Social Pharmacy and Pharmacoeconomics. Drug Regulation and General Principles of Drug Politics. JAMASOFT2017

Drugs as an instrument of public health. National drug expenditure as a proportion of total health expenditure currently ranges from 7% to 66% worldwide. The proportion is higher in developing countries (24%-66%) than in developed countries (7%-30%). In the former, at the individual and household level, drugs represent a major out-of-pocket health care cost. JAMASOFT2017

Public health and safety concerns have obliged governments to intervene in the activities of the pharmaceutical sector. Guaranteeing the safety, efficacy and quality of drugs available to the public is the main goal of drug regulation. JAMASOFT2017

form the foundation of drug regulation. Legal structures form the foundation of drug regulation. JAMASOFT2017

The structures of drug regulation that exist today ⎯ drug laws, drug regulatory agencies, drug evaluation boards, quality control (QC) laboratories, drug information centres, etc. ⎯ have evolved over time. JAMASOFT2017

Drug regulation is therefore a public policy response to the perceived problems or perceived needs of society. Consequently, drug laws need to be updated to keep pace with changes and new challenges in their environment. JAMASOFT2017

Drug Regulation Authorities (DRA) We have to speak about Drug Regulation Authorities (DRA) JAMASOFT2017

Drug regulatory authorities in most countries expend far more time and effort on pre-marketing than on post-marketing activities. JAMASOFT2017

Several areas in drug regulation receive relatively little attention in the implementation process. The informal sector, post-marketing surveillance and control of drug information were the most important of these. JAMASOFT2017

Which are the general tools of drug politics? Drug registration (authorization). Drug categorisation for reimbursement. Drug reference pricing. Prescribing restrictions, indication restrictions. Uniform Therapy Guidelines. Other general Legislation (Such as Pharmacopoeia, Narcotic drugs and Psychotropic substances.) Drug price regulation. JAMASOFT2017

Ad 1. Drug registration (authorization). Product assessment and registration (also known as marketing authorization and product licensing) are carried out by drug regulatory authorities to ensure that a pharmaceutical product has been adequately tested and evaluated for safety, efficacy and quality and that the product information provided by the manufacturer is accurate (SPC,PIL). JAMASOFT2017

Ad 2. Drug categorisation for reimbursement. This is a specialized field of health economics that looks at the cost/benefit of a product in terms of quality of life, alternative treatments (drug and non-drug) and cost reduction or avoidance in other parts of the health care system (for example, a drug may reduce the need for a surgical intervention, thereby saving money). JAMASOFT2017

Ad 3. Drug reference pricing. The reference pricing, or international price comparison, is a commonly employed instrument to control prices of pharmaceuticals that are protected by intellectual property rights and benefit from a legal monopoly (in-patent drugs). JAMASOFT2017

Ad 4. Prescribing restrictions, indication restrictions. The development of prescriptions restriction is one policy tool becoming popular in controlling pharmaceutical spending. While traditionally reimbursement decisions applied to the officially registered indication, authorities have recently been imposing restrictions on the claim made for the drug. These restrictions usually relate to follow a treatment protocol, to limit the prescribers or to limit the range of indications. Through the creation of prescription guidelines for certain conditions, the health care authorities can exercise control over physicians’ prescribing. JAMASOFT2017

Ad 5. Uniform Therapy Guidelines. The Medical Treatment Guidelines (also called Medical Practice Guidelines) are evidence based and were developed by in collaboration with practicing physicians and advisors. Some guidelines are intended to be educational tools for medical providers. Some guidelines and the review criteria are used by health care politics and claim management process to promote best practices and improve the health of injured workers. They are published by the health authority which is solely responsible for coverage decisions that may result from their use. Health care providers are expected to be familiar with the guidelines and follow the recommendations. Good medical judgment is important in deciding how to use and interpret this information. JAMASOFT2017

Ad 6. Other general Legislation - Such as Pharmacopoeia, - Narcotic drugs and Psychotropic substances Low JAMASOFT2017

Ad 7. Drug price regulation. Government-regulated prices could greatly impair the ability of managed care organizations to design a competitive benefit offering that integrates clinically sound, evidence-based medication choices with delivery systems and co-payment alternatives that provide beneficiaries with substantive choice. Managed care organizations have developed formulary systems alongside prudent purchasing practices to encourage appropriate drug prescribing, dispensing and utilization. JAMASOFT2017

Ad 7. Drug price regulation. Government regulation of prescription drug prices may also jeopardize the research and development of new pharmaceutical products. Government-regulated prices could dampen innovation due to costly research and development. JAMASOFT2017

The financial sustainability of the drug regulatory authority (DRA) is a critical factor in the continued implementation of the various drug regulatory functions. JAMASOFT2017

The Phenomenon of the Parallel Imports of Proprietary Medicines. JAMASOFT2017

Parallel imports are imports of a patented or trademarked product from a country where it is already marketed. JAMASOFT2017

According to the theory of exhaustion of intellectual property rights, the exclusive right of the patent holder to import the protected product is exhausted, and thus ends, when the product is first launched on the market. When a state or group of states applies this principle of exhaustion of intellectual property rights in a given territory, parallel importation is authorized to all residents in the state in question. In a state that does not recognize this principle, however, only the patent holder who has been registered has the right to import the protected product. JAMASOFT2017

Sometimes referred to as “grey market” imports, parallel imports often takes place when there is differential pricing of the same product - either brand-name or generic drugs - in different markets (usually owing to local manufacturing costs or market conditions). JAMASOFT2017

Parallel imports can reduce the price of health products and pharmaceuticals by introducing competition. However, they can also affect the negotiation of tiered pricing regimes with pharmaceutical companies. If a private pharmaceutical company agrees to sell a product at a lower price in poor countries, it will need some assurance that the cheaper product will not be imported back into its rich country markets, undercutting its profits (product diversion). JAMASOFT2017

The European Commission has published a Communication clarifying how the principle of free movement of goods within the EU applies in practice to parallel imports of medicinal products. JAMASOFT2017

Parallel imports are products imported into one Member State from another and placed on the market in the destination Member State, outside the manufacturer's or its licensed distributor's formal channels. JAMASOFT2017

In the case of medicines, such imports are allowed if the product imported is identical or sufficiently similar to one already authorized for sale in the Member State of destination. Aiming to help businesses and national administrations take full advantage of the internal market in medicinal products, the Communication covers the rights and obligations of the parties concerned and the guarantees to which they are entitled according to EU law. JAMASOFT2017

The prices of medicines differ among the EU member states, and this fact - combined with the basic principles of the free movement of goods – makes parallel import of medicines interesting, even though this trade is subject to many restrictions. All distributed pharmaceuticals must for example be approved by the national medicine regulatory authorities or by the European Medicines Agency (EMA). Parallel importation is the cross-border importation of the cheapest-priced drug from another country. JAMASOFT2017

Thanks for your time and willingness. JAMASOFT2017