parallel importation is the activity of re-selling pharmaceuticals in another country without the express consent of the company who holds the marketing authorization. This trading activity is driven by the price difference that exists between countries.
There are two main importing forms of medicines.
- One is by agents, who registered the medicines and have responsibility for them.
Agents should trace medicines from buying stage to shipment, delivering and distributing by wholesalers and selling by pharmacies. In addition, they are responsible for safety, quality and efficacy and pharmacovigilance of medicines.
2. Two is by importers.
The main activity of them is supply medicines only. They could import medicines from registered wholesalers in confirmed countries based on its specific regulation. In this form of import, they rely on confirmed countries’ regulations to ensure about safety, quality and efficacy of required medicines.
Generally, registered branded medicine have imported exclusively by specific agents.
branded medicines originators charge lower prices for a medicine in one country than in another, taking into account their market power. This means that a country with limited resources can sometimes afford more of patented medicines by purchasing them in other countries at a lower price and importing them, rather than buying them directly in its domestic market at the higher price.
Many countries’ patent laws dictate that once a patent owner sells its goods in any country, it has no right to control the resale of those goods (so-called “regime of international exhaustion”). In legal terms, the patent owner has “exhausted” its property rights in the product actually sold while it maintains the exclusive right to manufacture the product, but it cannot use its intellectual property rights to prevent resale of those products it sells.
Thus importers could buy a patented medicine in one country at the lower price and then resell the medicine in another country at a price that is higher but still undercuts what the manufacturer is charging for its patented medicine in that country by their agents. – “parallel importing”.
Opponents of parallel importing often claim that parallel importing would support consumer deception and trade in counterfeit goods and pirated goods.
The benefits of parallel imports are:
- Direct reduction in branded medicines price.
- PI can be a complement to price control strategies. It provides health providers strong negotiating leverage with original manufacturers that they cut their prices down.
Parallel import is one of the policies to cut the medicines price these days. It means that you allows the importers to Parallel import some branded medicines.
cons of parallel imports:
- high amount of medicines that have been imported by importers (not agents) are coming from unregulated countries. It means that importers buy medicines from wholesalers in other countries that are not regulated by our government. It makes us worried about safety, quality and efficacy of these medicines. It’s possible to counterfeit medicines are parallel imported to the country via countries of beneficiary’s unregulated market.
Counterfeit medicines are deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can be relevant to both branded and generic medicines. Counterfeit medicines may include products with the correct ingredients but fake packaging, without active ingredients, with insufficient active ingredients or with the wrong ingredients.
2. Lack of enough supervision on route of transportation of medicines in Parallel import (for example those which need cool chain for transportation), medicines might be corrupted and become out of use before their expiry date.
3. Since branded owners don’t accept the responsibility of parallel imported medicines, responsibility for adverse reactions of these medicines is unclear.
It’s not logical to prioritize price and affordability over safety, quality and efficacy.
reference(article from ncbi)
