Ensuring regulatory compliance under normal circumstances can be difficult. But conditions are anything but normal in the city of Aleppo, Syria lately, as Syrian government forces clash violently with a populist uprising, forcing the closure of numerous pharmaceutical manufacturers based out of the war-torn city.
The World Health Organization (WHO) on 7 August said the Syrian pharmaceutical sector is in shambles as a result of the fighting.
"Syria was producing 90% of its medicines and drugs locally," before the start of the conflict, said Tarik Jasarevic, a spokesman for WHO. "Now, with the insecurity, availability of raw materials, increased fuel costs and sanction, this production is being slowed down."
"The impact of this situation is of course devastating for people who need drugs on a daily basis, people with chronic conditions, people with mental health situations," continued Jasarevic. "And also for people who are on antibiotics to prevent infections when being treated for conflict-related injuries."
Combined with international sanctions on Syrian exports, the entire pharmaceutical sector could face an arduous recovery process even if fighting were resolved shortly.
An Italian Precedent
One of the closest parallels to the situation may be that of Italy, which recently suffered a series of devastating earthquakes in Mirandola. The quakes leveled billions of dollars in infrastructure and private businesses in the region where much of the country's medical device industry is based.
As with Italy, companies in Syria will be faced with a number of difficult choices: whether to demolish or repair a factory, how and when to schedule new regulatory inspections, how to re-train staff and replace those who might have died or fled the country and how to bring the facility back into compliance.
The choices are not without their own regulatory complications. In some regulatory regimes, the choice to tear down and rebuild a factory would necessitate an extensive inspection before its products are allowed to re-enter the market. Companies able to repair or renovate parts of a damaged manufacturing facility might only be subject to less-exhaustive inspection.
In the face of such challenges, many manufacturers-as in Italy-may ultimately choose to permanently shutter the facilities and move their operations elsewhere to avoid the regulatory headaches and export sanctions.