[Reporter's view] ‘Generic exclusivity' must be improved

As the proposed regulation of the co-biological equivalence test was stopped by the Regulatory Reform Committee, The consigned generics business has revived.

 

On the other hand, companies producing single generics that have claimed to regulate co-biological equivalence testing are concerned.

 

They point out that there are many competitors in the market due to the activation of consigned generics, so there is no advantage of single-developed generics.

 

Since the pharmaceutical industry was divided in half with respect to this regulation, it seems that everyone cannot be satisfied unless a new system is introduced.

 

To this end, the generic exclusivity needs to be improved so that everyone can be satisfied.

 

The generic exclusivity, which was introduced as the Korea-US FTA in 2013, has been collecting opinions from all over the recent improvement plan, but has not progressed.

 

However, it is unlikely that any improvement measures that have been significantly changed .

 

The biggest problem with the current generic exclusivity is that marketing exclusivity has no great benefit.

 

The 9-month monopoly period is also a short period for generics to settle down, and there are many items that receive the generic exclusivity, so it is more than just satisfied with entering the market rather than being a monopoly.

 

Some predicted that if the regulation is enforced, many companies will lose their generic exclusivity.

 

However, with the withdrawal of co-regulation, the consignment system for entering the market is unlikely to be different.

 

Through this regulation, it is predicted that the generic exclusivity will be acquired by a number of contractors with pharmaceutical companies that have successfully developed generics.

 

As competition increases, marketing exclusivity becomes meaningless.

 

In this regard, a plan should be devised so that generic exclusivity can be given only to companies that have overcome patents and developed generic drugs.

 

In order to do that, even if the consignment company does not make a consignment production to the majority, it must create a structure that can benefit from the generic exclusivity to copyright.

 

For example, it is necessary to find a way to extend the period of the right to copyright much more than 9 months a year, or to give preferential prices to the generics.

 

If the ₩10 billion is secured during the period of generic exclusivity, there will be no other company to give profits to others.

 

However, it is difficult for the generic to get ₩1 billion for 9 months.

 

It is necessary to inform the medical institutions the generic exclusivity is the only generics that confronts the original through export preferential support, various tax benefits, and brand support.

 

The MFDS has recently formed a public-private council aimed at strengthening international competitiveness of domestic generics to seek ways to support them.

 

However, it is more difficult for generics that are not treated in the domestic market to have competitiveness overseas.

 

Rather, it is better to grow it in the domestic market so that pharmaceutical companies can make global new drugs with that money.

 

It is difficult to create a competitive generic with a system that cannot take advantage of generics as it is now.

 

It seems that a more innovative support plan is needed.