From Mr M. Galea and Ms A. Mckenna

We refer to the article with the above title (TMIS, 16 January).

Malta Enterprises’ contribution to the Journal of Generic Medicines is entitled – “The Manufacture of Generic Pharmaceuticals in Malta – A First Step” and it clearly asserts that the expansion of the generic pharmaceutical manufacturing sector is but the initial phase of a strategy that envisages Malta as a Mediterranean health care centre of excellence.

A flourishing generics industry should provide the basis for R&D pharma initiatives and eventually an entrée to the large innovative companies.

If Malta had a competitive advantage to offer the huge pharma companies, Malta Enterprise would certainly have already approached the Pfizers of this world.

Moreover, in no way does the absence of a competitive advantage stem from any weaknesses in Malta’s patent legislation. Indeed our laws protecting intellectual property date back to the 1960s, making Malta among the earliest of the EU member States in this regard. With the provisions introduced by the Patents and Designs Act of 2002 our intellectual property legislation is more than robust.

The innovative pharmaceutical companies have a strong presence in the UK, Ireland, Scandinavia and other EU countries where they can take advantage of economies of scale, where there is ample R&D funding and where there is a strong tradition of advanced research in industrial pharmacy and analytical chemistry within the universities. At present Malta can offer none of these advantages.

Malta’s competitive advantage for the manufacture of generic pharmaceuticals most definitely does not arise from “a shaky patent structure”. And the fact that Malta Enterprise is concerned to expand this sector in no way implies that the Corporation is opposed to the strengthening of intellectual property rights in Malta.

For the next few years only, Malta’s competitive advantage for manufacturers of generics hinges largely on the fact that historically the “well-heeled brand name manufacturers” overlooked our islands and did not register their innovative medicines (nor New Chemical Entities – NCEs) with our patents office. If they were not concerned to protect their innovations in Malta, how more interested would they have been in setting up a manufacturing base here?

Is it not Malta Enterprises’ task to exploit every single competitive advantage in the country’s best economic interests? With the inflow of investment in this sector, Malta Enterprise has been working with the ETC and the pharma sector of the FOI to introduce courses at MCAST and the university to ensure that the skills required by the industry are available locally. Obviously such competencies are those that would be recruited by the innovative companies as well as those that produce generics.

The Malta Independent on Sunday article overlooks the fact that the local generic manufacturers do take on production contracts for the large ethical as well as for generic companies. As such, the big brand holders are being introduced indirectly to Malta’s high production standards.

In addition, while the generic pharmaceutical manufacturing sector is thriving in India, many of the successful companies have diversified into the production of innovative drugs and investing ever-increasing sums in R&D.

On the other hand, the famous block buster companies are now faltering with fewer innovations in the pipeline and the rising costs of R&D. Governments of the major markets for the branded pharmaceuticals are anxious to reduce their burgeoning healthcare costs due to ageing populations and heartily support the introduction of generics after patent expiry.

Not surprisingly, in this context the ethical companies have themselves diversified into generics. In such circumstances the analogy of the “generic vultures swooping on to the market of the brand holders” is nothing but preposterous. Indeed, the European Union itself is introducing the Bolar provisions into its legislation to encourage the production of generics in its member States.

This aside, the author’s reference to “crumbs” amounts to 18 projects (12 operating and six with contractual obligations with Malta Enterprise) that will invest in Malta Lm60 million in the next three years creating jobs for over 800 people.

Is this something to be snubbed?

And does this not prove that the figure of “$1 million for the setting up of generic production” is way off the mark.

The author erroneously refers to the “possible accession of Malta to the European Patent Convention (EPC) that McKenna and Galea lament”. On the contrary, Malta Enterprise publicly acknowledges the inevitability of Malta’s accession and this is underscored by a proper reading of the Corporation’s article in the Journal.

With respect – the author’s lament that “Malta Enterprise goes for the crumbs” would be best substantiated by a coherent alternative strategy aimed at attracting the big pharma companies to locate here thus spelling out clearly the advantages Malta has to offer.

Malta Enterprise is a publicly funded institution. It has the responsibility to ensure that public funds are spent such as to maximize economic returns in the most cost effective ways possible. Thus the Corporation’s strategies have to be focused, realizable and effective within a clear long-term vision… where pragmatism and realism are the order of the day.

Mario Galea

Head – Niche Area Development

Anne McKenna

Coordinator – Business Development

Malta Enterprise