The EU market is the second largest pharmaceutical market in the world, with a 27% share, right behind the US market. The pharmaceutical sector is one of the sectors with the largest surplus in the commodity exchange in the EU with around 80 billion euro (information for 2010). This is the technological sector with the highest added value per employee (1.7% employees in the sector; 5.5% of added value). It is predicted that the market might increase by 2-5% annually from 2011 until 2016.
On the 1st of July, this market will be joined by the Croatian pharmaceutical industry, which has been preparing for this step since the definition of negotiation chapters in 2005.
Dunja Siuc Valković, MD, Business Development Director at JGL, who has actively participated in the negotiation work groups, emphasizes today that good preparation and competitiveness are the key preconditions for business operation on the EU markets. In the recent years, JGL has made significant investments, exports and employed new people; it has a core of knowledge and capabilities, technologically demanding production with a high added value and extremely developed technological platform. There are also high entry barriers with regard to project development, registration and GMP certification. Besides proving its competitiveness through its quality and the possibilities of price positioning, the company’s operation is fully in accordance with the EU norms, with all the necessary certificates. Furthermore, the company’s reputation as a subject which can set an example for others as the developer of domestic economy was further supported through its acknowledgement by the Croatian president Ivo Josipović this week. JGL was awarded the Charter of the Republic of Croatia for an outstanding economic contribution and the encouragement of Croatia’s social development.
Seeing as this company situated in Rijeka has had a subsidiary on the Slovenian market since 1992, it can be argued that the process of adaptation to the EU requirements has already been accomplished to a degree. Besides, due to its direct distribution of products, JGL already conducts its business activities in Germany, Portugal, Great Britain and Hungary. Indirect presence on the markets of Italy, Belgium, France and other EU countries is achieved with the help of partners, i.e. contract manufacturing.
According to Dunja Siuc Valković, Croatia’s acceptance in the European family will be reflected not only in the improved overall business, but also in the global perception of the Croatian industry. Next to American, the EU pharmaceutical regulations are known as one of the strictest, and there is a trend toward global regulatory harmonization.
Besides innovations in the field of technology, design, different marketing strategies and tactics, success will certainly be aided by innovative product formulations. JGL is particularly proud of its brands Aqua Maris and Meralys, which have received awards for innovation at the recent innovation exhibition in the USA. The significance of gold medals for the Aqua Maris nasal cleaning system and Meralys nasal spray is even bigger seeing as the exhibition hosted 1800 innovative products from the USA and 22 countries from all over the world.
“Meralys is a medicine registered through a DCP procedure on 10 and licensed on 7 markets of the EU, and serves as a proof that investing in knowledge and technological processes can help achieve added value which can be well commercialized. The product is also licensed to a big global partner, which is one of the extremely rare licences that Croatian manufacturers have been able to accomplish as a result of their investment in knowledge,” said Dunja Suic Valković.
Direct experience of business operations, specialized production and technology, a network of partners, a portfolio of products with different legislative categories, enabling the flexibility of entry on the EU markets, developed brands which have already stepped onto the EU market, and fast business processes are seen by JGL as its advantages upon its entry on the EU market.
On 1 July 2013, JGL will enter the last phase of its status as a pharmaceutical manufacturer – by releasing products it will be able to register centralized and decentralized procedures, declare its products by using the label “Made in Europe,” and it will also save significant amounts of money for the distribution of medicines due to unnecessary consignment warehouses. The entry itself will make the company an interesting partner even to those companies that are not part of the European family, in the sense of providing regulatory services. Furthermore, one should not disregard the opportunities that will come in the form of structural and cohesion EU funds in a common European research area, supported by our knowledge, competencies and capacities.
“Besides the EU entry, this year is especially important for JGL seeing as we have started the biggest investment so far, the Pharma Valley complex on Svilno, which will significantly extend our production facilities and improve the existing facilities,” said Dunja Suic Valković.