The Life Sciences Law Review: Mexico
The Mexican Federal Constitution establishes health as a fundamental human right and provides the basis for the government to enact provisions related thereto. Article 73 of the Constitution grants the Mexican Congress authority to issue laws regarding health matters. Under this provision, the government has enacted diverse laws and regulations concerning medicines, pharmaceuticals, devices, food and beverages, dietary supplements, tobacco, vaping, cannabis and other goods and activities deemed to have an impact on human health.
The main law in this area is the Mexican General Health Law (the Health Law), which provides that certain products, including, inter alia, pharmaceuticals, narcotics, devices, food and beverages, dietary supplements, etc., and diverse processes related to these, are subject to sanitary control, this latter being comprehensive of manufacturing, packaging, handling, transportation, distribution, warehousing, etc.
The Health Law specifies that the authorities in charge of medicines, devices and most other regulated products are: the President of Mexico, the General Health Board, the Ministry of Health2 and state governments (on state jurisdictional matters).
The Ministry of Health has the broadest jurisdiction regarding these goods and activities. Moreover, the Health Law details the specific areas of competence for the diverse authorities in health matters, including the particular roles of the executive branch, the Health Board the state governments, etc.; other laws also establish particular competence for these authorities such as the Tobacco Law or the Federal Law on Metrology and Normalization.
In addition to Congress' authority to enact laws, the executive branch has the authority to issue regulations that clarify or specify the content of existing laws, without extending beyond or contravening the law being interpreted.
Among the most relevant regulations are the Health Law Regulations for Health-Related Goods (the Goods Regulations), the Health Law Regulations for Health Research (the Research Regulations) and the Regulations of the Health Law in Publicity Matters (the Publicity Regulations), etc.
Products and services imported, marketed or rendered in Mexico are also subject to Mexican official standards (NOMs). These are administrative guidelines that establish technical specifications, characteristics, processes, operation requirements, etc. in Mexican territory. Before these are issued, the corresponding governmental entity, (e.g., COFEPRIS), prepares and issues draft guidelines that permit interested parties to participate in their creation or amendment.
Other provisions can be issued by the authorities as internal guidelines, decrees or accords, which may or may not be published in the Federal Official Gazette. Finally, although the Mexican legal system is not common law based, precedents regarding the nature of health provisions have been decided by the Mexican courts. Many of which focus on the interpretation of health as a constitutional and human right and its prevalence upon other such rights and vice versa.
The regulatory regime
In all cases, pharmaceuticals, devices and other products and services that have effects on human health are regulated at the federal level. These include, among others, research; food and beverages; human tissue and DNA; psychotropic and narcotics; toiletries and cosmetics; toxic substances; publicity; tobacco and alcoholic beverages; medical software and telemedicine; etc.
The Health Law and other provisions establish general licence, procedure and penalty requirements applicable to these goods and activities. Regulations, NOMs and guidelines establish additional or more specific requirements to each type of product and service.
The Health Law, its regulations and other provisions provide specific definitions of medicines, medical devices and other products and services subject to sanitary control. In some cases, where specific legal provisions have not been enacted, it is quite common to have the competent authorities resort to provisions based on 'similarities' or broad general concepts within other provisions.
The Health Law defines medicines as substances having therapeutic, preventive or rehabilitative effects identifiable on pharmacological, physical, chemical and biologic characteristics and classified based on diverse criteria as: allopathic; homeopathic; herbal remedies; prescription; controlled prescription; over the counter; vitamins; biotechnological; orphan drugs; traditional or indigenous medicines; etc.
In addition to the above, other regulated products include toxins, anti-toxins, vaccines, serums, parenteral preparations, blood products, microbial and fungal preparations, hormones, enzymes, etc.
The Health Law identifies six main types of medical devices (medical equipment; prostheses and functional aids; diagnostic agents; dental products; surgical material; and hygienic products), which are classified based on their risks, safety and efficiency into three classes: Class I: well-known in medical practice and not body-invasive; Class II: known in medical practice or body-invasive for periods shorter than 30 days; and Class III: new or recently accepted in medical practice or remaining in the body for periods greater than 30 days.
