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APOGEN presents five Recommendations for the Presidency of the Council of the European Union

Promote knowledge about generic and biosimilar medicines and develop competitive and sustainable market policies. These are some of the recommendations presented in the e-conference “Value in Health – the Commitment of Generic and Biosimilar Medicines”.

The meeting, promoted by APOGEN – Portuguese Association of Generic and Biosimilar Medicines, brought together several specialists around the debate on the value in health and also served for the presentation of five Recommendations for the Presidency of the Council of the European Union 2021.

Over the past nine years, the savings generated by generic drugs on an outpatient basis have increased steadily. However, growth did not happen “consistently“, despite being “through generic and biosimilar medicines that situations of true vertical and horizontal equity can be created”, with the resources released making “an important contribution to the National Health Service. Health (SNS) and for families so that they can finance the acquisition of other goods and services ”, said João Madeira, President of APOGEN.

Despite a safety and efficacy widely proven and confirmed, and having the SNS, as reinforced by several of the specialists present at the meeting, a sustainability problem, “we still do not use the effects of generics and biosimilars at full power”, confirms Hélder Mota Filipe, Associate Professor at the Faculty of Pharmacy, University of Lisbon, who was responsible for presenting the Recommendations, which are nothing more than “considerations about the role that these drugs can play, not only at national level, but also at European level”.

Recommendations for the Presidency of the Council of the European Union 2021:

  • Promote knowledge about generic and biosimilar medicines through the involvement of strategic partners, namely health professionals, patients, and policymakers, promoting informed self-management of health processes and improving the population’s health levels;
  • Integrate, in the prescription systems, updated information to support the decision on the availability of generic or biosimilar medicines, promoting a more rational and cost-effective prescription;
  • Evaluate clinical guidance standards and algorithms to support the clinical decision as soon as a biosimilar or generic drug is available and promote its adoption, whenever justified from a therapeutic point of view, improving the results for the patient and/or promoting gains efficiency for the health systems, namely for the NHS. It is also important that, as soon as there are generics or biosimilars available, that clinical guidelines can be almost immediately reviewed, adjusting them to these realities;
  • Foster predictability and competition on the part of procurement systems, guaranteeing the full execution of tenders, the reopening of procurement processes after the entry into the market of a first generic or biosimilar medicine and that the award deadlines incorporate the lead time of manufacturing;
  • Develop competitive and sustainable market policies that take into account the economic viability of suppliers of generic and biosimilar medicines and the role they play in the long-term sustainability and preservation of the NHS.

During the meeting, much was said about oncology, with Rosa Giuliani, an oncologist and responsible for Public Policy for the European Society of Medical Oncology (ESMO), warning that, in this area, “there are essential drugs that, however, are not available to many patients.

There has been a lot of discussion about biosimilars, but for me, as a health professional, what is more important is that biosimilar medicines will allow increased access and increased access to important treatment options, contributing to the sustainability of cancer treatment”, which, as confirmed by Rui Santos Ivo, president of Infarmed, “represents a very high burden on health systems, with the progressive loss of patents creating a significant savings potential”.

And the voice of João Madeira also spoke of the importance of using digital tools to increase access to medicines, with quality and without an increase in spending.

The president of APOGEN suggested, in this sense, the creation “of a simplex for the medicine area, as well as “the more intensive use of prescription software, the adoption of electronic computer leaflets, the reduction of expenditure through the elimination of packaging test”, among others.

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