The European off-patent sector will face monetary challenges to finance new urban wastewater treatment rules if the directive is implemented in its current form, says industry association Medicines for Europe.
The Urban Wastewater Treatment Directive would introduce an extended producer responsibility system, in which “pharmaceutical and cosmetics sectors will have to finance the upgrades of wastewater treatment plants across Europe to introduce the quaternary treatment required to remove persistent substances from all sectors, as well as the operational costs.”
However, the European Commission itself has previously acknowledged that pharmaceuticals are mainly present in European waters due to human consumption and subsequent excretion by patients.
“While we remain engaged in environmental sustainability, the financial burden imposed by this system exceeds the capacity of our sector. It is not too late for member states to assess the impact of the EPR on medicines before adopting the legislation,” commented Adrian van den Hoven, Medicines for Europe’s director general.
According to the off-patent trade organization, generic medicines are particularly vulnerable to this proposal given their “high volumes, narrow margins, and strictly capped prices,” with the costs of the legislation set to “make several essential generic medicines economically unviable.”.
The provisional political agreement on the proposal to review the urban wastewater treatment directive was reached by the European Council and Parliament at the beginning of 2024.
Since then, it has been endorsed by member state representatives and the European Parliament’s Committee on the Environment, Public Health and Food Safety. In April, it was voted in favor by the Parliament, and is now awaiting the Council’s formal approval.
Following the Parliament’s vote, rapporteur Nils Torvalds assured that the “impact of the rules on the affordability of medicines will not be disproportionate.”
“If the UWWTD is approved in its current form, we call on the European Commission and on the member states to ensure that the EPR system does not endanger the availability of essential and critical medicines, and on the European Parliament, that already expressed concerns on the impact on medicines during the legislative discussions, to closely monitor this process,” said van den Hoven.
FDA’s Finalized Guidances And GDUFA Outcomes Report
Throughout the past few weeks, the US Food and Drug Administration has finalized several of its guidance documents.
The “Requests for Reconsideration at the Division Level Under GDUFA” guidance provides procedure recommendations for ANDA applicants, who want to request for reconsideration within the review discipline.
It reflects the most recent reauthorization of the Generic Drug User Fee Amendments and clarifies “what matters are appropriate for requests for reconsideration.”
Next was the “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA” guidance, which is intended for holders of Type II active pharmaceutical ingredient drug master files that will be referenced in ANDAs or prior approval supplements.
This guidance explains how the FDA incorporates a program enhancement that is part of the negotiations relating to the reauthorization of the GDUFA III commitment letter, specifically when a DMF holder can ask for an early assessment and recommendations for such a request.
The agency has also finalized the International Council for Harmonisation’s guidance, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which was adopted by the global organization a few months ago.
It is intended to provide recommendations on conducting BE studies during both the development and post-approval phases of immediate-release solid oral dosage form.
Also, as part of its “enhanced accountability and reporting commitments” in GDUFA II, the FDA published annual outcomes reports for the fiscal year 2023. They highlight the extent to which GDUFA science and research-funded projects support the development of generic drugs, evidence generation needed to support the review and approval of ANDAs, and evaluation of generic drug equivalence.
CGPA Commends Ontario’s Life Science Investment
The Canadian Generic Pharmaceutical Association and its Biosimilars Canada division have applauded the Ontario government’s commitment to invest $146m into the life science sector.
This is part of the Taking Life Sciences to the Next Level strategy, which was introduced by the government in 2022, in a bid to grow the sector and “improve health outcomes by securing new investments in next generation health technologies, medicines and vaccine manufacturing.”
“As the national association representing Canada’s generic pharmaceutical industry and a proud member of Ontario’s Life Sciences Council, the industry plays a key role in Ontario’s healthcare system and economy,” commented CGPA’s president Jim Keon.
He added that “Ontario is the home of Canada’s generic pharmaceutical industry and the majority of its domestic jobs, investments and manufacturing capacity,” with 13 of CGPA’s members based in the province.
Indonesia’s Plans For Accelerated Generics Registration
The Indonesian Food and Drug Authority, also known as Badan POM or BPOM, recently held a forum to discuss the acceleration of the generic drug registration process.
The agency provided key statistics, highlighting expired distribution permits, as well as the dominance of generic drugs in the nation’s formularies.
BPOM urged the pharmaceutical industry to meet its regulatory and quality standards to ensure a smooth registration process. Meanwhile, it plans to complete the acceleration of registration in three stages by addressing 915 distribution permits by the end of the year.
Disputes Over Shift To Cardio Generics In Malaysia
Malaysian independent thinktank Galen Centre for Health and Social Policy has criticized the government’s new policy to shift patients treated at the Kuala Lumpur-based National Heart Institute to generic drugs.
According to a local news service CodeBlue, which is Galen Centre’s editorially independent program, the Ministry of Health has limited available funds to pay for government-dependent patients at the institute, as such switching them from originator to generic drugs.
The Galen Centre’s chief executive Azrul Mohd Khalib argued that it should be up to the National Heart Institute to decide what is best for its patients, especially as not all innovator drugs have biosimilar or generic equivalents.
“It takes time to register new drugs into the market. It would not be possible to make a blanket policy to entirely drop innovator drugs or ethically deprive these patients from being able to benefit from drugs that are already in Malaysia, for the promise of medicines that will one day be available,” Khalib told CodeBlue.