Certain NOMs and internal criteria include additional requirements for products that, although not formally medical devices under the Health Law or its Regulations, have been included under its scope by the authorities, as possible new technologies (APPS and software), electric and electronic products used in 'wellness', holistic therapies and similar procedures, telemedicine services, etc.
ii Non-clinical studies
There is no specific restriction regarding the use of non-clinical studies. The party performing the non-clinical study is solely responsible for assuring good laboratory practices and that these studies do not represent a risk to human health. Under certain state legal provisions, including those regarding animal welfare, certain risks exist of interpretations that may lead to restrictions for these activities.
iii Clinical trials
In contrast with non-clinical trials, clinical trials are subject to extensive regulation. The Health Law, the Research Regulations and specific NOMs regulate clinical trials. These may involve research on prophylactic, diagnostic, therapeutic and rehabilitative resources; bio safety risks; DNA and biotechnology; and radiation.
Clinical trials are classified based on the risk they may pose to the test subjects and are divided into non-risk research; minimum-risk research; and greater-than-minimum-risk research.
Research involving human beings requires authorisation prior to its commencement. The performing parties must provide the authorities with information regarding the scope and purpose of the research, the main investigator, approval of the institution's committees and informed consent of the subjects.
In principle, clinical research should only be carried out at health institutions under the direction of a principal investigator who is a health professional, member of such institution and the latter guarantees possible damages arising therefrom, medical treatment required and potential indemnification to subjects.
In the case of sponsorship or other forms of remuneration, measures to prevent conflicts of interest for protecting test subjects, preservation of results and assignment of resources should be implemented.
Certain legal concepts associated with clinical trials, such as CRT agreements and sponsorship and activities, are not regulated by Mexican law; however, in practice the authorities have issued internal criteria, compliance with which is required to obtain the authorisations, and included some references in NOMs or other administrative criteria.
Currently, it has become a fairly common activity for legal entities or individuals to carry out data and information collection of a medical or investigative nature thorough new technologies (apps, software and similar means) that are not specifically regulated as information considered as a clinical trial subject to permits and authorisations.
iv Named-patient and compassionate use procedures
Only one exception exits for using a product before it has received marketing authorisation (MA). This is in the case of clinical trials that may save a patient's life or health, or eliminate pain, provided the patient has supplied written consent.
Notwithstanding, the Mexican courts have issued recent criteria establishing that irrespective of the restriction to import and use regulated products subject to MA, the health authorities must permit their use considering the greater relevance of the human right for life in relation to the general health protection and exclusivity of cleared products.
One these is the 'Grace case', which resulted in specific amendments to the provisions included in the Health Law regarding psychotropic substances derived from cannabis and their use in pharmaceuticals.
v Pre-market clearance
Currently only medicines and medical devices require registration with COFEPRIS, the same that is granted based on available information regarding their safety among which is: technical and scientific data; therapeutic efficacy and safety; use and prescription; labelling; certificates from country of manufacturing; etc.
If the product is considered safe, the registration is issued and the products can be manufactured, imported and marketed in Mexico. As an alternative to the general registration process, this information can be pre-reviewed by a private authorised entity, and a fast-track registration may be granted. This kind of registration is also available for products holding MA in jurisdictions with which mutual recognition agreements have been executed.
Both Mexican and foreign laboratories that manufacture pharmaceutical products may obtain MA. For medical devices, it is not necessary to have manufacturing premises in Mexico or abroad to obtain MA, however the requesting party must be registered with COFEPRIS and provide the required documents.
vi Regulatory incentives
Patent term extensions
Mexico does not provide patent term extensions or grant delays. However, as a signatory of the Unites States–Mexico–Canada Agreement (USMCA), expected to be ratified and become mandatory at some point in 2020, it shall enhance intellectual property protection for pharmaceutical products, since under such agreement, the member parties must 'make available an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process'.
Link between regulatory approval processes and patent expiry
The Regulations for the Industrial Property Law and the Goods Regulations establish a linkage mechanism to observe patent rights. This has been subject to a considerable number of litigation actions since its enactment.
The Mexican Patent Office (IMPI) issues a Gazette containing patents in force covering:
- active ingredients (including polymorphs);
- biologics; and
- some use patents.
Published patents do not have a correlation with approved products (patents can be published even if the corresponding product is still at a clinical trial stage, or the approval has been refused.
Upon receiving an MA application for a generic drug or biosomilar, COFEPRIS will formally request from the IMPI an opinion regarding whether the requested MA infringes patent rights. The applicant is informed of the IMPI's opinion, without the involvement of the patent holder.
