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Associação Portuguesa de Medicamentos Genéricos e Biossimilares

APOGEN

APOGEN's mission is to disseminate the concepts of generic medicine and biosimilar medicine, actively contributing to the development of this market segment in Portugal, making medicines more accessible, in a sustainable health system, allowing the release of funds for the introduction in the market of truly innovative medicines.

Lobbying Activity

Response to Evaluation and revision of the general pharmaceutical legislation

2 Oct 2023

APOGEN, Portuguese Generic and Biosimilar Medicines Association represents the companies of generic and biosimilar medicines in Portugal, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to safe, effective and affordable medicines, through better competition, an efficient regulatory system and a framework conducive to manufacturing and continuous innovation. Focusing on the Directive, we would stress the importance of: 1. Ensuring predictability and legal certainty to prevent delays in access to generic and biosimilar medicines, by: a) clarifying the Bolar provision to allow immediate day-1 competition after IP expiry, through the inclusion of the supply of EU produced APIs for obtaining marketing authorisations (API supply, offer, export, manufacturing) and all necessary regulatory and administrative steps (MA/P&R list/tender bids); b) modulating market protection rather than data protection, to ensure that in case the originator manufacturer does not supply the product to all EU markets, generic or biosimilar medicines would be approved in time to supply the underserved markets; c) ensuring the cumulative data and market protection period does not exceed the current 11-year cap. 2. Establishing a clear European strategy to prevent and mitigate shortages, by: a) increasing the visibility and transparency of the supply chain through a single interoperable reporting system, leveraging existing data sources like the European Medicines Verification System; b) allowing faster pan-European implementation of electronic product information, starting with hospital products, thus enabling faster reallocation of medicines across Member States. 3. Ensuring an efficient regulatory system that delivers on medicine availability. The proposal already foresees several key provisions to optimise regulatory operations but we still see areas where optimisation can go further to ensure faster patient access to affordable treatments by: a) avoiding limiting the mutual recognition procedure within a year of MA granting b) offering a pragmatic path for the national competent authorities to opt-in national procedures by allowing them to recognise for public health reasons the MA procedure within 5 days after the procedure has been closed c) ensuring a greater flexibility in choosing the marketing authorisation route d) adjusting the ownership of the ASMF to the legal entity that has ultimate responsibility for the ASMF. 4. Adopting a science-driven and risk-based environmental risk assessment (ERA) to reduce the environmental footprint while safeguarding patient access. We support the development of a streamlined process for referencing originator ERA for generic, biosimilar and fixed-dose combination products in order to avoid unnecessary duplication of efforts and delays in access to medicines. In addition, we recommend: a) ensuring that post-MA ERA condition is sufficient for authorisation of products where ERA is not (yet) available b) adopting AMR-related measures for products with a confirmed high risk of developing resistance. 5. Supporting affordable innovation to address patient needs via a clear pathway for value added medicines. The proposal recognises the importance of repurposed value added medicines with a non-cumulative 4-year data protection. We recommend including in the scope all relevant changes which deliver significant benefit to patients, such as repositioning, reformulation and complex combinations, while ensuring the article is not misused for evergreening practices. We are ready to continue the dialogue with the co-legislators, the Commission, patients and other stakeholders to improve medicines availability, accessibility and affordability and achieve an open strategic autonomy in healthcare
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Response to Evaluation and revision of the general pharmaceutical legislation

