Medicines For Europe Seeking Easier SPC Manufacturing Waiver

As per Medicines for Europe, the Munich District Court’s Supplementary Protection Certificate- SPC manufacturing waiver, which was issued in Germany in October last year, happens to be in conflict with the objectives of the waiver.

The organization as well as its members happen to be strongly concerned by the court’s first judgment on the waiver.

Objectives and issues

First brought-in in 2019, the objective of the SPC manufacturing waiver happened to be to enable the manufacture of medicines under specific conditions during the almost five-year extension of the market protection of specific patented medicinal products within the EU, Medicines for Europe went on to summarize.

As per Medicines for Europe, the waiver looks to preserve the competitiveness of the European generic as well as biosimilar medicines sector, stimulate investments within medicines manufacturing across Europe, and at the same time avoid delocalization within the medicines industry.

It is well to be noted that the group deemed that the Munich District Court’s judgment happened to hold an inordinately restrictive interpretation of the SPC manufacturing waiver that cannot be derived from the letter of law. As such, Medicines for Europe underscored that it goes on to contradict the amendment intentions that were introduced during its prosecution until its final approval.

On the basis of the court’s judgment, SPC manufacturing waivers, when it comes to export, would need notification of a marketing authorisation- MA number and even if no MA number happens to be publicly available or the disclosure of confidential data on a future country of submission, deducing those needs from an alleged requirement to make sure that no intellectual property rights ought to exist in the foreign country of export, Medicines for Europe remarked.

This judgment goes on to state that the SPC manufacturing waiver legislation happens to be at present drafted to enable the SPC holders to misinterpret language before courts to the detriment of EU-based producers and to the advantage of producers who happen to be out of Europe. This indeed threatens investments when it comes to manufacturing, as per Medicines for Europe.

Medicine for Europe also went on to note that the SPC regulation, the reform that is proposed by the European Commission to introduce central granting procedures, goes on to lack some of the original recitals when it comes to the SPC waiver legislation, with more potential confusion taking place.

Manufacturing within the EU

Moreover, the judgment goes on to further suggest that for manufacturing in the EU and exporting to a third country to be permissible, a marketing authorization that is granted in such a third country is needed. The judgment goes on to hold that the regulation is not intended to put manufacturers in the Union on an absolutely equal footing with those of the manufacturers in third countries, Medicines for Europe stated.

This happens to be fundamentally wrong and is indeed a complete misunderstanding of which activities need marketing authorization within pharmaceutical regulatory laws, the organization said.

Medicines for Europe went over to uphold that though it is a first-instance judgment in a fast-paced procedure, issued in a single, but for the pharmaceutical sector, significant, it will certainly be used by SPC holders so as to further threaten existing as well as future users of the SPC Manufacturing Waiver along with lawsuits, or even to sue them.

The group went on to acknowledge that this practice happens to be already been reported by users of the SPC Manufacturing Waiver in the Medicines for Europe 2023 Industry Report, thereby adding that it distorts the usage of the waiver.

In the 2023 Industry Report, Medicines for Europe went on to propose simplification as well as clarification of the legislation.

This action would go on to achieve the objective of the legislation, which is to make the EU attractive for developers as well as manufacturers of pharmaceuticals, make the security of supply more robust, address crucial and important medicine shortages, and also make sure of the timely entry of generics along with biosimilars, the organization underscored. To make sure that this occurs, it called on the EU to have these proposals included now in the common SPC legislation overhaul.