EU-US to address pharma standards, China MedTech protectionism

The EU and the US are expected to extend the mutual recognition for manufacturing standards to plasma and vaccines while continuing the monitoring of protectionist developments in China related to medical devices.

Pharmaceuticals and medical devices will be on the agenda of the third meeting of the Trade and Technology Council (TTC) between the US administration and the European Commission that will be held in Washington next 5 December.

Established in June 2021, the TTC is an initiative that provides a permanent platform for transatlantic cooperation to key global trade, economic, and technology issues.

In a draft of the final joint statement seen by EURACTIV, both partners say they will “work on considering the necessary steps to extend the scope of the EU-US Mutual Recognition Agreement annexe for Pharmaceutical Good Manufacturing Practices to include vaccines and plasma-derived pharmaceuticals for human use.”

Pharmaceutical Good Manufacturing Practices (GMPs) are the minimum standard that pharmaceutical manufacturers must meet in their production processes.

They are routinely inspected by the Food and Drugs Administration (FDA) and the European Medicines Agency (EMA), respectively, the US and the EU regulators for drugs and medical devices.

In 1998, the EU and the US signed a broad mutual recognition agreement (MRA) to ease part of the regulators’ burden by minimising duplicative inspectional efforts by the US and the EU.

An Annex of this agreement was devoted only to pharmaceuticals and was limited to inspections of facilities manufacturing human drug products.

However, the pharmaceutical Annex experienced some pitfalls in its implementation and needed a revision in 2017. At that time, the EU and the US were already evaluating the possibility of including other regulated products, such as veterinary products, human vaccines, and plasma-derived drugs.

If the draft is confirmed in the end, this will mean that the FDA may rely on the inspectional findings of EU member states in a European facility of vaccines or plasma-derived medicinal products that will export to the US.

Conversely, an EU member state may accept the FDA’s inspectional findings at a US facility that exports to an EU country.

Alert on China’s protectionism on medical devices
In another part of the draft, the transatlantic partners expressed their concerns “about the threat posed by a range of non-market policies and practices, for example, in the medical devices sector.”

The reference is to the recent protectionist trend that saw China closing off its medical technology market to external producers through slow certification processes and discrimination against importers in public procurement.

China is among the main European medical trade partners for medical devices, accounting for 12% of the export destination of the European medical devices market in 2021, according to the EU’s trade association MedTech Europe.

“China resorts to various measures to support its domestic industry in the medical devices sector, including opaque approval systems as well as public procurement policies,” said Trade Commissioner Valdis Dombrovskis in February, replying to a parliamentary question on the matter.

Dombrovskis added that medical devices importers have reported that tenders previously open to imported products now specifically ask for domestic products.

The draft on the table of TTC says that “the United States and the European Union have analysed and exchanged relevant data, and examined the market presence of U.S. and EU medical devices companies in China,” following inputs received from stakeholders.

The goal of this analysis was to “better understand the challenges faced by the impact on U.S. and EU companies.”

One of the main issues for the reciprocal opening of the procurement markets is that China is not a party to the World Trade Organisation (WTO) Government Procurement Agreement (GPA).

“Nonetheless, the Commission has been expressing concerns over market access barriers with the competent Chinese authorities,” Dombrovskis stressed in his reply. EurActiv