2 Oct 2023

APOGEN, Portuguese Generic and Biosimilar Medicines Association represents the companies of generic and biosimilar medicines in Portugal, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic areas, we fully share the goals of ensuring that all patients across the EU have timely and equitable access to safe, effective and affordable medicines, through better competition, a more efficient regulatory system and a framework conducive e to manufacturing and continuous innovation. Focusing on the provisions of the Regulation, we would stress the importance of: 1. Ensuring predictability and legal certainty to prevent delays in access to generic and biosimilar medicines, by rejecting the proposed transferable exclusivity vouchers for novel antimicrobials. The vouchers would lead to the extension of monopolies on the most profitable blockbuster drugs, thus breaking the founding principle of the relationship between innovation and reward, unduly delaying patient access to the more affordable off-patent products and dramatically increasing costs for healthcare budgets. To address the AMR challenge, instead of transferring the costs of funding antimicrobials to patients with already limited and unequitable access to blockbuster drugs, Europe should establish a Union multi-country pull incentive scheme to improve innovation, development and access to both novel and existing antibiotics, such as the revenue guarantee mentioned both in the December 2021 and June 2023 EPSCO Council Conclusions. 2. Establishing a clear European strategy to prevent and mitigate shortages. We support the proposed harmonised definitions of shortages and critical medicinal products, but are concerned about extending shortage notifications from 2 to 6 months which would lead to shortage false alarms as happened in Italy and Canada. Instead, a single digitalised and automated reporting system would allow marketing authorisation holders to report shortages as soon as they are aware, without placing an unnecessary burden on either them or the competent authorities. We support the introduction of shortage prevention plans with a risk-based approach, based on a single coherent list of critical medicines or essential medicines with no alternatives to avoid the generation of countless resource-intensive and unnecessary reports, instead allowing manufacturers to focus their resources on preventing and mitigating actual shortages. 3. Ensuring an efficient regulatory system that delivers on medicine availability. While the proposal already foresees several key provisions to optimise regulatory operations, including a shortened marketing authorisation (MA) procedure from 210 to 180 days, it would be critical to ensure the possibility for generic, hybrid and fixed dose combination products marketing authorisations applicants to choose between the centralised and the decentralised procedure. Moreover, removing the requirement for generic and biosimilar manufacturers to duplicate packaging and brand names for use patents by better adapting labelling to the use patent landscape and avoiding confusion among patients due to duplicate MA applications. We are ready to continue the dialogue with the co-legislators, the Commission, patients and other stakeholders to improve medicines availability, accessibility and affordability and achieve an open strategic autonomy in healthcare.
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Response to EU strategic Framework for Global Health

19 Sept 2022

APOGEN represents the generic and biosimilar medicines manufacturers in Portugal. We welcome the Commission’s decision to work on a new EU Global Health Strategy and the opportunity to provide our contribution. The off-patent pharmaceutical sector supplies the majority of prescription medicines, providing equitable access to patients worldwide. The sector has played a crucial role for several infectious diseases like HIV, TB or malaria and can be critical for many other therapeutic areas, including non-communicable diseases. Building also on the Covid-19 lessons learned, the European Union should focus on ensuring greater access to generic and biosimilar medicines, by: • increasing regulatory harmonisation through mutual recognition GMP agreements and single development programmes for generic and biosimilar medicines. Comprehensive mutual recognition agreements facilitate market access and encourage greater international harmonisation of compliance standards, while regulatory frameworks that allow the use of foreign comparator products (single global development) allow to avoid duplication of studies, cut inefficiencies in development programmes and respond better to patient need; • ensuring a good balance between intellectual property, competition and access to medicines in trade negotiations. Any negotiation on intellectual property with third countries should be balanced, taking into consideration the effective impact of intellectual property on generic and biosimilar medicines access and on healthcare sustainability both in the EU and in the relevant third countries; • cooperating with international partners to strengthen APIs and off-patent medicines supply chains resilience. Initiatives such as the EU-US Trade and Technology Council provide an important opportunity, which should be fully exploited, to strengthen strategic supply chains through close cooperation between like-minded partners and the involvement of all stakeholders; • limiting export restrictions and reducing trade barriers for medicines, APIs and any other medicines manufacturing input. This should be ensured both within the EU, in line with the Single Market principles, as well as on a global scale, in line with the WTO Ministerial Declaration adopted in June 2022; • improving the collection and sharing of data on medicines demand, to facilitate scale up of production and efficient allocation of medicines to tackle crises. In this sense, and more in general to increase the efficiency of regulatory and healthcare systems, more efforts are needed from the EU and its global partners to fully harness the potential of the digital transition. We fully share the One Health approach and restate the strong commitment of the off-patent pharmaceutical industry to keep operating in an environmentally sustainable way, while highlighting the need to ensure that any measure taken in this field is proportionate, evidence-based and does not jeopardise patients access to safe and effective medicines. All APOGEN's member companies comply with the standard manufacturing framework of the AMR Industry Alliance, a key example of public-private cooperation aimed at providing sustainable solutions to AMR. We would also like to underline the importance of fostering value-added innovation on existing medicines. This is a powerful tool to increase treatment options and improve the cost-effectiveness of healthcare systems. Value-added innovation can play a key role in the fight against AMR and other public health challenges, as it was the case for Covid-19. We believe that the involvement of the off-patent medicines industry and the adoption of the abovementioned policies will be critical to delivering on the goals of the EU Health Strategy. We stand ready to work together with the Commission and all stakeholders to ensure the new EU Global Health Strategy delivers on its goal to ensure access to safe, high-quality and effective treatments for everyone.
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Response to Unitary Supplementary Protection Certificates (SPC) – creation and granting procedure

