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After the Paxlovid medical insurance negotiations were out, the long-dormant "patent compulsory license" once again became a hot spot in the society, and some medical and legal professionals called for China to implement "patent compulsory licensing" for the first time to meet China's urgent demand
for special patented drugs when a major public health crisis occurred.
for special patented drugs when a major public health crisis occurred.
On January 8, the negotiation of the 2022 national medical insurance drug list officially ended, and the much-watched Pfizer new crown oral drug Paxlovid was finally not selected
due to high quotations.
This means that after the expiration of the temporary medical insurance reimbursement policy, that is, after March 31 this year, patients need to purchase the drug
at their own expense.
As a drug for the treatment of new crown, Paxlovid was approved for marketing in China in February 2022 and has been successively included in the ninth and tenth editions of China's new crown diagnosis and treatment plan, for the treatment of mild and medium-sized adult patients
with high-risk factors for progression within 5 days of onset.
In the new crown diagnosis and treatment plans or recommendations issued by Peking Union Medical College Hospital, Sichuan West China Hospital and other institutions, Paxlovid has been listed as a recommended drug
for antiviral treatment.
In the context of many places entering the peak of severe new crown disease, Paxlovid is sought after by the market and "one drug is difficult to find"
.
At present, Paxlovid has been issued in community health centers in many places, and during the implementation of the temporary medical insurance reimbursement policy, the medical insurance payment price is 1890 yuan / box, calculated according to the reimbursement ratio of 90%, and the patient only needs to pay 189 yuan
out of pocket.
But in some informal channels, each box has even been speculated to tens of thousands of yuan
.
After the medical insurance negotiation is out, for most people, the price of about 2,000 yuan per course of treatment is not cheap
.
In this regard, the well-known Weibo big v "Chengdu Sewer" publicly called for the exercise of the right of "compulsory license for pharmaceutical patents" to produce a Chinese version of Paxlovid generic drugs
.
This proposal has recently aroused extensive discussion
in the medical and legal circles.
Earlier, Liu Shuqing and four other lawyers publicly requested the National Health Commission to expand imports of Paxlovid and asked Pfizer to agree to sell generic drugs in China, otherwise "compulsory licensing of patents should be implemented"
.
"Patent compulsory license" refers to the government's compulsory granting of the right to exploit a patent by a third party other than the patentee, and Paxlovid's compulsory license has precedents internationally, such as the Indian government's approval last year for Indian companies to forcibly generic the drug and use it urgently in India to fight the COVID-19 epidemic
.
Article 54 of the Patent Law of the People's Republic of China stipulates that in the event of a state of national emergency or extraordinary circumstances, or for the purpose of public interest, the patent administration department under the State Council may grant a compulsory license
to exploit an invention patent or utility model patent.
However, China's "compulsory patent license" is still in "zero practice"
.
In this context, what do you think of the call by some clinicians and industry experts for Paxlovid to implement a "patent compulsory license"? Have the timing and conditions for launch been met today? The "medical community" consulted Shao Rong, executive dean of the Institute of Drug Regulatory Sciences of China Pharmaceutical University and executive deputy director of the National Drug Policy and Pharmaceutical Industry Economy Research Center, Hu Shanlian, professor of the School of Public Health of Fudan University, and Yuan Yang
, a partner and patent lawyer at Shanghai Dabang Law Firm.
Here are the experts' answers to the relevant questions:
Medical Profession :
Paxlovid failed to enter medical insurance due to high quotations, in this regard, some clinicians and industry experts said that India can use the rights granted by the WTO in a reasonable and compliant manner to produce the Chinese version of P drugs.
Shao Rong: Initiating compulsory patent licenses requires special caution
.
Up to now, it has been a month since China liberalized epidemic control measures, and it should assess whether there is a state of urgency in the national interest and public interest, the clinical value of P drugs, whether there are similar therapeutic drugs substituted in the market, whether there are similar drugs under clinical research and approval to accelerate the market, etc.
