EU pharmaceutical legislation must support a competitive off-patent industry to deliver equitable access to medicines

Strong support for new measures to protect patient access to medicines in Northern Ireland

Biosimilar medicines have delivered 18BN€ total savings for Europe but more action needed to translate this potential into patient access and sustainable health

Commission study highlights market framework conditions are main driver for medicines shortages

Access to essential medicines threatened by combination of increasing inflation and potential further price cuts in EU countries

European Parliament report calls for increased use of off-patent medicines to improve patient access

The EU must stop the offshoring of essential medicines manufacturing investments

Adjustments to IP framework needed to improve access to medicines in Europe

Access to generic and biosimilar medicines can be improved with coherent proposals for IP and pharmaceutical reform in Europe that encourage Day 1 launch.  

This has been echoed in the recent European Parliament report, which supports finetuning the IP system towards higher quality and timely access to generic and biosimilar medicines. 

This includes the timely evaluation of the SPC manufacturing waiver that entered into force in July 2019 and is expected to start producing effects in the second half of 2022. The industry takes very seriously the review that the Commission is going to conduct in 2024 to assess whether the limitations and conditions introduced in the legislation effectively allow companies to achieve the stated objectives. 

Unjustified delays to generic and biosimilar competition after IP expiry are against the objectives of the current pharmaceutical reform and do not reflect the fundamental principles according to which the pharmaceutical system is designed in Europe“, said Sergio Napolitano, General Counsel at Medicines for Europe. “For this reason, it is finally time to ban patent linkage in Europe, give effect to the long-standing objective to enlarge the Bolar exemption and tackle the misuses of divisional patents that unduly extend monopolies and delay access to generic and biosimilar medicines 

These issues will be discussed by representatives of Medicines for Europe, the European Commission and the European Patent Office at a webinar on 16 November. For more information, see here https://www.medicinesforeurope.com/events/lac21/  

 

Medicines for Europe 

Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.   

Access to medicines critical in European Parliament vote on EU IP action plan

The European Parliament Own Initiative Report on an intellectual property action plan is an important step to support the EU’s recovery and resilience following the pandemic and on equitable access to medicine.

 

The report outlines critical policies to address weaknesses in the current system such as

 

  • Stopping abuses of divisional patent applications that artificially extend the enforceable life of patents and block timely access to generic and biosimilar medicines.
  • Banning patent linkages in Europe that systematically delay generic and biosimilar market entry by linking regulatory decisions to the existence of civil patent rights. This is incompatible with the rationale of the EU pharmaceutical system.
  • Revising the Bolar exemption, to allow immediate generic and biosimilar market entry at IP expiry.
  • Assessing the impact of a unitary supplementary protection certificate on timely competition from generic and biosimilar entry. This is clearly driven by the need to ensure that new IP mechanisms do not undermine equitable access to medicine in Europe and that IP titles (and their regulatory extensions) are granted in a transparent and accountable way.

 

The European Parliament has clearly voted for a strong and fair IP system by underlining the importance of timely generic and biosimilar medicine competition. The misuse of divisional patents, the need to enlarge the scope of bolar to include API and all regulatory and administrative steps, and the long overdue ban anti-competitive patent linkage are well known problems that the Commission should address in the IP Action Plan. The Parliament has voted; the Commission must act.”, said Adrian van den Hoven, Director General at Medicines for Europe.

 

Medicines for Europe

Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.

European Commission pilot project on repurposing brings value added innovation to life

Innovation on existing, well-known molecules through repurposing can deliver huge benefits for patients and address unmet medical needs sustainably. Today the European Commission Safe and Timely Access to Medicines for Patients (STAMP) expert group, established in 2015 has launched a project to assist bringing value added repurposing to life.  

Repurposing has shown its value during COVID-19, where existing medicines were used to treat very sick patients. Repurposing, likely in combination with important medicines reformulation, has huge potential to treat rare diseases and cancers.  

The STAMP pilot project will connect academic researchers with medicine regulatory agencies for early scientific advice on repurposing projects. This will be instrumental to generate a robust data package to translate research into to medicines access for patients.  

This pilot project is a great first step to support clinical research projects on existing molecules and it must become a part of a broader sustainable innovation ecosystem for off-patent medicine. To translate clinical research into access to medicines, there should be quick and simple regulatory steps to allow pharmaceutical manufacturers to bring new indications on label and to facilitate patient-centric design for new treatments. This may include reformulation, new strengths or adaptation for specific patient groups (i.e. paediatric populations). These investments must also be recognised in pricing and reimbursement policies to make access a reality for all patients.    

Medicines for Europe is a dedicated partner in the STAMP expert group and will facilitate the cooperation between researchers and pharmaceutical manufacturers  

For more information on the work of the STAMP expert group, see https://ec.europa.eu/health/documents/pharmaceutical-committee/stamp_en  

For more information on the pilot project, see https://www.ema.europa.eu/en/news/repurposing-authorised-medicines-pilot-support-not-profit-organisations-academia  

Medicines for Europe 

Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.