The Goods Regulations also establish a Bolar-type three-year exemption to apply for MAs associated to patents close to expiry.
Data and marketing exclusivity
Data and marketing exclusivity for pharmaceutical products is an obligation under NAFTA, which has only been regulated through an internal guideline from COFEPRIS, that includes a five-year period of data exclusivity.
vii Post-approval controls
Holders of MAs must maintain the conditions upon which such were granted while these are in force. Changes thereto may result in cancellation. Changes to the background upon which an MA was issued must be filed for approval. The health authorities may verify that premises where processes are carried out meet the necessary GMPs or sanitary conditions.
In the specific case of pharmaceutical vigilance, in addition to the general procedures set out by the Health Law, those of the applicable NOM must also be satisfied.
viii Manufacturing controls
Medicines, devices, food and beverages, tobacco and other regulated product's manufacturing is subject to sanitary control and includes requirements regarding premises where related 'processes' are carried out. In some cases, laboratories or other kinds of premises may be authorised to process products subject to this requirement through the issuance of a sanitary licence. The Health Law establishes different types of premises that may be authorised to operate in Mexico, including factories or laboratories of medicines, homeopathic or herbal remedies or biological products for human use, etc.
Premises where pharmaceutical products are manufactured must as a general rule evidence 'good sanitary practices'; have quality control laboratories; appoint specific individuals with the health authorities as representatives of the entity; provide, as required, information regarding products, services, processes and, as the case may be, specific administrative controls (e.g., narcotics and psychotropic).
Compliance with these requirements can be verified through inspections following the filing of an application or through an alternative verification process called an operation requirements compliance certification. Once approved, the Health Authority will issue the corresponding licence.
Additionally, these premises must meet specific operational and manufacturing requirements set out in certain NOMs depending on the kind of products to be manufactured, including, inter alia, materials handling procedures; lot controls and production; testing; raw materials and finished-product inventory control systems; SOPs for production controls; manufacturing processes' validation; compliance with NOMs certifications; samples and documents preservation; labelling compliance; etc.
ix Advertising and promotion
The Publicity Regulations define the term 'publicity' as any activity that includes all creation, planning, playing and broadcasting processes of advertisements in communication media with the purpose of promoting the sale or consumption of products or services.
The Health Law differentiates between publicity intended for health professionals and for the public, the former being that regarding the characteristics and use of medicines, medical devices and medical or scientific information used for publicity or promotional purposes restricted to specialised media and based on the content of the products' MA and the latter intended for the public at large, which requires specific permits and is only applicable to OTC medicines and herbal remedies.
Promotional materials regarding pharmaceutical products and medical devices in Mexico are not subject to authorisation, provided these do not include information other than the names of the products and the entity manufacturing or distributing them or both. Likewise, activities carried out involving health professionals are generally not subject to restriction, because it is possible to organise or sponsor congresses, sessions, courses, etc. regarding products, and to provide sample products, gifts, hospitality and entertainment.
x Distributors and wholesalers
Distribution and wholesale of pharmaceutical products and devices are 'processes' subject to sanitary control by the Mexican health authorities and subject to restrictions and conditions depending on the specific type of sanitary licence.
The Health Law and applicable regulations establish different premises subject to sanitary control and specific requirements for each. Generally, premises for the wholesale and distribution of pharmaceutical products and medical devices is subject to compliance with specific requirements for warehousing, transportation and control.
xi Classification of products
The Health Law and corresponding regulations set the rules and conditions for classifying pharmaceutical products, medical devices and other regulated products and services. This classification determines the conditions for marketing goods and specific permits and authorisations for related processes. The specific criterion for products classification may be determined by the health authorities.
xii Imports and exports
The Health Law identifies importation and exportation of goods as a 'process' subject to sanitary control and general requirements. Specific requirements apply based on the product and its tariff classification.
For products imported into Mexico, the general requirements include registration of the importer of record with the General Importer's Registry, the appointment of a customs broker or in-house broker, and registration with the Specific Sectors Importer's Registry for clearance through specific customs houses.
Goods importation triggers general import duties at the rate for tariff classification number and value of goods. Most products exportation is exempt from export duties. Likewise, importation of goods triggers value added tax. For finished pharmaceutical products this is zero per cent or exempted. Medical devices are subject to the 16 per cent general rate under the Value Added Tax Law.