5 Apr 2022

APOGEN welcomes the chance to provide feedback on the proposal to reduce fragmentation in the SPC system. The Call for Evidence (CfE) makes almost no reference to a need to tackle fragmentation in enforcement/litigation phase of SPC lifecycles, arguably the highest priority for ensuring timely patient access to generic/biosimilar medicines, legal certainty & address national budget issues, ignoring the core problem: multiple litigation & conflicting national court decisions. The CfE refers to the SPC Evaluation by mentioning four identified problems, disregarding a fifth one identified there: “[c]onflicting outcomes of court proceedings”. Indeed, the IP action plan recognises “parallel litigation in multiple EU countries” & the need to “avoid parallel [court] proceedings in multiple Member States, considerably reducing litigation costs”. The EP Resolution states that “a level playing field for makers of generics and biosimilars in the Union is essential” in the SPC reform. Removing multiple national litigation & conflicting court decisions is considered “urgent” also in the 2009 EC Sector Inq. Report. It is essential for increasing savings for HC budgets & timely competition on the market. The societal impact of timely entry of generic/biosimilar medicines on the market is not a factor included in this CfE. This needs to be urgently recalibrated. No substantive changes to the SPC regulation (esp. Art. 3) or guidelines on best practices would increase legal certainty, but rather create further uncertainties. CJEU is converging towards some stability, progressively returning to an interpretation more consistent with the objectives of the regulation. Therefore, APOGEN believes that Unitary SPC & unified grant system of national SPCs may potentially increase legal certainty in the interest of the whole industry only as long as certain safeguards & considerations are contemplated to ensure a well-functioning system: Scope: Unitary SPCs will increase SPCs geographical scope. Today, SPC is not registered in 8 out of 27 MS, where generic/biosimilars can provide patient treatment at patent expiry. Such geographical extension has the potential to prevent equitable access to treatment where no product is or can be placed on the market Basic patents: for coherence, (i) unitary SPCs should be available only for unitary patent & (ii) the unified granting system should only be available for European Patents Underlying MAs: for coherence & clarity, unitary SPCs & centrally-granted national SPCs should only be available on the basis of a valid marketing authorisation Granting body: permanent virtual body to be established taking advantage of high expertise & best practices from NPO with experience in SPC grants Quality & Transparency: to (i) ensure highest quality & transparency in examination; (ii) include formal mechanism for quality assessment of examiners, incl. outcomes of case-law. SPC applications to be published in a public register as soon as possible after filing with all documents from the file. Should the register include SPC expiries, a clear ban of patent linkage must be made in EU legislation to avoid that it be used to stop P&R or procurement decisions (contrary to EU law, as EC clarified) Pre-grant oppositions: to ensure quality of granted SPCs, the system should foresee a pre-grant opposition mechanism (WIPO defines it a “simple, quick and inexpensive mechanism that ensures the quality and validity”). Since a unified granting system for national SPCs would NOT address multiple litigation, it would only be acceptable if pre-grant oppositions will be included Accountability of granting body: seen the huge impact of granted SPCs on HC budgets, patient access & litigation, the granting body should be fully accountable. Appropriate mechanisms for regular EU institution’s review & reporting should be in place to correct unforeseen deficiencies. No double SPC protection (national & unitary) should exists in a single MS
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Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

