EU Regulatory Roundup: HPRA Reduces Fee Increase After Pushback from Industry

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
 
HPRA Reduces Fee Increase After Pushback from Industry
 
Ireland’s Health Products Regulatory Authority (HPRA) has reduced its 2020 fee increase in the face of pushback from industry groups. HPRA will now enact a general fee increase of 2%, rather than the previously planned 3%.
 
In October, HPRA proposed increasing all human medicine, compliance, blood, tissue and organs and medical device fees by at least 3%. HPRA argued the increase was needed to enable it to cover rising costs relating to Brexit, the incoming European Union medical device regulations and a general uptick in the complexity of the products it oversees.
 
The industry hit back with reports of its own financial difficulties. HPRA summarized the responses this week in a consultation outcome report, noting that one group representing the human medicine industry expressed “disappointment” at the fee increases.
 
That disappointment stems from the fact the fee increases would place “additional burden” on the drug industry at a time when it is contending with the impact of Brexit and the Falsified Medicines Directive. Another trade group called for HPRA to show “restraint” when setting its 2020 fees. That message has driven a change in policy.
 
“HPRA acknowledges that it is a difficult year for the pharmaceutical industry with Brexit and the additional responsibilities and costs arising out of the falsified medicines directive. In light of these considerations, we revisited the fee proposal and consequently we have reduced the general increase from 3% to 2%,” the Irish regulator wrote.
 
For some companies, the changes may not be enough to alleviate their financial difficulties. HPRA is open to working with these companies. Specifically, HPRA is encouraging companies to approach it if they sell “essential medicines with very small markets” or face issues arising from Brexit, including fees, that may prevent market access.
 
HPRA’s response suggests it is pushing ahead with significant fee increases and the creation of new charges in its medical devices operation. Many of the 3%-plus increases HPRA proposed in October targeted the medical device industry, reflecting the impact of incoming EU regulations. However, the consultation outcome report published by HPRA lacks any information about medical devices. None of the four respondents to the consultation are described by HPRA as being in the device industry.
 
The only targeted fee relief confirmed in HPRA’s response to the feedback relates to the maintenance fee it charges for products that are not marketed. After a manufacturer raised concerns about the fee increase, HPRA chose to keep its maintenance charge flat in 2020. HPRA will review the fee in 2021.
 
Consultation Outcome
 
Off-Patent Drugmakers Push for Cuts to Regulatory Complexity and Costs
 
A trade group representing the off-patent drug industry has written to the European Commission to request changes to mitigate drug shortages. The group, Medicines for Europe, wants authorities to reduce the complexity and cost of regulations that apply to off-patent manufacturers in the EU.
 
In the letter, the trade group argues that the austerity measures EU countries took after the financial crisis, changes to the Chinese active pharmaceutical ingredient industry, Brexit and the Falsified Medicines Directive have combined to put the squeeze on the off-patent drug industry. Faced with these pressures, the trade group argues manufacturers have been unable to make the investments in manufacturing needed to ensure the continuous supply of medicines.
 
Medicines for Europe wants the Commission, which reformed under a new leader this week, to take near-immediate actions to alleviate the pressures its members face.
 
“Europe should Introduce measures to reduce the complexity and cost of EU regulation in the off-patent sector and to facilitate shortage mitigation, including emergency variation and new application procedures and measures to increase the attractiveness of supplying medicines for smaller European markets,” Medicines for Europe wrote.
 
The open letter also called for the creation of a mechanism that enables member states to cooperate to ease, or at least not exacerbate, supply shortages and policies to stimulate investment in medicine manufacturing. Medicines for Europe also sees a role for the Commission in getting member states to drop the post-2009 cost-containment measures that it argues “have clearly reduced competition in the generic medicines sector.”
 
Open Letter
 
Commission Calls for EU Member States to Spread Pricing Knowledge
 
The European Commission has identified a need for member states to cooperate with EU bodies and each other to improve access to affordable medicines. As member states have shared challenges, the Commission sees value in greater cooperation to bridge information gaps that disadvantage payers.
 
Currently, the fragmented nature of pricing and reimbursement negotiations in the EU means there is limited cooperation between member states. In a chapter of its State of Health in the EU report titled “Breaking down silos for safe, effective and affordable medicines,” the Commission called for this to change.
 
“A first step towards balancing the bargaining power of stakeholders consists of bridging information gaps that may put payers at a disadvantage in the pricing and reimbursement negotiations with manufacturers. Fostering greater cooperation among EU countries in this regard could offer promising opportunities to improve the affordability of medicines through more transparent pricing and greater competition among manufacturers,” the Commission wrote in the report.
 
Elsewhere in the report, in a section on antitrust rules, the Commission argued more collaborations involving European competition bodies and national regulators would improve knowledge of pricing methods.
 
Commission Report
 
Spain Gives Device Makers More Time to Change Labels After Brexit
 
The Spanish Agency of Medicines and Medical Devices (AEMPS) is set to give medical device companies until the end of June to change product labels and instructions in the event the United Kingdom leaves the EU without a deal early next year.
 
In a statement, AEMPS said it is aware of the difficulties Brexit is creating for medical device companies. The list of tasks facing the companies includes the updating of labeling and instructions.
 
While the power to grant some relief to medical device companies rests at the EU level, AEMPS is equipped to free businesses in Spain from the need to update labels and instructions as soon as the UK leaves the EU. AEMPS has used that power to reset the deadline to 30 June.
 
Whether companies actually need to change labeling by then will depend on the outcome of the UK election next week and its effect on parliament’s willingness to pass the existing withdrawal agreement. 
 
AEMPS Notice (Spanish)
 
Swedish Medical Products Agency Proposes Relaxing Maritime Drug Rules
 
The Swedish Medical Products Agency (MPA) has proposed relaxing regulations on the purchasing of medicines by representatives of maritime vessels.
 
Currently, the representatives of Swedish vessels can order medicines. MPA thinks there are good reasons to assess whether Sweden should extend that privilege to the representatives of foreign vessels. The agency is also advising the government to consider allowing maritime operators to order narcotic drugs without using a Swedish prescriber as an intermediary.
 
MPA made the recommendations to inform a government review of the regulations covering the maritime and aviation sectors. Most of the proposed changes relate to the maritime sector, which MPA thinks would benefit from fewer restrictions on the ability to stock ships with medicines needed to deal with illnesses and medical emergencies that arise while at sea.
 
Staff at MPA collaborated on the proposals with their peers at the transport agency.
 
MPA Notice (Swedish)