Non-tariff requirements are also applicable. For medicines and pharmaceuticals, these are generally subject to the issuance of an import or export permit by COFEPRIS. Medical devices are generally only subject to presentation to the customs authorities of the corresponding MA.
Other products subject to controls may include those bound for wellness purposes, certain kinds of food and beverage and other apparently unrelated items which may represent a health risk.
xiii Controlled substances
Controlled substances include all psychotropic and narcotic substances. The list of such goods is included in specific chapters of the Health Law, which establishes the general requirements applicable to these goods and their classification based on their use and effects.
Under the Health Law, psychotropic substances are divided into those:
- with minimum therapeutic value by virtue of their possible unlawful use and that constitute a particularly serious public health problem;
- with therapeutic value but that constitute a serious public health problem;
- with therapeutic value but that constitute a public health problem;
- with considerable therapeutic value that constitute a minor public health problem; and
- with no therapeutic value and that are generally used for industrial purposes.
Processes involving these substances and those considered as raw materials for manufacturing illegal drugs are subject to specific controls, set forth in the Federal Law for the Control of Chemical Raw Materials, Essential Chemical Products and Machinery for Tablet and Pill Manufacturing and its regulations. This also provides specific regulations regarding production, sale, acquisition, importation, exportation, transportation, warehousing and distribution of certain chemical products, and apparatus for the manufacture of tablets and pills, specific permits and control and reporting requirements.
In 2017, diverse amendments to the Health Law were published, including amendments establishing the possibility to obtain MA for pharmaceutical products deriving from cannabis. These amendments derive from the mentioned 'Grace case' and provide the possibility to import and marked in Mexico pharmaceutical products containing derivatives of this plant. Likewise, the amendments established the possibility to manufacture and market other industrial products derived from cannabis with certain maximum permissible amounts of THC.
The Mexican health authorities may verify at any time the due compliance of applicable provisions of process involving these goods and services. COFEPRIS is generally in charge of these verification procedures, which must meet requirements in the Health Law and the Federal Law on Administrative Proceedings. These procedures must always be served in writing and the scope and purpose of the verification must be established clearly. Once such procedure notice is served, the authorities may initiate the review and verification of documents, premises and processes.
The verification procedures in health matters must meet the general guidelines and requirements for these types of matters included in the Constitution, Health Law and Federal Law on Administrative Proceedings.
All reviews and actions carried out by health authorities in these processes must be included in minutes and finalised with a written resolution in which the findings or potential infractions committed are set out. The determination of the commission of an infraction must always set out the factual background and legal basis upon which it is considered as such, and may be challenged through the applicable legal remedies.
Pricing and reimbursement
Pricing and reimbursement can be broadly divided into two sectors: the private sector and the public sector.
i Private sector
In sales to the private sector, there is an agreement between the National Pharmaceutical Chamber and the Ministry of Economy, called the 'PROMIF', which establishes a way to determine maximum sales prices for new drugs, taking into account reference to prices for new drug products in other countries. Reference pricing is not applicable to generic products or biosimilars.
ii Public sector
In Mexico the government is a direct provider of health services, through different institutions, including the Social Security Institute (IMSS); the Institute of Security and Social Services for State Workers (ISSSTE), which provides services for federal government employees; the Ministry of Defence (SEDENA); the National Oil Company (PEMEX); and the state health bodies.
The new administration has incorporated an Institute of Health for Well-Being (INSABI), which replaces the former Popular Insurance System (Seguro Popular), and is intended to provide health coverage for individuals not covered by other public health systems.
Medicines and devices used in these institutions are directly purchased by the Mexican government through a combination of public tenders and direct acquisition proceedings. Acquisition of products is based on the list included in the National Health Products Compendium, and inclusion in this compendium is based on analysis of pharmaco-economic considerations by the health authorities.
The Health Law includes some specific restrictions regarding the maximum prices for medicines offered for sale to the public at large, it being necessary to include these maximum prices in the labelling. As mentioned above, most medicine sales to governmental health providers are subject to specific bidding procedures under the Law on Acquisitions, Leases and Services of the Public Federal Administration; however, some exceptions to this general rule are applicable. Similarly, the Mexican social security system relies on the direct rendering of health-related services by the competent governmental agencies; no reimbursement procedures exist for goods directly acquired by the population covered by the public healthcare system.
