There have been more calls this month to tighten regulations on pharmaceutical ingredient suppliers in the wake of the recent safety concerns emanating from low-cost regions such as China and India. However, despite having recently established a dedicated 'China Taskforce', a major EU chemicals consortium insists that it has nothing against the region or its manufacturers.
At a meeting during last week's CPhI conference in Milan, representatives from the European Fine Chemicals Group (EFCG), a body representing almost 50 chemical firms across Europe, spoke of the group's newly introduced China-focused council, the result of increased interest among manufacturers in taking advantage of this emerging low-cost region. Recent concerns regarding the safety and quality of products emanating from Asia have led to high-profile recalls and much publicised criticism of Asian suppliers and manufacturers. However, the EFCG's China taskforce has not been assembled as a body interested in perpetuating these criticisms of the Asian market, but rather the complete reverse. The actions of some organisations that play on the emotions of consumers and scaremonger to damage the reputation of the Chinese manufacturing sector are "not at all constructive" in the eyes of the EFCG task force, and serve to further sully the waters between manufacturing regions. "If you dig deep down, very often you either have European traders involved, or you have heads of purchasing that are so aggressive in getting 'cheap' that people will cut corners," said member of the EFCG's China taskforce and Hovione CEO, Guy Villax. "The attentive observer will see that China has moved forward by leaps and bounds and has tried very very hard to improve its standards." The Chinese regulators, perhaps spurred on by bad press in the West, have indeed surged forward with new requirements so much so that the Chinese regulatory conditions now go well beyond those in Europe, said Villax. Active ingredients manufactured in Europe but destined for markets outside the region do not in fact need to comply with European laws - the precise issue there has been so much finger-pointing about over in Europe towards Chinese counterparts. "[Chinese manufacturers] weren't required to meet the laws so weren't in a non-compliance situation," said Villax.
"Of course somewhere along the line someone has misrepresented the standard or the quality of the product. We have had information from China that some traders will request producers to make API, and to leave the label blank so that someone can add a [brand] label. "And China has fixed this, Europe hasn't." Establishing a set system across Europe of course has its own set of challenges. With 27 countries to contend with and currently no common procedure between all member states, there is no dedicated system in place to tell customs to stop imports and no set course of action for all countries to follow. With Asia playing an ever-increasing role in the sourcing of pharmaceutical products and manufacturing activities for European companies, it is understandable that EU bodies want to improve relations between the two regions and help ensure that substandard products do not get released onto the market. "We're not really concerned with companies that are doing their best and need to improve their compliance," said Villax of the focus of the new China taskforce. "We're really looking to make sure that the market is not affected by companies for whom non-compliance is a strategy." Villax' aim is to establish relationships with like-minded bodies over in China, and promote an understanding that ensures it is facts that drive opinion and decisions, rather than emotive outbursts from organisations with an agenda. The last thing that the EFCG wants is for it to seem as though the taskforce has been established to pick holes in the Chinese manufacturing industry or perpetuate the conception that there is a lower cost/lower quality pay-off by sourcing products from the region.
"We are not anti-Asia," Villax stated emphatically. "We think there are some great companies in Asia and we also know that there are some lousy companies in Europe. What we want to make sure is that [companies] that are sub-standard are not allowed to offer product." With Chinese and Indian companies heavily represented at this year's CPhI trade show, the prominence of these lower cost regions in the pharmaceutical manufacturing industry is increasingly apparent.
Rather than finger-pointing and criticising as some bodies have been wont to do, the EFCG has at least recognised that this trend is unlikely to slow in the near future, and by establishing its taskforce has taken the decision to look forward and establish a means of easing the integration of this burgeoning region into the European manufacturing scene.