THE MARKET

  • Very fragmented sector with about 1000 GMP companies plus many others without GMP, with frankly hard competition for this reason.
  • Approach to the customer has very different manifestations ranging from competitive price up to the minimum "time to market", delivery, consistency of quality assurance, the degree of compliance with the regulatory aspects, the endorsement of a in-depth study of the status of the patent etc.
  • The leadership in Europe belongs to Spain and Italy.
  • The subsector of pharmaceutical raw materials in Spain is one of a greater significance industrial specialization in organic chemistry, being represented by the producers of active pharmaceutical and intermediate principles by synthesis, fermentation and / or biotechnology, located mostly in Catalonia. It also integrates the list of products and services: intermediates, "comodities", "contract manufacturing", "custom synthesis", elaboration of DMFs, COS, cooperation for pharmaceutical registers...
  • The Spanish production represents approximately 5% of the world production of these raw materials with a turnover exceeding 2,200 million euros. 80% of the mentioned production is exported.
  • Spanish factories have grown under the protection of regulated markets such as the United States, the European Union and Japan that seek quality assurance above the prices of non-approved manufacturers. Favorable situations in Industrial Property have also been essential factors for such development.

The Patent

  • In March 1986 the new Spanish Patent Law was published, which was coming into force on October 7, 1992, gathering legal figures that reinforced the protection of procedural patents while introducing the patentability of pharmaceutical products.
  • The new Law introduced among other modifications:
    • the Information about the State of the Technique,
    • the reversal of the burden of proof,
    • The fact-checking diligence
  • At the end of the 80s another figure appears, the Supplementary Protection Certificate (SPC) that adds to the patent a time equivalent to the one which elapses between the date of application for the patent and the first Marketing Authorization in the European Community, subtracting five years. The SPC can not last more than five years. In Spain, Greece and Portugal came into force in January 1998.
  • Subsequently, a law similar to the American "Bolar provision" was introduced that opened a new way in Spain to allow acts performed for experimental purposes to be considered in accordance with the patent right.

The Quality

  • Guaranteed control over the process, consistent results, existence of prevention methods, deviation management procedures to prevent recurrences, traceability mechanisms...
  • The keys: continuous improvement, audits and proactive attitude that is ahead of the potential productive problems.
  • the harmonized ICH standards for the first time obtaining an internationally harmonized GMP guide, promoting the mutual recognition of GMPs in the manufacturers of the markets of the ICH region and facilitating the appropriate inspections of the headquarters and processes.
  • US generic culture already impregnates Europe and Spanish manufacturers to consolidate in regulated markets based on the requirements and inspections of the FDA: GMPs, GLPs, GDP's, BACPAC, GAM...

The Sustainability

  • Our companies have been able to overcome all the barriers with the consequent technological adaptation and precise investments.
  • Also overcame technical barriers in the style of EINECS and REACH that are qualifying our sector as the only way to avoid unfair competition.
  • Environmental pressure, years ago a negative factor for our industry, has also become a deterrent for those who create situations of comparative harm.
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