Administrative and judicial remedies
Administrative infringements may be determined independently of possible criminal offences arising from acts or omissions set forth by the corresponding legal provisions. The applicable legal remedy depends mainly on the type of fine or penalty applied to a legal entity or individual, as well as the reasons for such determination. In general, the penalties for failure to comply with obligations set out by the corresponding legal provisions can be fines, seizures, foreclosure of premises, destructions of goods, etc.
Various legal remedies exist for challenging decisions or determinations regarding possible infringements of health-related provisions. These are administrative appeal and the administrative litigous procedure.
i Administrative appeal
Under the Health Law, acts by the health authorities may be challenged through an administrative appeal. This should be attached with the power of attorney of the legal representative; challenged resolution; facts, legal arguments and evidence.
The administrative appeal may confirm, cancel, amend the resolution in specific terms, or order issuance of a new resolution. The resolution of the administrative appeal may be further challenged through the administrative litigious procedure before the Federal Administrative Justice Court.
ii Administrative litigious procedure
Alternatively, resolutions may be challenged through an administrative litigious procedure (nullity petition) before the Administrative Justice Court, based on the Federal Law on Litigious Administrative Procedures.
This nullity petition must be filed before the Administrative Justice Court during the 30 business days following the formal serving date.
The nullity petition may confirm the resolution, declare it null and void, declare partial nullity, or declare nullity for a specific purpose.
Unfavourable or partially favourable resolutions to a nullity petition may be challenged through a direct amparo or constitutional remedy before the Federal Court of Appeals. In specific cases, the resolution issued by an administrative authority may also be directly challenged through filing an amparo when the resolution implies the direct violation of constitutional principles.
Financial relationships with prescribers and payers
Mexican law provides no specific rules regarding financial relationships between pharmaceutical and medical device companies with prescribers and payors, except in some very limited cases involving public health service officials. In the case of acquisitions by government agencies, the Federal Law on Public Servants is applicable in connection with the prohibition to provide any kind of gift to an individual who holds public office when the gift is directly related to his or her activities.
Based on the foregoing provision, it is not possible to provide prescribers or payors with any kind of financial benefit, gift or hospitality if they act as public servants. In the case of private practitioners these restrictions are not applicable. This restriction creates a considerable number of practical issues because many health professionals may hold governmental positions and maintain private practice.
Under the new administration, greater controls and provisions regarding corruption and control of benefits and hospitality have been formally and practically enacted. This has resulted in a more complex regulatory environment when dealing with the supply and sale of pharmaceutical, devices and other goods to the federal and local governments.
In addition, the National Pharmaceutical Chamber (CANIFARMA) and the Mexican Association of Innovative industries of Medical Devices (AMID) are both part of the National Council for Ethics and Transparency for the Pharmaceutical Industry (CETIFARMA). CETIFARMA has issued codes of ethics that follow international guidelines for interactions with prescribers and physicians.
In addition to the above, a considerable number of new provisions and guidelines regarding administrative controls in this connection have been enacted by the new administration. Likewise, new provisions interacting with the existing ones have been enacted and several regulations and interpretations are still awaiting enactment.
Special liability and compensation issues
Special liability or compensation systems
Under Mexican law, there is no specific procedure or system for the compensation of possible injuries or damages arising from use of medicines or medical devices. Individuals who are affected or damaged by a medicine or medical device may file a lawsuit (ordinary civil procedure) to request the compensation of damages. Under Mexican law, only direct damages may be requested, if a direct relationship between the product and the damage can be duly evidenced.
Transactional and competition issues
i Competition law
The Law of Economic Competition (the Competition Law) does not include specific provisions regarding medical devices and pharmaceutical products in Mexico. These product types are subject to the general provisions of the Competition Law. Owing to the nature of the pharmaceutical and medical devices business in Mexico, however, these industries tend to be severely scrutinised by the competition authorities, especially in the case of sale to governmental agencies.