, and comprehensively assess the current situation of the national conditions before deciding whether to initiate compulsory licensing
.
Because compulsory patent licensing is, to a certain extent, a variation of legal principles, a country arbitrarily/easily/often initiates compulsory patent licensing, constantly challenging and undermining the dignity of the rule of law, which will inevitably lead to a crisis
of trust among innovators.
Imagine, if innovators do not trust us, will it affect the future of innovative products and innovative technologies to enter our country? If so, the impact is immeasurable
.
In fact, the negotiation of P drug medical insurance was unsuccessful, involving the question of who pays and how much, which is indeed partly because this burden problem affects the accessibility of some patients to the drug, but it is not enough to become an inevitable reason
to file a patent compulsory license.
Therefore, after a comprehensive assessment, it is prudent to decide whether to make a compulsory license for a patent
.
Hu Shanlian: The research and development of new drugs is arduous and long, and there will be a patent term after it is approved for marketing, which may be 8-10 years
.
During this period, the new drug is expensive and cannot be imitated
.
So, there are two international approaches
to ensuring that developing countries have access to new drugs during major public health events.
The first practice, called "parallel importation", refers to the act
of a third party importing a patented drug sold in the market of one country with the holder's permission or consent to another country for sale without the permission of the patent holder.
The second is to apply for a "compulsory patent license"
.
That is, I do not comply with your patent requirements and force the imitation of the relevant drugs, referred to as "strong imitation"
.
In November 2021, the Medicines Patent Pool (
MPP) announced an agreement
with Pfizer, a Paxlovid innovator.
Pfizer agreed to put the drug's patent in a patent pool, allowing generic drug manufacturers in other countries and regions to produce it, without collecting royalties
for the sale of the drug in low-income countries.
This means that since then, Paxlovid has no public patents
.
On March 17, 2022, MPP announced that it has signed licensing agreements with 35 companies around the world to commission the production of Paxlovid generics
.
Among them, there are 5 Chinese enterprises, some of which are only authorized to produce APIs, and some can produce both APIs and generic drugs
.
These drugs will be supplied to 95 low- and middle-income countries and regions around the world, covering about 53% of the world's population
.
China is not on
this supply list.
If China now imitates Paxlovid, the benefit is that in the event of public health events, we can improve national health and increase access to
medicines.
Conversely, this will have a greater impact on the trade of the entire world and damage China's image
as a great power.
At present, we are committed to improving China's business environment, and the loss of the world market for a medicine is not worth the loss
.
Medical community: Up to now, the compulsory license of pharmaceutical patents is still in the state of zero implementation in China, what do you think are the possible reasons behind it? How do I evaluate the timing and conditions of activation?
Medical community: Up to now, the compulsory license of pharmaceutical patents is still in the state of zero implementation in China, what do you think are the possible reasons behind it? How do I evaluate the timing and conditions of activation?Shao Rong: China's compulsory licensing system for pharmaceutical patents is stipulated by the Patent Law, but in practice it is still in a "vacuum", and on the whole it is still very cautious, requiring a scientific and rational attitude
.
In addition to challenging the dignity of the rule of law and damaging the reputation of the rule of law just mentioned, we must also consider our own development, and easily/arbitrarily/often initiate patent compulsory licensing, which will seriously affect the enthusiasm of innovators to innovate and have a negative impact
on the improvement of the R&D and innovation capabilities of China's pharmaceutical enterprises.
If you want to start a compulsory patent license, you must first conduct a comprehensive assessment and certification of the urgency of the national interest and the public interest, and this process must be very meticulous, that is, if this measure is not taken, will the national interest and the public face greater damage?
Secondly, it is also necessary to consider whether China already has similar drugs, including drugs in the clinical research pipeline, use clinical data to speak, and promote drugs in clinical research and market-registered drugs with priority review and conditional approval to the market to meet the needs of multiple parties and solve the problem of
insufficient supply.
