Timo Wolken’s draft report on the Pharmaceutical Regulation

On 4 October 2023, the draft report of Tiemo Wölken (S&D, DE) on the regulation was published. The Rapporteur welcomes the long-awaited proposals for the pharmaceutical Regulation and Directive, recognising them as pivotal elements of the European Health Union.

From an analysis of the document, the major key points are summarised here:

  • The stark contrast between the approaches taken by the two leading rapporteurs on the file comes as no surprise. MEP Wölken's draft report on the Regulation and MEP Weiss's on the Directive diverge significantly. In particular, MEP Wölken’s stance stands out due to his strongly worded critique of what he sees as the industry prioritizing profitability over public health needs. This view is clearly reflected in Wölken’s report, which includes several proposals that may be viewed as radical, such as further reduction of the ME period for OMPs and the complete deletion of the provisions related to the TEV system and regulatory sandboxes. Despite the declared intention to cooperate with the counterpart for the Directive MEP Weiss (a statement curiously absent in Weiss’ draft report), Wölken’s approach is expected to face resistance.
  • While some aspects may appear radical, there are also amendments aimed at fostering industry satisfaction, particularly with the extension of criteria for OMP designation. On the other hand, the adjustment of the definition of HUMN, transitioning from "meaningful reduction" to "substantial reduction," signifies a more stringent standard for orphan medicinal products to qualify for the special status of medicine.
  • The proposal leans in favour of generic and biosimilar developers, as evidenced by the introduction of specific rules enabling their entry into the market, specifically applicable to new orphan therapeutic indications or well-established use cases and provided that the generic or biosimilar are for other uses that are not subject to the MP.
  • While such a radical approach might be interpreted more as a political message rather than an immovable position on the file, room for compromise seems particularly slim considering the diametrically opposed views and the tight timeline the rapporteurs are aiming at. In other words, a first-reading agreement could be seen as less likely.


Date: 24/10/2023 | Tag: | News: 1503 of 1554
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