The survival challenge of new drugs is constant, who will be the lucky future?
In the examination and approval process, the state's macro-management functions for orderly planning, dynamic guidance and early warning of industry and enterprise projects need to be strengthened. Enterprise projects are blindly piled up, and a new product has not yet been approved. Hundreds of enterprises have been homogenized and declared to be destined for future products. The road is not smooth.
New drugs are not only innovative drugs, but products that have improved in terms of efficacy, safety and cost of treatment compared to existing products for clinical applications.
New drug survival challenges
The new product approval cycle is long, the market transformation is slow and difficult, the cost investment is large, the previous operation is unable to make ends meet, the homogenization products are out of order, the market access period is long, the competition is disorderly, and the product life cycle is greatly shortened, which is the new drug development in China. Universal dilemma.
A good product can only be reincarnation after more than a decade of war. The product of the 20-year patent period has been consumed for 12 years. It will take 5 years to enter the market for sales and wait for market access such as medical insurance. During the period of maturity and stability, huge investment and long waiting period have become the winter and winter of new drugs. If you can’t hold it, you can’t stand it and you can’t stand it.
In the examination and approval process, the state's macro-management functions for orderly planning, dynamic guidance and early warning of industry and enterprise projects need to be strengthened. Enterprise projects are blindly piled up, and a new product has not yet been approved. Hundreds of enterprises have been homogenized and declared to be destined for future products. The road is not smooth. Many new products have not yet been born, they have become short-lived products and generic drugs.
In the past two years, due to the delay in medical insurance and network connection, only four or five provinces have opened the bid in one year. The normal hospital registration and procurement (proximity) has been strictly controlled, and new drug marketing is generally in trouble. The state has ensured that the proportion of base medicines and common medicines is large, and the products in the hospital are cleaned in large quantities. The self-funded new products that have not yet begun to apply for medical insurance, even if they are lucky enough to catch up with the tenders, have begun a long wait for hospitalization. What is even more disturbing is that some medical reform pilot areas only recruit medical insurance products, basic medicines and new agricultural cooperative catalogue products. Except for some innovative medicine products, other self-funded products have not entered the direct export catalogue. Document No. 70 requires all localities to prepare bidding catalogues based on 80% of the products used in the previous year. Other products are directly classified into different categories according to different catalogues. In some places, the self-funded medicines are often missed, and the sales volume in the hospitals is large and the amount is high. The product has further exacerbated the crisis of new products.
The cost of research and development of a new product in the past ten years is tens of millions. In addition to the GMP transformation, environmental assessment, and market investment, the company has already hanged a few tens of millions of dollars and more than 100 million yuan of the cost to be distributed. The price of lowering the drug ignores the pricing rules of different life cycles and different stages of the product. The mature products do not fall, the drop is low, the new products are brushed and the waist is paralyzed. The second bargaining is to completely demand the life of the enterprise and the product. More than 80% of domestic R&D investment is concentrated on new drugs. New drugs do not specifically refer to dozens of new products. For those products that have improved on existing products, quality, efficacy, safety, and cost-effectiveness of treatment, they should be supported. Encourage, the level of medication and health of the Chinese people can be guaranteed, and in the future, they will not encounter the shortage of medicines, expensive medicines, and difficult medications.
The environment is getting worse and worse, the disease is getting more and more, and the incidence is getting higher and higher. It is used to help the people get rid of the disease and recover from the doctor's medical skills. It is more necessary to treat the disease and cure the disease. The transformation of medical reform into drug reform will kill the survival and development space of new drugs, causing huge losses for enterprises. The medical burden of the state and the people is becoming heavier, the marketing of new drugs is facing a lockout, the development of new drugs is facing a break, and the development of the pharmaceutical industry is facing difficulties.
Who will be lucky in the future?