Taking the lessons learned from COVID-19, APOGEN has two main reflection points on the proposal: 1. We highlight the important challenges of using joint procurement (JP) for generic multisource medicines. The joint procurement of ICU medicines during the pandemic was not an efficient way to secure medicines supply. The JP lacked transparency and offered little-to-no commitment to purchase from the countries and the EC. Companies awarded were forced to hold stock to fulfil the framework agreement while some of the participating countries organized parallel tenders for the same products generating additional stress to the supply capacity and demand volatility. Result: inventory blocked and unused instead of serving patients needs at risk of causing shortages. We echo that JP is not a suitable method to procure generic medicines. Based on the ICU medicines JP, we believe that there are 6 core lessons: I) Implementation of an ‘exclusivity clause’: countries participating the JP should be prevented from procuring the same products concurrently nationally. Pre-existing national supply agreements must supersede the JP; II) Clear award criteria: tender award criteria and specifications should be discussed before launching the procurement process in an open competitive manner, involving the relevant trade associations and prospective manufacturers. Thus, ensuring they are workable and avoiding unnecessary delays. This would allow the implementation of smart procurement criteria and the process would have been faster with prior consultation of the industry on the criteria which were a source of confusion for procurers and companies. It is incorrect to claim that this was not possible due to the urgency of the situation as the ICU tender took 3 months from launch to award; III) Transparent call for tender and results: the EC and MS must ensure that all companies authorized to market medicines in Europe are able to participate in the call for tender. Additionally, the EC should provide a full account JP procedure to allow its proper evaluation ahead of launching additional calls for tender; IV) Packaging flexibility: when procuring generic medicines that are mostly nationally licenced (DCP, MRP, NP), there should be flexibility and clarity on the packaging, labelling, possibly FMD serialisation, to make it quicker to manufacture and package large volumes; V) Volume commitments: volumes jointly procured must be accurately estimated and have volume commitments for bidders to prevent waste; VI) Healthcare Crisis Focus only: JP should only be carried for the purpose of addressing patient needs during a health crisis and following the Directive 2014/24/EU to prevent any disruptions to the normal functioning of the internal market. 2. We understand the need to buildup an EU reserve of critical medicines. We stress the value of a balanced and coordinated approach to avoid creating a large inventory of medicines at waste risk and potential short-term supply issues. To ensure a functional European reserve of critical medicines, some aspects that must be included: a) Agree on a list of essential medicines for the reserve, based on identified needs in a risk assessment; b) Establish a transparent process to purchase these medicines, identifying who will place orders, purchase the goods, hold the reserve, call off deliveries and under which conditions these medicines can be used. The process should clarify the tasks to be managed at a country and EU levels, involving the relevant supply chain actors; c) Establish clear responsibility for the costs associated with ordering, purchasing, logistics, storage and distribution of these medicines. Logistics should take into account the product characteristics (eg shelf-life) as well as the ownership of the financial risks of obsolescence and destruction; d) Avoid the wasteful destruction of medicines (only needed in an emergency) by using best practice from across Europe regarding rolling reserves.
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Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

