Regulatory reforms critical to improve patient access to medicines

The ongoing review of the EU pharmaceutical legislation framework is a major opportunity to update the EU regulatory system. Future reforms should focus on a system that delivers meaningful benefits to patients, particularly timely access to medicines supported by efficient regulatory processes, readily accessible information on medicines and better systems to manage medicines shortages.

The off-patent medicines sector accounts for almost 70% of medicines dispensed in Europe, helping to manage the most prevalent chronic diseases including cancer, auto-immune conditions, cardiac disease and diabetes. The regulatory framework must be tailored so that these medicines can readily get to the patients and healthcare professionals who need them.

The upcoming review of the EU pharma legislation should prioritise the following regulatory initiatives:

  • A strong push for European-wide digitalisation, including the creation of an interoperable digital network of medicine agencies. This is essential to enable the quick exchange of regulatory data between medicines agencies and, where relevant, with industry.
  • Simplify and streamline procedures, reducing regulatory burden and costs
  • Prevent the unnecessary and unethical repetition of clinical studies for off-patent medicines by integrating scientific progress, supporting single development, and leveraging international regulatory convergence and cooperation.

 

Speaking at the Medicines for Europe regulatory affairs conference, ad interim President Rebecca Guntern said: “It’s almost impossible to exaggerate the extent to which access to affordable off-patent medicines depends on a fit-for-purpose and fully-digitalised regulatory framework. The proper functioning of this system is absolutely critical, both to get the right medicine to the right patient at the right time today and to ensure the sustainable development of the industry to meet the patient needs of tomorrow.”

The series of regulatory affairs webinars will take place between January 24th and 09th February. For more details, and to register, please visit https://www.medicinesforeurope.com/events/racphv2022/

 

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.

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

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

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

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

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

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

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The EU must stop the offshoring of essential medicines manufacturing investments

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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.

Medicines For Europe