The Right Time for Portugal-Born Pharma Projects to Step-Up to Maturity

November 27, 2019 by Ivan Lafayette (SMIS) & Miguel Lucio (MIS) , ProPharma Group

The Portuguese pharma industry has developed into a market of national and international products using local manufacturing. Learn how outsourcing to service providers can support continued growth.

With a long history of over a century, the Portuguese Pharmaceutical Industry has slowly developed from a rudimentary presence of a limited portfolio of pharmaceutical specialties[1] (early 20th century) into a market of national and international produces of local manufacturing[2]. It has now reached an ambivalent existence where public efforts and private investments have indeed reinforced knowledge, qualifications and R&D entrepreneurialism in the country; but conversely it is still incapable of firming up the national platforms towards greater competitiveness at a global scale.

The changing force leading to the maturity of the industry was definitely marked by Portugal joining the European Union, where country and strategies were later muscularly influenced by the Single Market and the European currency. Consequently, new experiences were rapidly absorbed, and these have erupted reluctant national projects into embryonic companies with a more globalised predisposition. Almost unknowingly and surreptitiously, a tripartite stratagem was assumed by the different Portugal-born companies in terms of their own organics and strategies, i.e., some focused on the production and marketing of multinational innovative pharmaceuticals[3] whereas others embarked on producing for third parties,[4]or immersed themselves into a commercial novelty – the production of generics[5].

It’s undeniable that, for the Portuguese pharmaceutical industry, the 90’s were a lively decade strongly influenced by European directives and projects intended to modernise and restructure the country’s industrial, social and economical fabrics. Progressively, the 2000’s showed a clear investment tendency of foreign companies in acquiring important Portuguese industrial groups[6]. Concurrently and following a trend that had been initiated in the 90’s there was an upsurge of laboratories dedicated to biopharmaceuticals[7].

It is irrefutable that the conception of the European Medicine Agency (EMA) (created in 1990 and brainstormed in Lisbon) helped seed the roots for mutating traditional approaches towards a maturing of the national pharmaceutical services, regulators and regulations.

The creation of:

  • the Basic Health Law (‘Lei de Bases da Saúde’ 1990);
  • the Medicine’s Statute (Decree-Law no. 72/91);
  • the National Pharmacovigilance System (1992);
  • the National Health Service Statute (1993);
  • and Infarmed – the National Authority of Medicines and Health Products (1993), seen by many European counterparts as an example of innovativeness and regulatory acumen;

are perfect examples of a positive paradigm change.

In June 28th 2001, the Ministers’ Council Resolution considered the Pharmaceutical Industry as STRATEGICAL for the Portuguese nation. Nevertheless there are still many recognisable challenges as per several key opinion leaders:

  • it is deemed necessary the creation of balance between health costs, investigation costs and financing costs;
  • price liberalisation and marketing margins,
  • the opening up of new distribution channels,
  • the debating on drug naming standards
  • and the discussing of a treacherous inflow of over-the-counter and online pharmaceutical products.

Nevertheless, the traditional manufacturing and distribution[8] that marked the 90s had undoubtedly blossomed to the new millennium welcoming several international renowned pharmaceutical laboratories[9] into the country.

In 2009 the Portuguese Pharmaceutical Industry had met its proudest moment, consummated when the EMA approved and licensed the international marketing of the very first medicine product originating from Portugal[10]. Since then, numerous other pipeline molecules are now under investigation and have triggered the upsurge of many start-ups and pharmaceutical companies[11] focused on biotechnological innovation and investigation. Nevertheless, this new stage is deemed critical for the industry and encompasses a real test to its maturity. The traditionally idiosyncratic agents find themselves constrained in a peripheral market claiming for expanded boarders and widened scope. The Portuguese pharmaceutical companies must immediately learn from international examples where merges and acquisitions between companies with uneven dimensions, but similar growth visions, take place on a common basis; and from the partnering up with key experienced outsourcing, to overcome endemic weaknesses. Any Portuguese pharmaceutical company willing to embark in a successful globalised venture is required to prepare the future with strong foundations, by associating to and outsourcing from service providers with panoply of interlinked domains and certified experience. Outsourcing from providers, like ProPharma Group, with services tailored to peculiar needs of niche-markets incapable of stretching constrained budgets. These service providers are well prepared to offer a range of dynamic, synergistic and adaptable solutions that are typically apanage of the strongest industry players; services that are now designed to quickly adapt to any market, big or small, at a fully globalised standpoint.

 

REFERENCES

[1] e.g., Companhia Portuguesa de Higiene, 1891; Bayer, 1909, one of the 1st foreign pharma companies to be established in Portugal.

[2] e.g., Grupo Luso—Fármaco that is presently known as Lusomedicamenta and that is dedicated to producing to third parties. And also Tecnifar that focuses essentially on the marketing of some own brands and multinational licenses. The second one is still active in the production and marketing of pharmaceuticals, however of a substantially reduced dimension.

[3] e.g., Bial and Medinfar.

[4] e.g., Laboratórios Azevedos and Iberfar.

[5] e.g., Bluepharma (founded in 2001), Ciclum Farma (founded in 2002), Generis (founded in 2001), ToLife (founded in 2003), Farmoz (founded in 1995 and that in 2002 started marketing as Tecnimede and Basi).

[6] e.g., Fresenus acquired Labesfal in 2004; the Laboratórios JABA was acquired by the Recordati in 2006.

[7] e.g., Genibet Biopharmaceuticals, SA; Gilead Sciences (formerly Nexstar Farmacêutica), Celgene Portugal,  Biogen Idec Portugal, Ecbio – Investigation and Development in Biotechnology (founded in 1999 and that started its own R&D laboratory in 2003), Technophage, Cell2B, and some startups like Luzitin (2010) and Biotecnol, Korangi – Produtos Farmacêuticos, Lda., and the CPCH – Companhia Portuguesa Consumer Health.

[8] e.g., Sofarimex focused on producing for important international third-parties such as Sanofi-Aventis, Novartis, GlaxoSmithKline and Pfizer, and with a portfolio of over 650 products where 75% of these were actually exported to global destinations. Or even Distrifarma, founded in 1993 and that was a very strong wholesaler based in Portugal.

[9] e.g., Germed Portugal (2004), Teva Portugal (2004), Pharmakern Portugal (2005), Mylan Portugal (2008) and the pharmaceutical societies Alfa Wassermann, Bene Farmacêutica, Codilab, Covidien, Diasorin Ibéria, Eisai Farmacêutica, Isdin – Laboratório Farmacêutico, Kironfarma – Produtos Farmacêuticos, Lda., Laboratórios Galderma, SA, Lundbeck Portugal, Medac Portugal, Norgine Portugal Farmacêutica, Phadia, Reckitt Benckiser Healthcare, Smith & Nephew, Takeda – Farmacêuticos Portugal, Lda., Vetoquinol, ViiVHIV Healthcare e Virbac de Portugal – Laboratórios, Lda., later on at around 2012 Beckman Coulter, BSG Pharmaceuticals, Ferrer Hospitalar, Stago Portugal and Zoetis Portugal, Lda.

[10] Owned by Bial, a company founded in 1924 by Álvaro Portela saw the EMA approve the marketing license of Zebinix (an antiepileptic).

[11] e.g., Technophage, Luzitin, Cell2B and Biotecnol.

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