Especially for drugs with the same mechanism of action of Paxlovid, if there is a certain clinical data to support it, the drug regulatory department can conditionally approve it to promote early marketing and benefit more patients
.
Hu Shanlian: More than 10 years ago, a representative of the World Health Organization visited China and came to us to ask for my opinion
on "strong imitation".
At that time, China formed a legal basis for patent protection, but so far there has been no "strong imitation"
.
During the same period, India has made "strong imitations"
of many high-priced imported drugs.
As a result, many countries have strict requirements for the import and export of drugs in India, believing that their markets are not regulated enough and do not comply with patent laws
.
Returning to Paxlovid, Paxlovid has some therapeutic effects for outpatients with mild and moderate COVID infection, including reduced deaths and hospitalizations, but not a miracle drug
.
As far as the tenth edition of China's latest version of the diagnosis and treatment plan, Paxlovid is one of the drugs, but it is not the only therapeutic drug
.
More importantly, China is committed to the research and development of new crown treatment drugs, such as VV116, SIM0417 and other domestic drugs may be approved and marketed
in a few months.
In this case, the "strong imitation" Paxlovid will still take several months, and bioequivalence tests will need to be carried out to prove the efficacy before it can be marketed
.
If our generic drugs do not work well, there is no need
for strong imitation.
Yuan Yang: Paxlovid is a new drug and will be patented
in 2021.
Under the extraordinary circumstances of the new crown epidemic, if a "compulsory license" is implemented for the purpose of public interest, the provisions of Article 54 of the Patent Law of the People's Republic of China (2020 Revision) shall apply, that is, "in the event of a national emergency or extraordinary circumstances, or for the purpose of public interest, the patent administration department under the State Council may grant a compulsory license
to exploit an invention patent or utility model patent.
" ”
"Compulsory patent licensing" is a last resort
that cannot be negotiated.
At present, negotiations on Paxlovid are stuck in price, not concession, and there is still room
for negotiation.
It should be noted that the "compulsory patent license" is mainly to meet the domestic market, and related drugs can be sold
in China.
In case of export, patents are subject to local laws
.
Medical community: After Paxlovid was not insured, some experts suggested that the FDA negotiate with Pfizer on the authorization of generic drugs, what do you think of this suggestion?
Medical community: After Paxlovid was not insured, some experts suggested that the FDA negotiate with Pfizer on the authorization of generic drugs, what do you think of this suggestion?Shao Rong: The authorization of generic drugs should be more of a market behavior of market entities, that is, an agreement between Pfizer and the imitator, and the Food and Drug Administration is responsible for approval
.
Generally speaking, the administrative department will not take the initiative to negotiate market rights and interests with Pfizer, if so, it means that it is a state of emergency, and the possibility of initiating compulsory licenses is greater
.
So I don't think it's the FDA's job
to bring up generic drug authorization.
Hu Shanlian: The next step is to go your own way
.
On the one hand, continue to promote Paxlovid to achieve price
reductions through price negotiations.
This time it did not enter Medicare, mainly because the price was higher
.
After renegotiation, it is difficult
to reduce the price to and whether it can be reduced to less than 1,000 yuan.
Second, drug pricing needs to consider and balance international prices
.
It is important that when domestic new crown drugs are launched, if the clinical effect of the head-to-head non-inferior test is similar to Paxlovid, it is conducive to promoting Paxlovid to reduce prices
.
We don't even need to introduce the drug
.
On the other hand, we can move drug negotiations
forward.
Since there are already 5 pharmaceutical companies in China, can we negotiate to cancel the patent fee for generic products in China, or allow generic drugs produced under the MPP agreement to be sold
in China.
This negotiation involves not only medical insurance, but also the participation
of the Ministry of Industry and Information Technology and the entire pharmaceutical industry system.
Finally, even if they do not enter medical insurance, people can still buy and use this drug
through the market at their own expense.
