Joint information day OEPM, AESEG and AFAQUIM

  • Next July 2nd, the exception for the SPC waiver comes into force to respond to the competitive disadvantage of generic medicines manufacturers established in the EU compared to third country producers.
  • The SPC waiver will allow European generic medicines and active pharmaceutical ingredient companies to manufacture for export to third countries where there was no patent protection or it had expired, and also to store and export to EU countries as soon as the protection period ends.

Madrid, March 16th, 2022. the Spanish Patent and Trademark Office (OEPM), the Spanish Association of Generic Medicines (AESEG) and the Spanish Association of Manufacturers of Fine Chemical Products, Active Pharmaceutical Ingredients and their intermediates (AFAQUIM) have jointly organized an information day on the application of the exception for Supplementary Protection Certificates (SPC waiver) aimed at industrial property pharmaceutical industry of generic medicines and active pharmaceutical ingredients professionals given the application of this measure on July 2nd.

The event took place this Tuesday at OEPM’s headquarters in Madrid and was presented by its director, José Antonio Gil Celedonio, who was in charge of inaugurating the session during which this change was analyzed, among other issues, by experts in this field, including what is the SCP waiver and the obligations it implies for manufacturers.

The event hosted two round tables. The first of them, “An approach to the SPC waiver”, was moderated by Ángel Luis Rodríguez de la Cuerda, general secretary of AESEG and counted with the interventions of Soledad Cabezón, former MEP for PSOE and Miguel Vidal-Quadras, patent issues advisor for AESEG.

Mila Jové de Santisteban, AFAQUIM’s general director, moderated the second panel discussion on “Manufacturer’s obligations” in which intervened Beatriz Díaz de Escauriaza, head of Legal and Intellectual Property of Insud Pharma; Gabriel González Limas, OEPM’s head of Chemical Patents Area and Oriol Ramón, also patent advisor for AESEG.

The session was closed OEPM’s Department of Patents and Technological Innovation director, María José de Concepción Sánchez.

About the SCP waiver

The SPC waiver is an update to EU regulations that will allow European manufacturers to compete with third country producers who are currently in an advantageous position.

Almost three decades ago the EU created the SPC (Supplementary Protection Certificate), a right that extended medicine patents by 5 years. The SPC does not exist in most countries of the world. This additional exclusive patent in Europe has damaged the European generic medicines industry, which cannot manufacture and store before the SPC expires while its non-European competitors can.

The SPC waiver will allow European generic and active pharmaceutical companies to manufacture for export to other countries where patent protection does not exist or has already expired, and also to store and export in Europe as soon as the monopoly granted by supplementary protection certificates ends.

Patients, industry and economy, main beneficiaries of the SPC waiver

The SPC waiver will benefit the Spanish generic medicines industry, one of the most important worldwide since 5% of the medicines in the planet are manufactured in Spain. Likewise, 7 out of 10 generic medicines that are marketed in Spain are produced in our country. The SPC waiver will benefit Spanish companies that will recover the competitiveness they lost when the Supplementary Protection Certificate was created.

Patients who will have safe, effective and quality medicines manufactured in Europe at their fingertips as soon as the SPC monopoly expires will also benefit. Likewise, our country’s economy, will gain through the creation of qualified jobs, the growth of our pharmaceutical industry and the reduction of pharmaceutical spending.

About the OEPM

The Spanish Patent and Trademark Office (OEPM) is an independent Body of the State Administration that promotes and supports technological and economic development by granting legal protection to the different types of industrial property through the granting of patents and utility models (inventions); industrial designs (shape creations); trademarks and trade names (distinctive signs) and titles of protection of topographies of semiconductor products. It also disseminates information on the different forms of industrial property protection. At the international level, the OEPM is responsible for representing Spain in the various international fora and organizations that deal with industrial and intellectual property. Learn more at https://www.oepm.es @OEPM_es

About AESEG (Spanish Association of Generic Medicines)

Founded in Barcelona in 1998, AESEG is the business association of the pharmaceutical industry of generic medicines in Spain and the main qualified business partner in this area. AESEG promotes the knowledge and rational use of generic medicines in our country, with the double objective of ensuring that Generic Pharmaceutical Equivalents (EFG) represent a mechanism for containing pharmaceutical spending and, at the same time, achieving the development of a true culture of generic medicine in Spain. AESEG is a member of Medicines for Europe association, which represents the generic, biosimilar and value-added medicines industries across Europe. Learn more at https://www.aeseg.es/es/ and https://www.engenerico.com/ On Twitter @AESEG_genericos and @engenerico

About AFAQUIM

Manufacturers of Active Ingredients and pharmaceutical intermediates in Spain has a turnover that exceeds 2,400 million Euros and exports of around 83%. Despite global competition in prices, especially from Asian countries, the sector has responded with the highest quality and safety of its products, manufacturing under the strictest global standards such as GMP legislation, and maintains a constant line of growth of more than 15% per year. Spain is the second European country in importance in the production of pharmaceutical active ingredients, well above its industrial position in all nations. AFAQUIM has 33 member companies, some integrated into international groups and most of them independent manufacturers. Learn more at https://afaquim.org/ @afaquim_asoc

Pie de foto de familia, de izquierda a derecha:

Oriol Ramon, asesor en materia de patentes de AESEG.

Beatriz Díaz de Escauriaza, Head of IP Legal en Insud Pharma.

María José de Concepción Sánchez, directora del departamento de Patentes e Innovación Tecnológica de la OEPM.

Mila Jové de Santisteban, directora general de AFAQUIM.

José Antonio Gil Celedonio, director de la OEPM.

Ángel Luis Rodríguez de la Cuerda, secretario general de AESEG.

Soledad Cabezón, exeurodiputada por el PSOE.

Gabriel González Limas, jefe del Área de Patentes Químicas de la OEPM.

Miguel Vidal-Quadras, asesor en materia de patentes de AESEG.

Para más información:

OEPM

Ana Cariño Fraisse

prensa@oepm.es

+34 913 495 502

AESEG

Marisol Atencio Álvarez

matencio@aeseg.es

+34 915 721 262

AFAQUIM

Ángela López Berrocal

alopez@ma3comunicacion.com

+34 918 664 292

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