In the case of medicines, the National Competition Authority (COFECE) has taken two major actions:
- a broad-scale investigation on possible collusion activities associated with manufacturing, production, distribution and sale of products, which led to formal sanctioning proceedings announced in 2019; and
- a study on competition conditions associated with patent expiry, published in 2017.
ii Transactional issues
Under Mexican law, no specific provisions or regulations pertain to transactional issues regarding legal entities engaged in the pharmaceutical or medical devices business. In practice, however, various issues may be encountered in the event of mergers, acquisitions, spin-offs and sales of assets in connection with these industries. Thus, the transfer of MA, licences and authorisations by virtue of the aforementioned transactions may take considerable time to be finalised. Likewise, any change to the manufacturing processes or the grounds on which an MA was issued must be duly reported to the health authorities and, in some cases, may be considered a 'change' or amendment to the conditions upon which a such authorisation was granted.
The foregoing may imply delays in transactions involving these types of products and may represent a challenge for legal entities carrying out these transactions to avoid the total or partial impossibility of carrying out the importation, manufacturing or marketing of pharmaceutical products or medical devices post-transaction.
Mexico is the second-largest medicine market in Latin America after Brazil, and one of the most developed, with high regulatory standards and a well-developed life sciences industry. With the change of government after the 2018 election, several public policy changes have been enacted that considerably affect the life sciences sector. These include a change in government procurement rules, banning distributors from participating in the largest centralised tender proceedings to acquire medicines and devices, and amendments to rules regarding national treatment for entities from countries with which Mexico has entered into free trade agreements, etc.
These amendments have forced life sciences companies to participate in a more active manner in these kinds of proceedings as well as to evaluate with greater care their participation in business with the Mexican public sector. Among these matters we can mention an investigation ordered by the Mexican President of the three major drug distributors in the country that has generated concern in the industry.
Another change was the replacement of the Seguro Popular with the National Institute for Health and Well-Being. In addition, it has been established that there is a necessity to create a National Drug Formulary for a National Health Compendium, which is expected to have a broader scope than the current one.
The new administration has taken very specific positions in connection with life sciences industries and health-related matters, the most relevant being those regarding the following topics:
Currently there is a law awaiting finalisation by Congress. This will, in essence, regulate the recreational use of cannabis and the decriminalisation of its use; however, the industrial and pharmaceutical use and processes have not yet been addressed or properly included in this proposal.
ii Software as a medical device
Software as a medical device has just been included as a regulated concept. Unfortunately, its proposed regulation lacks the necessary formal procedures and is in general a mere reference contemplated in a NOM whose enforcement and legality is debatable.
One of the most controversial subjects currently being addressed by the health authorities is vaping.
The restriction and control of vaping is a global trend. Because of Mexico's legal structure, vaping is not contemplated within the products regulated by the applicable provisions; however, the health authorities have considered a national health emergency in this regard and thus have attempted to restrict the importation, sale and use of these products.
These restrictions, owing to their nature and characteristics, have been challenged by diverse entities and individuals engaged in this industry having obtained favourable results from the competent courts.
Another relevant matter during the new administration is rules and provisions regarding food and beverage labelling. During the last quarter of 2019, Congress amended the Health Law and added diverse articles specifically related to food and beverage products' labelling. The main purpose of these amendments is to provide, in the clearest manner possible, information to the consumer as to the actual caloric content of products and possible elements of risk for their health such as salt, sugars, fats, caffeine, etc.
iv Dietary supplements
The importation and marketing of dietary supplements was less restricted during the past administration; however, the current administration has given special attention to their importation and marketing requirements. It is very likely this new attention to these products derives from the obesity emergency in the country and the publicity strategies of some entities engaged in the sale of these kinds of products.
Wellness is a concept that has been progressively increasing its presence in diverse jurisdictions. Mexico is no exception and a very noticeable increase in the marketing of these kinds of products has taken place during the past couple years.
Many of these 'wellness' products fall within the grey line of a 'medical' device, since many times these allege that their use may help improve certain medical conditions or bodily functions or that their use may improve an individual's general health and are, in the end, machines or apparatuses that are in contact with the human body.
The health authorities have increased their review and enforcement of these kinds of goods; however, due to their nature and marketing strategies, on many occasions it is difficult to enforce the applicable provisions and when enforced these may go beyond the actual scope of the applicable provisions.
Finally, it is worth noting that many of the health-related authorities are being restructured by the current administration, thus practical issues in the day-to-day relationship with these are a definitive trend, which it is hoped will diminish once these restructures are implemented.