Keh (left) and Diong are of the opinion that the impact of TPPA on the local pharmaceutical industry is not as big as expected. Photo: The Star
Increased drug prices has been one of the main concerns related to the Trans-Pacific Partnership Agreement (TPPA) – in Malaysia, as well as in the other 11 countries involved.
Fears that the Intellectual Property section of the agreement would enable medicine patent-holders to maintain their monopoly for a longer period of time have been spreading ever since drafts of the agreement were leaked, beginning in 2013.
This longer period of monopoly would allow patent-holders the freedom to set their own prices without having any generic or biosimilar competition.
This is because similar generic or biosimilar medicines would not be able to register for approval to sell their products if the original patent is still in force.
As the association representing the major pharmaceutical companies manufacturing generics and biosimilars in Malaysia, this was also very much the concern of the Malaysian Organisation of Pharmaceutical Industries (Mopi).
However, after analysing the final text of the TPPA released by the International Trade and Industry Ministry (Miti) on Nov 5, 2015, Mopi president Diong Sing Peng says that the impact on the local pharmaceutical industry is not as big as they expected.
Areas of concern
According to him, the three main items in the agreement that health stakeholders are most concerned about are patent extension, patent linkage and data exclusivity.
“Patent extension occurs when market access is delayed or granting of the patent is delayed,” he says.
In the TPPA, extension of the 20-year patent period – the same as the current patent period in Malaysia – is required if there is “unreasonable delay” of the application process.
This is defined as five years from the point of application or three years after a request for examination of application, whichever is later.
However, the Intellectual Property Corporation of Malaysia’s client charter for granting of patents is 26 months for ordinary submissions.
In addition, Diong notes that the application process in Malaysia operates under a stop-clock system, meaning that if there are any queries or additional material needed from the applicant, the “clock” on the processing is stopped until the matter is resolved.
Therefore, only actual processing time is counted.
“So, that is basically the key contentious issue that people always say will lead to patent extension. Patent extension would then come about because of the inefficiency of the government agency; but, I’m sure, today, our government agencies are quite efficient,” he says.
The second area of concern is patent linkage.
Diong explains that this is where the public fears that the National Pharmaceutical Control Bureau (NPCB) would be compelled to enforce patent protection – rather than the patent-holder itself – once the TPPA is in place.
As this is not currently part of the NPCB’s jurisdiction, Diong opines that they neither have the resources nor expertise to do this.
“Malaysia has negotiated so that they do not have to do enforcement; they will do notification instead,” he explains.
This means that if a company applies for a patent or approval to market a generic or biosimilar drug that has the same composition and effect as one already on file, the NPCB is only required to notify the original patent-holder of the new application.
“It is then a civil law case – a patent law case – between the two parties,” he says.
“There are already existing judicial processes to manage this, so why should NPCB spend extra resources, time, money and training to do this job?” he adds.
Data exclusivity
The final area of concern is data exclusivity.
Malaysia currently provides five years of data exclusivity, from the time of marketing approval, to all approved drugs.
This means that the Health Ministry cannot use the clinical data generated by the original manufacturer – which demonstrates the safety and efficacy of the drug – to approve similar generic drugs.
Under the TPPA, this amount of time would be the same.
In addition, a clause specific to Malaysia requires that drug companies apply for market approval within 18 months of their medicine first entering the market anywhere in the world.
This, says Mopi executive director Keh Song Hock, would help safeguard against any attempts at “evergreening”.
Evergreening is the practice of extending monopoly over certain products through various tactics, including filing for new patents or data exclusivity rights for drugs when the original one is about to expire.
Meanwhile, for biologics, the TPPA provides two options for data exclusivity: eight years and five years with other measures to “provide effective marketing protection”.
These other measures, aimed at delivering “a comparable outcome in the market” as the eight-year protection, are “through other measures, and recognising that market circumstances also contribute to effective market protection”.
Says Diong: “From what we understand from the negotiators, sometimes, these ambiguous words were used partly because all the countries couldn’t agree on the exact terms. Sometimes they do that and work it out later.”
He adds that the most important point for him is the exact time-frame of five years.
And this, according to Miti, is the option the Government intends to take.
Overall, Mopi does not believe the price of medicines will increase if Malaysia signs the TPPA.
In a statement issued on Thursday, the organisation noted that foreign exchange rates, the availability of raw materials that frequently have to be imported, types of competitors and cost of production are among the more important factors affecting the cost of drugs.
And when it comes to public health, the TPPA has a clause noting that the obligations of the agreement do not preclude its signatories from taking appropriate measures to protect public health and promote access to medicines for all.
Miti notes that the agreement allows governments to issue a compulsory license to enable local manufacture of a patented medicine or make use of the “rights of governments” to import patented medicines from different sources at a different price, i.e. cheaper generics or biosimilars, in the event of a national emergency or cases of extreme urgency.
And the power of determining what comprises a national emergency or extreme urgency lies with the government involved. This would also encompass public health crises like tuberculosis, HIV/AIDS and dengue, among others.
Source: http://www.star2.com/
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