APOGEN welcomes the reform of the mandate of the European Centre for Disease Control (ECDC) especially in light of its response to the first wave of the COVID-19 pandemic in Europe when it struggled to collect data from member states and to provide forecasts of the progression of the virus. APOGEN, along with other stakeholders in the field of the pharmaceutical industry, regularly requested dialogues and information from the ECDC to plan manufacturing and supply capacities for therapeutics such as medicines used at intensive care units, vaccines, etc. across Europe. However, we did not receive any useable information from the agency for the purpose of production planning even though this is clearly its main mission (to help the EU with the epidemiology of infections). We believe that the COVID-19 outbreak showed the need to reinforce the surveillance systems and subsequent coordination between the Member States, EU Institutions, relevant European agencies (such as European Medicines Agency) and stakeholders. Special attention should be paid to strengthening the external communication of the ECDC towards the Member States. In our opinion, the mandate of the ECDC is more than a question of more funding. The agency’s role in providing information to the pharmaceutical industry is also critical as surges in patient demand for medicines (emergency medicines, anti-infectives, anti-virals, vaccines) will almost certainly be a feature of future crises. We underline that during the first wave of the Covid-19 pandemic, the pharmaceutical industry in a project led by Medicines for Europe and EFPIA had to conduct its own epidemiological research on the progression disease and on the medicines needed to treat patients. What is the point of funding an agency of epidemiological experts for Europe if, in the end, the industry must do this data collection and epidemiological calculation on its own? We understand that it is challenging to provide epidemiological projections to fit an industrial planning timeframe of 2-4 months but that is where epidemiological predictions can serve a public purpose. Medicines for Europe is prepared to work with the Commission and ECDC to share its experience on how this future work could be developed to avoid this scenario repeating itself in the future.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

APOGEN, taking into account to the lessons learned from COVID-19 crisis, believes that the proposal on management and mitigation of medicines shortages should be improved for better outcomes of the collaboration between the manufacturers and National and European medicines agencies to improve the supply of medicines to patients and to ensure EU solidarity. We would like to see a proposal for a robust harmonized digital reporting system for shortages in Europe by all EU national competent authorities (NCAs), which would be built on a common definition of medicines shortage and based on common data fields. The system should be primarily based on collecting data on the national level, where the MAHs would report into the shortage reporting database. With data collected in harmonised fields, the EMA could receive aggregated data from national databases to monitor any potential cross-border shortages and to effectively intervene to mitigate or even prevent the possible consequences of such a shortage for patients. For such a system to be truly functional, the electronic form and data submitted should be compliant with ISO IDMP standards for the identification of human medicines and be based on a harmonised data template and with interoperability with SPOR data. This would allow EMA, national agencies and industry to identify medicines by using the standard and process with the benefit of reducing the duplication of manual data filling and risk of human error as it is today, avoiding redundant notifications of the same shortages, and improve data-sharing. The advantage of this approach is also its scalability as most reporting only concerns national markets. This approach would avoid the creation of massive data sets of little or no relevance to the EU level and allow the EU, member states and industry to focus their resources on where it matters most. To be able to respond adequately to any emergent large-scale crisis, there is a need to quickly identify critical medicines to secure their supply chain in the affected Members States. This should be done in collaboration with the manufacturers. Medicines for Europe and EFPIA led a project on this for ICU medicine supplies and it is imperative that the EU consider reusing this approach (Commission Decision, Competition law comfort letter, oversight by DG SANTE jointly with DG Competition) as only the industry can engage in production scale up to meet demand surges. Related to this, there should be a clear mandate in the regulation that the EMA and national medicines agencies should actively collaborate with the manufacturers of the medicines to avoid duplication of work, under the coordination of the European Commission. This coordination is needed in times of major cross-border health crisis and two-way communication should be maintained more generally. The industry is able to support the regulatory bodies in securing the supply chains and allocation of medicines in states with elevated demand for the benefit of the patients. The COVID-19 also crisis showed us, that there is a need for greater regulatory flexibility, and this should be clearly stated in the regulation – for both EMA and national agencies. We should also underline that the industry dialogue with the Health and Industry Commissioners was important to rapidly solve the numerous problems that arose during the COVID-19 Pandemic.
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