product developers that rely on such standards.

On 5 March, ECJ overturned a lower court ruling in the case Public.Resource.Org Inc. and Right to Know CLG v Commission that found the Commission was within its right to refuse to provide conformity standards in response to a Freedom of Information request. With that case overturned, companies that want to conform to a standard could obtain the standard from the Commission, rather than buying it from a standards body, like the International Organization for Standardization (ISO) or International Electrotechnical Commission (IEC.

The right-to-know groups have argued that harmonized standards developed by for-profit organizations are effectively treated as law since the Commission asks companies to conform to them. The Commission, however, argued that standards are optional, and companies don’t need to follow the standards to conform to its regulatory requirements.

ECJ, ultimately, sided with the right-to-know groups stating that while harmonized standards are protected by copyright, it disagreed with the Commission’s reasoning that there wasn’t an overriding public interest to withhold them in response to freedom of information requests because they were in essence being treated as law.

Erik Vollebregt, a partner at Axon Lawyers, told Focus that while the courts have ruled that harmonized standards are effectively treated as law, they are developed by private organizations that rely on fees to do the work. He noted that the fundamental question that was raised by the right-to-know groups is why anyone should have to pay to know the law in a democratic society.

“ISO is not a government. IEC is not a government. These associations earn their money by selling access to these standards based on their copyright,” said Vollebregt. “What happens if you have legal text that are copyrighted but you have to basically pay to know what the law is? Which is weird.”

Vollebregt said the main dilemma is that the Commission has created a system that in large part depends on outsourcing the development of harmonized standards to private organizations but now it must figure out how to provide that legal information to the public for free per the court’s decision. He noted that the system is very similar to how the EU has outsourced market access to notified bodies who conduct conformity assessments for a fee.

“This leads to a breakdown of the logic of the system because basically, the EU thought they had a very clever system where standard development paid for itself,” said Vollebregt. “As a government, you can develop all these standards yourself, which costs you a lot of money and resources, but you can also outsource the process, which basically they did.”

“But now we have the dilemma that if the Commission is forced to provide harmonized standards for free upon a freedom of information disclosure request, what is that going to mean for standard development?” he added.

While ECJ ruled that the Commission did not have an overriding public interest to refuse to disclose harmonized standards, it did not order the Commission to turn over those standards either. Vollebregt said that theoretically, the Commission could be inundated with requests for harmonized standards and may try to find another overriding public interest argument to stop from having to hand over such standards in response to such requests.

Vollebregt said the Commission has a major interest in trying to refuse standards disclosures because the standards development bodies may refuse to stop making standards since they won’t be able to pay for their development. He added that without standards, product developers will have a harder time conforming to EU regulations.

"If a harmonized standard is free, it might be that we get a temporary stop in the harmonization process," said Vollebregt. "Which basically brings us to where we've been with the [Medical Device Regulation (MDR)] and the [In Vitro Diagnostics Regulation (IVDR)] for a long time, where you would have new versions of standards which would also reflect the state of art, but they were not harmonized yet, because there has been such a big harmonization backlog."

He added that due to the lack of MDR and IVDR harmonized standards, notified bodies have been recognizing international standards that are not harmonized.

Vollebregt noted that under the current law, the Commission also can’t act as a standards organization to develop standards and if it were allowed to develop standards that would require a massive government investment. He added that if the Commission ultimately did also develop standards, they could potentially be paid for through user fees or increased taxes.

Since the ECJ decision came down, there hasn’t been a lot of updates on whether the Commission has received more freedom of information requests for standards, but Vollebregt suspects that may be happening behind the scenes.

“Everybody's really silent about this, but it's a huge elephant in the room,” he said. “It might be that there's a huge pile of freedom of information requests lying around the Commission now which is getting increasingly higher.”

Vollebregt said that the lesson here is that choice and principles have consequences.

“On the one hand, you can't have constitutional rights that say the law is free for all to know and then outsource the development to somebody that wants to make money to essentially develop law for you,” he said. "So now the question is, what is this going to mean for the European standardization system? I don't know."

"I think in the typical EU way this is going to be a pressure cooker with mounting pressure and then sooner or later, it's going to blow up sideways and a solution will have to be found," he added. “This is a cost to somebody and if there's a cost, either the government needs to absorb it or the users have to pay for it, directly or indirectly.”

Expert: Recent ECJ ruling could lead to standards development tumult

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