The European Fee’s said intention is to enhance entry to modern medication on the nationwide stage all through the EU. Firstly, in keeping with the proposal for the reform of EU pharmaceutical laws, there are nonetheless appreciable variations in entry between nations. Secondly, drug improvement has to this point solely been geared to a restricted extent to the precise wants of sufferers. Based on the German Institute for High quality and Effectivity in Well being Care (IQWiG), the latter level is consistent with the attitude of the well being care system {that a} new drug is modern if it improves well being care, i.e. has an added worth for sufferers in comparison with present remedy choices.
In its remark, IQWiG factors out that the EU Regulation on European well being expertise evaluation (HTA Regulation), which got here into pressure in January 2022, additionally goals to enhance entry to medication with added worth (additional advantage) on the nationwide stage. The Institute additional states it’s a requirement that the brand new EU pharmaceutical laws subsequently additionally promotes and calls for drug improvement that solutions the questions of nationwide well being techniques about the additional advantage of medication, and never solely permits advertising and marketing authorization on the European stage. Though the proposal for the reform makes an attempt to satisfy this requirement in some locations, it doesn’t accomplish that general for quite a lot of causes.
IQWiG welcomes the suggestion to additionally make the length of market exclusivity for a brand new drug depending on the standard of the proof submitted. Nevertheless, the deliberate 6-month extension interval for conducting comparative research is way too quick. In IQWiG’s view, it’s crucial to increase the extension to 2 years and, in return, to shorten the at present deliberate new primary 6-year interval of patent safety.
Based on the EU Fee, comparative research ought to solely result in an extension of market exclusivity if they’re performed with an evidence-based comparator. That is additionally the opinion of IQWiG. Nevertheless, the Institute criticizes the deliberate process for figuring out such a comparator. The crux of the matter is that there are not any plans to contain the nationwide HTA companies on this course of. “Nevertheless, it’s exactly the competence and accountability of the HTA companies to evaluate the appropriateness of comparators for direct comparative research,” says Thomas Kaiser, IQWiG’s Director, and requires HTA companies to take part within the consultations and in addition within the choices on which comparators are specified.
Study from experiences within the COVID-19 pandemic
As IQWiG notes in its remark: “Sooner or later it would additionally solely be attainable to establish actual progress in drug remedy on the idea of high-quality proof. And solely then will or not it’s attainable, by way of sooner entry and/or monetary incentives, to prioritize the uptake of drug improvements that symbolize actual therapeutic progress into nationwide well being care techniques throughout Europe, thus reaching one of many important aims of the reform of EU pharmaceutical laws. The topic of a reform of this laws should subsequently be not solely to incentivize the era of high-quality proof, but additionally to scale back the hurdles on this regard.”
On this context, in IQWiG’s view the experiences of the COVID 19 pandemic ought to be thought of: The main advances within the discipline of medication and vaccines have been achieved by way of pragmatic randomized managed trials (RCTs) with quick preparation durations. These embrace not solely the massive part III research on vaccine improvement, but additionally platform research evaluating a number of remedy choices. IQWiG refers back to the RECOVERY research performed in the UK, which on the early stage of the pandemic confirmed a survival profit for dexamethasone in severely sick sufferers [3].
Set incentives for comparative research and EU-wide market entry, additionally for orphan medication
In its remark, IQWiG additionally advocates incentives for high-quality proof and EU-wide market entry for orphan medication. The truth that round half of orphan medication don’t have any confirmed additional advantage over the present commonplace of care is typically attributable to the dearth of enough comparative knowledge. On the one hand, you will need to set incentives for the conduct of comparative research. On the opposite, it’s crucial to supply a wonderful EU-wide analysis and knowledge infrastructure, particularly for uncommon ailments. The earlier proposals for the European Well being Knowledge Area (EHDS) and the linked DARWIN system at present fall wanting the attainable choices, as a result of interventional research should not envisaged in these buildings. Thomas Kaiser emphasizes: “The reform of EU pharmaceutical laws presents the chance to counteract this improvement within the EU analysis panorama and to allow glorious analysis sooner or later. This chance have to be seized urgently so as to not lose out – additionally on the regulatory stage.”
