Turkey: A Promise Restored? - Pharmaceutical Executive

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Turkey: A Promise Restored?


Pharmaceutical Executive


Following EU precedent

There are also continuing problems with Turkey's recognition and enforcement of intellectual property. According to Kemprecos, industry executives view Turkey as seriously behind the rest of Europe in protecting commercially sensitive data. Turkey currently only offers six years' of data exclusivity, and that is dated from the registration of the product in Europe. "This has acted as a drag on investment in the innovative medicines sector," Kemprecos adds, "because it is perceived as yet another important policy area where Turkey is not fully harmonized nor globally competitive."


Pharmaceutical exports from Turkey have steadily risen since 2000
The issue has long been a bone of contention with regard to Turkey's plans for EU accession, negotiations on which began in 2004. But by 2012 the issue of accession itself looked like something of a damp squib. That's not altogether surprising, given the spreading eurozone crisis and the European Union's less-than-inspiring handling of the fiscal and debt crisis in Ireland, Portugal, and Greece. As Murat Yesildere points out, the reason Turkey wanted to join the European Union in the first place was for prosperity, jobs, money—"but that is now wavering." Candan Karabagli, CEO of Turkey's leading pharma company Abdi Ibrahim, adds that the country is resigned to the fact that the rest of Europe doesn't want it to join. Either way, it certainly seems unlikely now that accession will happen before 2020.

Still, there is a consensus that the detailed, chapter by chapter preparations for accession—whether it happens or not—have been good for Turkey. Says Karabagli, the country has been required to "upgrade its democracy, upgrade its human rights, upgrade its regulations." For pharma, the negotiations have meant a strengthening of regulatory infrastructure to protect IP and to conform to international norms on drug safety and manufacturing. In the last decade Turkey has set up more than 20 civil and criminal IPR courts and established an EU-Turkey Working Group on IPR; starting in 2005/2006 Turkish pharma companies began adopting the Common Technical Document (CTD) format for registration, and in 2009 the country adopted the EU directive on good clinical practice (GCP).

Turkey still has a lot of work to do to satisfy the European Union, however. AIFD research last year revealed that the regulatory approval procedure in Turkey—with an average waiting time for drug approval of 772 days—is still a long way behind Europe; the mandated EU timeframe for regulatory approval is set at a maximum 210 days. Accession, says AIFD, would bring things up to EU standards "in terms of openness and accountability of public policies, as well as increasing access to pharmaceutical products."

But Kemprecos believes that the country needn't take the accession route in order to become a global player. Turkey "could adopt or even improve on the best standards in Europe today as part of its competitiveness agenda for the innovative biotechnology and research-based industry," he says. He points to Switzerland, which, like Turkey, isn't a member of the European Union but which has "taken on board the best of Europe in terms of standards, particularly in the regulatory area." As an accession candidate country, Turkey is not tethered to Brussels' agenda or the woes in Europe. "While the country is obligated to implement certain standards, we believe that Ankara retains the kind of policy-making flexibility where Turkey could put in place reforms that could give it a leg up on the global competition."

The problem of the last few years has been a lack of cohesive, holistic thinking around the industry. This was not due to bad intentions, says Kemprecos; rather, a lot of the time governments fail to appreciate the complicated nature of the industry. "The health ministry doesn't necessarily inform the views of the finance ministry, and the finance ministry doesn't appreciate the special taxation concerns of R&D-intensive industries such as the life sciences industry." Candan Karabagli echoes the sense of frustration: "It's a Catch 22; you need to reduce the burden as well as ensure the industry is sustainable. The government listens to us, but the number of things they can do for us is limited."

Yesildere believes, however, that opportunities can arise from the constraints. The recent pricing pressures have "motivated most of the players to be more creative," he says. There are an increased number of new commercial models being implemented. "Companies are exploring different ways of approaching customers, doctors, and key opinion leaders, through digital networks, for example." He cites Abdi Ibrahim as a prime example of a local company that is "eager to go its own way" and launch new initiatives—"not government-led initiatives, but projects supporting their own ambitions."

Indeed, having accepted that growth is difficult in the domestic market, two years ago Abdi Ibrahim established Vision 2021, an initiative aimed at sustaining its leadership in the Turkish market, by, Karabagli says, "adapting and being ahead of the innovation curve." Also key was a new strategy to foster globalization. Karabagli adds: "We would like to be a regional player. We've chosen the immediate area surrounding Turkey, the Middle East, North Africa, and have been developing more business in these countries in order to spread the risk." And in 2010 and 2011 Abdi began exporting to 20 new countries, including Poland, Portugal, France, Italy, Germany, Netherlands, Greece, Korea, and the United Kingdom. While conceding that the price deflation at home is "very challenging and happening a little too quickly for us to keep up with," Karabagli is firm in noting "we have to make our own destiny."


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