The cost and threshold of new drug research and development are constantly improving, and the future is bound to be higher and higher. Clinical trial data verification, consistency evaluation, and flight inspections all force companies to continuously improve the true level of research and development and product quality. The more standardized enterprises benefit from it. However, it is not enough to raise the threshold for funds and technology. It is necessary to increase guidance and support for the efforts of enterprises to help enterprises improve the standardization and success rate of new product development declarations, so that more medicines have the opportunity to help patients improve their health. . It is often ten or twenty years to grind a great product. Under the premise of ensuring safety, the products with valuable potential should be given opportunities for encouragement, guidance and correction in various explorations, and there are mechanisms for innovation and support. It is more conducive to product innovation.
Children's medicines have already tasted the great benefits brought by the policy, and can be shunned by a separate procurement catalogue. Need to pay attention to is that many products do not have a separate child dose package, only need to halve the adult dose, the same quality and cheap, widely praised by the clinic, should give such products the same living space, avoid policy accidental injury Out of the hospital, replaced by a higher-priced child-specific packaging. Another problem is the pricing of the product. If there is no difference between the adult and the same process, the dosage is halved. It is easy to become the next high price range. Child drug abuse also needs to be highly valued. The same is true for gynecological medication.
New policies such as the declaration of green channels and the implementation of national major illness medical insurance have brought about a spring breeze for the development or imitation of some major diseases such as oncology drugs. The effective control of toxic side effects and treatment costs of cancer products has become the focus of attention, avoiding policy implementation and departure. Partial. First-aid medicines and therapeutic drugs have also become popular targets in the market and research and development.
The chronic disease medication is also a big cake. It is worth noting that the current medical reform system is not conducive to the most convenient use of drugs for patients. The old disease number that has been used for a long time in decades has to go to the pharmacy to have a prescription, go to the community hospital without medicine, and finally open the patient. The drug is forced back to the big hospital to queue up, increasing the burden on patients and the burden on the hospital. Promote barrier-free retail conversion of commonly used prescription drugs, and play the normal role of pharmacies to avoid complicated things. With the merging of dosage forms and similar drugs, the strict control of the number of hanging net products, and the homogenization of products will be largely eliminated, the multi-channel sales of related enterprises need to be laid out in advance, and the previous clinical sales will be transformed into retail seamlessly.
Regarding adjuvant medications, it is necessary to avoid the abuse of wildness in the past, and to avoid taking such medications to the end, from one extreme to the other. Vitamins, myocardial nutrition, tumor radiotherapy and other auxiliary drugs still have a certain auxiliary therapeutic effect, protect the body and speed up the cure. It is up to the patient to decide whether to use it more scientifically depending on the condition and the patient's condition. Limitation of resistance to the highly concentrated use of catalogue products is also very easy to increase the risk of resistance, and it needs to be more scientific and rational distribution.
How does the policy benefit?
Another impact and confusion of the medical reform on new drugs is the integration of urban and rural areas, completely breaking the law of gradual and progressive use of drugs, resulting in no good medicinal use by urban residents. There are many complaints, and rural residents are using waste drugs and new drugs ahead of time. How to more reasonably determine the network cycle, avoiding the years before, and not expecting to wear Qiu Shui and now the annual recruits, the annual sports and the people, and effectively open the hospital's independent record procurement, the original operation of the medical institutions will be returned to the latter, respect the market rules, improve the profession Standardization and strengthening supervision are more conducive to market prosperity and stability.
Policy orientation determines how the medical development in the next decade will be laid out. How to create more market transformation conditions for new drug innovation, effectively reduce the burden and cost of enterprises, help enterprises accelerate the realization of sales transformation, and achieve large-scale operation, in order to more effectively reduce drug prices, to achieve the state, the public, medical institutions and pharmaceutical companies Multi-win.
If the new drug loses its living space due to policy restrictions, the pharmaceutical industry and the health of the people will be in danger. The medical industry is shut down, and medical institutions cannot support it alone. Please also respect the efforts of medical people for the health of the national health and leave room for development for the national pharmaceutical industry. Without good medicine, Hua Tuo is also alive. In the face of complicated disease spectrum, our good medicine is not too much, but too little.
(Jilin Qijian Biotechnology Co., Ltd. www.qjbio.com.cn)