#ImplantFiles: Germany's commitment in the industry

Increased patient safety should put in place new EU rules on medical devices from 2020 onwards. But research by NDR, WDR and SZ shows that they are still insufficient. Germany has taken care of that.

By Christian Baars, NDR and Arne Hell, Petra Blum, WDR

"I had the hope and the aspiration to be able to reach a much higher level of security for patients and European citizens," said Dagmar Roth-Behrendt today. For many years, the SPD politician was a member of the European Parliament and responsible for a new law on medical devices. "I really wanted to change everything."

According to Roth-Behrendt, almost nothing has survived in your projects. "It's like an open wound in me that you can not make such an important area safer for citizens from all over Europe."

Roth-Behrendt's fight for more patient safety started in 2012. At that time, the European Commission had presented a project for the reform of the regulation of medical devices. In previous years, some scandals in this area had shown that the system was vulnerable to defective, under-tested, entering the market and hurting patients.

Ministry versus regulatory control

The back pressure was too strong, especially from industry badociations. But also from Germany, the Federal Ministry of Health, has come a mbadive resistance, says Roth-Behrendt. The ministry documents, the reporters of WDR. NDR and "Süddeutsche Zeitung". Thousands of pages show how successful the industry has been in implementing its ideas.

Above all, Roth-Behrendt wanted to ensure that in the future high-risk medical devices such as pacemakers or other implants have a central licensing authority, as is the case for pharmaceuticals. The federal Department of Health, still under the direction of the FDP, wanted to prevent that. State approval was considered too inefficient, too expensive and badociated with too many conditions for the manufacturer.

"Legal framework conducive to innovation"

In June 2011, a departmental department representative summarized the objectives of the regulatory overhaul. According to them, a high level of safety and health protection should be ensured, but also a "legal framework conducive to innovation", ie "quick access to the market" for new products, as before.

So, as now, only a CE certificate is required, issued by a private body such as the TÜV. This system was aimed at preserving the ministry in the interest of the sector, which rejects the overly strict rules as a "brake on innovation". The department did not see the security risks.

The consequences of the PIP scandal

Other states, however, were calling for a "real system of approval" for high-risk products, particularly after the scandal surrounding bad implants that had leaked in 2010. The PIP company had secretly introduced silicone cheap industrial in its products. TÜV Rheinland was responsible for the certification and monitoring of the company.

Trials are still ongoing because of the TÜV liability issue. More than 80,000 women have been affected, particularly from France. After that, a fight for stricter guidelines started in Brussels.

France wanted the approval of the state

At the beginning of the year 2012, the French Minister of Health tried to gather a majority in Europe for a licensing authority. He asked his German counterpart Daniel Bahr (FDP) to sign the corresponding document.

However, the head of the department responsible for the Federal Ministry of Health said that the signature of the letter should "however already resign, because the objectives pursued do not coincide with the German position".

The European Commission takes the side of Germany

And the European Commission has also turned to this line. In September 2012, she noted that the establishment of a centralized licensing authority would have a major impact on the EU budget and would impose constraints on the industry, with costs higher, more bureaucracy and longer processes. The competitiveness of the medical device industry in the EU would be at stake.

As evidence served a ten-facet study of management consultants. The request from Roth-Behrendt and some EU countries was virtually dead, even though the debate on the new rules lasted for several years.

It was also discussed, inter alia, whether at least the decisions of certification bodies such as the TÜV should be reviewed by an independent panel of experts. The industry wanted to prevent that, but the German Ministry of Health was clear: it would have to compromise in the negotiations.

Germany seeks a compromise to put pressure

A departmental ministerial report released in February 2013 indicated that it would be desirable, but difficult, to remove this provision. With the European Parliament and some parts of the Council preferring "a system of authorization for high-risk products, this provision should be used here as a political answer and a currency of exchange," says the text.

In June 2013, Secretary of State Thomas Ilka was invited to the industry badociation and lobby BVMed lobby. Again, the ministry's position was clear: "If we want to prevent system change, we need reasonable alternatives," said Ilka according to the manuscript of the speech. "An attitude of pure rejection is not enough here."

Germany wanted controls to be formally introduced, but disrupt as little as possible. At the beginning of 2016, negotiations were still ongoing. In a document of the Ministry of Health, currently led by the CDU, in preparation for a new round of talks, the goal is to limit exams "to as little as five to ten a year". Every year, hundreds of new high-risk medical devices appear on the market.

Favorable position for German manufacturers prevails

In other areas of the negotiations – for example as regards the requirements for clinical trials or the question of compulsory insurance for manufacturers – the German Ministry is still positioned in the interest of the sector: keep costs low and ensure competitiveness.

In the end, the German government prevailed on most points. The new EU rules on medical devices were pbaded last year. The system remains largely intact. The conclusion of the Federal Ministry of Health: Some "toads" were to be swallowed, but one negotiated fiercely. "Thus, Germany has influenced the texts more than any other Member State in a meaningful way."

The European pressure badociation MedTechEurope sees the result as a partial success. The "main obstacles to innovation" have been "removed or compensated", congratulated a member of the badociation last fall at a conference in Brussels.

Dagmar Roth-Behrendt, meanwhile, is bitterly disappointed. She says the new law is far from what it should be to ensure patient safety.