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Panhellenic Union of Pharmaceutical Industry

PEF

The PanHellenic Union of Pharmaceutical Industry (PEF) represents domestic pharmaceutical manufacturers in Greece.

Lobbying Activity

Meeting with Margaritis Schinas (Vice-President)

15 Jul 2022 · Pharma Strategy

Meeting with Margaritis Schinas (Vice-President) and

8 Oct 2021 · Pharma policies

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

The Panhellenic Union of Pharmaceutical Industry, represents the collective domestic pharmaceutical manufacturers of generic medicines in Greece. As National member of Medicines for Europe, the European association that represents manufacturers of off-patent medicines in Europe, we would like to reiterate the below important issues in light of the revision of the general pharmaceutical legislation. -The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry by extending the scope and harmonising the Bolar exemption to cover API supply and all administrative steps needed to effectively launch generic/biosimilar medicines. -The legislation should also ban patent linkage – a major cause of generic/biosimilar entry delays, which the EC considers anti-competitive and “unlawful”. While incentives have generated some success, they should not go beyond their legally defined public objective and abuses/misuses that delay generic/biosimilar competition should be tackled. To encourage competition, access and sustainable innovation, there should be incentives and regulatory reforms to encourage the development of follow-on orphans and off-patent paediatric products. -The pharmaceutical legislation should recognise VAM as a separate category of innovation with proportionate incentives. Value added medicines (VAM) are an opportunity for continuous innovation on off-patent molecules for unmet medical needs, e.g. reformulation of off-patent antibiotics to tackle AMR, repurposing in oncology. The regulatory system needs to be updated to keep a resilient off-patent sector by: • The use of telematics tools for regulatory efficiency • short and predictable timelines • adapting to new digital or technological developments -To prevent continued consolidation of the market and manufacturing, supply chain resilience should be strengthened via procurement reform that includes criteria other than price and encourages multiple manufacturers to supply the market. -Single global development is a key enabler of efficient generic drug development and the unethical duplication of studies in humans. It is important to tailor regulatory pathways for maintenance, approvals and regulatory learnings as well as enabling multi-source competition at loss of exclusivity of the reference drug. Amendments to the Variations Regulation and Variations Classification guidelines are needed to reflect the science and telematics tools to optimise the regulatory process, avoid duplication and enable a faster reaction to shortages or emergencies. -Any stockpiling of medicinal products must be done rationally: clear demand, financing and management of the stockpile, preventing strain on manufacturing capacities and potential wasteful disposal of unused medicines. Uncoordinated national stockpiling demands should be rejected. -To address the environmental impact of medicines manufacturing and disposal, policies should look at the life cycle of the medicine. Establishing a central EMA ERA database containing all available ERA data submitted by MAHs can identify missing environmental data gaps considering science and risks, and prevent unnecessary duplication. Beyond medicines manufacturing, introduction of e-Pi would bring not only environmental benefits but also greater supply flexibility in a crisis.
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Response to Evaluation economic adjustment programmes Greece.

29 Oct 2020

Effectiveness: Regarding healthcare, the programmes imposed a significant decrease in healthcare spending (between 2009 and 2017) the total healthcare expenditure decreased by 36% and by 43% in the public expenditure. In 2017, the share of public funding in total healthcare expenditure was below the EU average (Greece:60% vs EU: 80%). Private funding accounts for 40% of the healthcare expenditure, a significant financial burden for the patients during the general income collapse observed during the programmes era. This combination broadened health inequalities, increased health expenditures, and hindered access to healthcare. Regarding the pharmaceutical sector, the programmes focused in the reduction of public pharmaceutical expenditure by focusing mostly on supply-side measures, i.e. price decreases, rebates and clawbacks. This approach resulted in short-term, non-viable savings, as it failed to implement structural reforms regarding prescription control, rationalization of consumption and reimbursement, and increased use of generics. On the contrary, the combination of extreme price pressure and the ever increasing clawbacks created a non-viable environment for a series of old affordable medicines that otherwise could produce savings. Eventually these medicines were substituted by newer more expensive ones. The inability to negotiate the reimbursed price and to control the prescription of new medicines, as happens in all EU countries, remains a problem in the Greek market, and was addressed adequately by the programmes. The public pharmaceutical budget ceilings, remain at low levels while the actual expenditure is constantly increasing due to new expensive medicines. This leads to ever increasing clawbacks which “may soon become not sustainable” according to the third Enhanced Surveillance report for Greece by the Commission. In the most recent, seventh report the Commission stated that “the 2019 clawback for pharmaceuticals is 36% higher than in 2018 and almost 65% higher than in 2017.” Notably and very rightly so, the Commission also stated that “a review of the current definition of the clawback introducing a risk-sharing component would be instrumental in enhancing the efforts to avoid the creation of new clawbacks and to curb supply-induced demand, which leads to high out-of-pocket payments.”It is clear that the clawback mechanism although initially enforced as a temporary measure has become a norm in the Greek healthcare system. This has severe economic consequences for pharmaceutical companies. The initial objective and effect of the policy measure has never been realized but rather has caused an unpredictable business environment, resulting to economic restraint on pharmaceutical manufacturers. Efficiency: The programmes by design followed a top bottom approach, e.g. in the case of pharmaceuticals, from the expenditure target towards the rationalization of prescribing and reimbursement. This implied a series of distortions, which didn’t allow the formation of a coherent pharmaceutical policy. While the fiscal targets of the programmes were met, the structural market distortions remained. Even under this strategy, the implementation of the measures remained an unsolved issue, often facing opposition by stakeholders. Coherence: With regards to coherence the policies introduced during the fiscal programmes were consistent yet incoherent, e.g. . although all three MoU’s required the increase of generic penetration up to 60% by volume, this was never achieved and generics penetration remains at the lowest level in EU (2019: 24.5%). The relevant measures failed to consist a coherent policy i.e. extreme price cuts for extreme price cuts for generics while pharmacists are still incentivized to dispense the more expensive alternative, etc. Relevance: The programmes contained a one-size-fit-all toolbox of measures deemed as Good Practices elsewhere but failed to adapt to the specific feature of the Greek health system
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